Cleveland Clinic Florida

Fecal incontinence is a challenging condition of diverse etiology and devastating psychosocial impact. Multiple mechanisms may be involved in its pathophysiology, such as altered stool consistency and delivery of contents to the rectum, abnormal rectal capacity or compliance, decreased anorectal sensation, and pelvic floor or anal sphincter dysfunction. A detailed clinical history and physical examination are essential. Anorectal manometry, pudendal nerve latency studies, and electromyography are part of the standard primary evaluation. The evaluation of idiopathic fecal incontinence may require tests such as cinedefecography, spinal latencies, and anal mucosal electrosensitivity. These tests permit both objective assessment and focused therapy. Appropriate treatment options include biofeedback and sphincteroplasty. Biofeedback has resulted in 90 percent reduction in episodes of incontinence in over 60 percent of patients. Overlapping anterior sphincteroplasty has been associated with good to excellent results in 70 to 90 percent of patients. The common denominator between the medical and surgical treatment groups is the necessity of pretreatment physiologic assessment. It is the results of these tests that permit optimal therapeutic assignment. For example, pudendal nerve terminal motor latencies (PNTML) are the most important predictor factor of functional outcome. However, even the most experienced examiner's digit cannot assess PNTML. In the absence of pudendal neuropathy, sphincteroplasty is an excellent option. If neuropathy exists, however, then postanal or total pelvic floor repair remain viable surgical options for the treatment of idiopathic fecal incontinence. In the absence of an adequate sphincter muscle, encirclement procedures using synthetic materials or muscle transfer techniques might be considered. Implantation of a stimulating electrode into the gracilis neosphincter and artificial sphincter implantation are other valid alternatives. The final therapeutic option is fecal diversion. This article reviews the current status of the etiology and incidence of incontinence as well as the evaluation and treatment of this disabling condition.

Chronic hepatitis C (non-A, non-B hepatitis) is a common and often progressive viral liver disease. To assess the efficacy of therapy with the antiviral agent interferon alfa, we randomly assigned 166 patients with chronic hepatitis C to treatment with either 3 million or 1 million units of recombinant interferon alfa three times weekly for 24 weeks, or to no treatment. The probability of normalization or near normalization of the serum alanine aminotransferase levels after six months of interferon therapy was 46 percent in patients treated with 3 million units of interferon (P less than 0.001) and 28 percent in those treated with 1 million units (P less than 0.02), but only 8 percent in untreated patients. The serum alanine aminotransferase level became completely normal in 22 of the 26 patients (85 percent) who responded to treatment with 3 million units of interferon and 9 of the 16 patients (56 percent) who responded to treatment with 1 million units. The patients who received 3 million units of interferon had histologic improvement because of the regression of lobular and periportal inflammation. Relapse within six months after the completion of treatment occurred in 51 percent of the patients treated with 3 million units of interferon and 44 percent of those treated with 1 million units. We conclude that a 24-week course of interferon therapy is effective in controlling disease activity in many patients with hepatitis C, although relapse after the cessation of treatment is common.

BACKGROUND: We tested the safety and efficacy of eculizumab, a humanized monoclonal antibody against terminal complement protein C5 that inhibits terminal complement activation, in patients with paroxysmal nocturnal hemoglobinuria (PNH). METHODS: We conducted a double-blind, randomized, placebo-controlled, multicenter, phase 3 trial. Patients received either placebo or eculizumab intravenously; eculizumab was given at a dose of 600 mg weekly for 4 weeks, followed 1 week later by a 900-mg dose and then 900 mg every other week through week 26. The two primary end points were the stabilization of hemoglobin levels and the number of units of packed red cells transfused. Biochemical indicators of intravascular hemolysis and the patients' quality of life were also assessed. RESULTS: Eighty-seven patients underwent randomization. Stabilization of hemoglobin levels in the absence of transfusions was achieved in 49% (21 of 43) of the patients assigned to eculizumab and none (0 of 44) of those assigned to placebo (P<0.001). During the study, a median of 0 units of packed red cells was administered in the eculizumab group, as compared with 10 units in the placebo group (P<0.001). Eculizumab reduced intravascular hemolysis, as shown by the 85.8% lower median area under the curve for lactate dehydrogenase plotted against time (in days) in the eculizumab group, as compared with the placebo group (58,587 vs. 411,822 U per liter; P<0.001). Clinically significant improvements were also found in the quality of life, as measured by scores on the Functional Assessment of Chronic Illness Therapy-Fatigue instrument (P<0.001) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. Of the 87 patients, 4 in the eculizumab group and 9 in the placebo group had serious adverse events, none of which were considered to be treatment-related; all these patients recovered without sequelae. CONCLUSIONS: Eculizumab is an effective therapy for PNH.

PURPOSE: Constipation is a common complaint; however, clinical presentation varies with each individual. The aim of this study was to assess a standard scoring system for evaluation of constipated patients. MATERIALS AND METHODS: All consecutive patients with idiopathic constipation who were referred for anorectal physiologic testing were assessed. A subjective constipation score was calculated based on a detailed questionnaire that included over 100 constipation-related symptoms. Based on the questionnaire, scores ranged from 0 to 30, with 0 indicating normal and 30 indicating severe constipation. The constipation score was then compared with the objective findings of the physiology tests, which include colonic transit time (CTT), anal manometry (AM), cinedefecography (CD), and electromyography (EMG). Colonic inertia was defined as diffuse marker delay on CTT without evidence of paradoxical contraction on AM, CD, or EMG. Pelvic outlet obstruction was defined as paradoxical puborectalis contraction, rectal prolapse or rectoanal intussusception, rectocele, or sigmoidocele. RESULTS: A total of 232 patients (185 females and 47 males) of a mean age of 64.9 (range, 14-92) years were evaluated. All patients had a score of more than 15; on evaluation of the significance of different symptoms in the constipation score with the Pearson's linear correlation test, 8 of 18 factors were identified as significant (P < 0.05). These factors included frequency of bowel movements, painful evacuation, incomplete evacuation, abdominal pain, length of time per attempt, assistance for evacuation, unsuccessful attempts for evacuation per 24 hours, and duration of constipation. All 232 patients had objective obstruction attributable to one or more of the following causes: paradoxical puborectalis contraction (81), significant rectocele or sigmoidocele (48), rectoanal intussusception (64), and rectal prolapse (9). CONCLUSION: The proposed constipation scoring system correlated well with objective physiologic findings in constipated patients to allow uniformity in assessment of the severity of constipation.

IMPORTANCE: Evidence about the efficacy of laparoscopic resection of rectal cancer is incomplete, particularly for patients with more advanced-stage disease. OBJECTIVE: To determine whether laparoscopic resection is noninferior to open resection, as determined by gross pathologic and histologic evaluation of the resected proctectomy specimen. DESIGN, SETTING, AND PARTICIPANTS: A multicenter, balanced, noninferiority, randomized trial enrolled patients between October 2008 and September 2013. The trial was conducted by credentialed surgeons from 35 institutions in the United States and Canada. A total of 486 patients with clinical stage II or III rectal cancer within 12 cm of the anal verge were randomized after completion of neoadjuvant therapy to laparoscopic or open resection. INTERVENTIONS: Standard laparoscopic and open approaches were performed by the credentialed surgeons. MAIN OUTCOMES AND MEASURES: The primary outcome assessing efficacy was a composite of circumferential radial margin greater than 1 mm, distal margin without tumor, and completeness of total mesorectal excision. A 6% noninferiority margin was chosen according to clinical relevance estimation. RESULTS: Two hundred forty patients with laparoscopic resection and 222 with open resection were evaluable for analysis of the 486 enrolled. Successful resection occurred in 81.7% of laparoscopic resection cases (95% CI, 76.8%-86.6%) and 86.9% of open resection cases (95% CI, 82.5%-91.4%) and did not support noninferiority (difference, -5.3%; 1-sided 95% CI, -10.8% to ∞; P for noninferiority = .41). Patients underwent low anterior resection (76.7%) or abdominoperineal resection (23.3%). Conversion to open resection occurred in 11.3% of patients. Operative time was significantly longer for laparoscopic resection (mean, 266.2 vs 220.6 minutes; mean difference, 45.5 minutes; 95% CI, 27.7-63.4; P < .001). Length of stay (7.3 vs 7.0 days; mean difference, 0.3 days; 95% CI, -0.6 to 1.1), readmission within 30 days (3.3% vs 4.1%; difference, -0.7%; 95% CI, -4.2% to 2.7%), and severe complications (22.5% vs 22.1%; difference, 0.4%; 95% CI, -4.2% to 2.7%) did not differ significantly. Quality of the total mesorectal excision specimen in 462 operated and analyzed surgeries was complete (77%) and nearly complete (16.5%) in 93.5% of the cases. Negative circumferential radial margin was observed in 90% of the overall group (87.9% laparoscopic resection and 92.3% open resection; P = .11). Distal margin result was negative in more than 98% of patients irrespective of type of surgery (P = .91). CONCLUSIONS AND RELEVANCE: Among patients with stage II or III rectal cancer, the use of laparoscopic resection compared with open resection failed to meet the criterion for noninferiority for pathologic outcomes. Pending clinical oncologic outcomes, the findings do not support the use of laparoscopic resection in these patients. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00726622.

AIMS: The diagnosis of periprosthetic joint infection (PJI) can be difficult. All current diagnostic tests have problems with accuracy and interpretation of results. Many new tests have been proposed, but there is no consensus on the place of many of these in the diagnostic pathway. Previous attempts to develop a definition of PJI have not been universally accepted and there remains no reference standard definition. METHODS: This paper reports the outcome of a project developed by the European Bone and Joint Infection Society (EBJIS), and supported by the Musculoskeletal Infection Society (MSIS) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) Study Group for Implant-Associated Infections (ESGIAI). It comprised a comprehensive review of the literature, open discussion with Society members and conference delegates, and an expert panel assessment of the results to produce the final guidance. RESULTS: This process evolved a three-level approach to the diagnostic continuum, resulting in a definition set and guidance, which has been fully endorsed by EBJIS, MSIS, and ESGIAI. CONCLUSION: 2021;103-B(1):18-25.

The terminal complement inhibitor eculizumab was recently shown to be effective and well tolerated in patients with paroxysmal nocturnal hemoglobinuria (PNH). Here, we extended these observations with results from an open-label, non-placebo-controlled, 52-week, phase 3 clinical safety and efficacy study evaluating eculizumab in a broader PNH patient population. Eculizumab was administered by intravenous infusion at 600 mg every 7 +/- 2 days for 4 weeks; 900 mg 7 +/- 2 days later; followed by 900 mg every 14 +/- 2 days for a total treatment period of 52 weeks. Ninety-seven patients at 33 international sites were enrolled. Patients treated with eculizumab responded with an 87% reduction in hemolysis, as measured by lactate dehydrogenase levels (P < .001). Baseline fatigue scores in the FACIT-Fatigue instrument improved by 12.2 +/- 1.1 points (P < .001). Eculizumab treatment led to an improvement in anemia. The increase in hemoglobin level occurred despite a reduction in transfusion requirements from a median of 8.0 units of packed red cells per patient before treatment to 0.0 units per patient during the study (P < .001). Overall, transfusions were reduced 52% from a mean of 12.3 to 5.9 units of packed red cells per patient. Forty-nine patients (51%) achieved transfusion independence for the entire 52-week period. Improvements in hemolysis, fatigue, and transfusion requirements with eculizumab were independent of baseline levels of hemolysis and degree of thrombocytopenia. Quality of life measures were also broadly improved with eculizumab treatment. This study demonstrates that the beneficial effects of eculizumab treatment in patients with PNH are applicable to a broader population of PNH patients than previously studied. This trial is registered at http://clinicaltrials.gov as NCT00130000.

Connective tissue growth factor (CTGF) is a cysteine-rich peptide synthesized and secreted by fibroblastic cells after activation with transforming growth factor beta (TGF-beta) that acts as a downstream mediator of TGF-beta-induced fibroblast proliferation. We performed in vitro and in vivo studies to determine whether CTGF is also essential for TGF-beta-induced fibroblast collagen synthesis. In vitro studies with normal rat kidney (NRK) fibroblasts demonstrated CTGF potently induces collagen synthesis and transfection with an antisense CTGF gene blocked TGF-beta stimulated collagen synthesis. Moreover, TGF-beta-induced collagen synthesis in both NRK and human foreskin fibroblasts was effectively blocked with specific anti-CTGF antibodies and by suppressing TGF-beta-induced CTGF gene expression by elevating intracellular cAMP levels with either membrane-permeable 8-Br-cAMP or an adenylyl cyclase activator, cholera toxin (CTX). cAMP also inhibited collagen synthesis induced by CTGF itself, in contrast to its previously reported lack of effect on CTGF-induced DNA synthesis. In animal assays, CTX injected intradermally in transgenic mice suppressed TGF-beta activation of a human CTGF promoter/lacZ reporter transgene. Both 8-Br-cAMP and CTX blocked TGF-beta-induced collagen deposition in a wound chamber model of fibrosis in rats. CTX also reduced dermal granulation tissue fibroblast population increases induced by TGF-beta in neonatal mice, but not increases induced by CTGF or TGF-beta combined with CTGF. Our data indicate that CTGF mediates TGF-beta-induced fibroblast collagen synthesis and that in vivo blockade of CTGF synthesis or action reduces TGF-beta-induced granulation tissue formation by inhibiting both collagen synthesis and fibroblast accumulation.

We propose an epileptic seizure classification based exclusively on ictal semiology. In this semiological seizure classification (SSC), seizures are classified as follows: a. Auras are ictal manifestations having sensory, psychosensory, and experiential symptoms. b. Autonomic seizures are seizures in which the main ictal manifestations are objectively documented autonomic alterations. c. "Dialeptic" seizures have as their main ictal manifestations an alteration of consciousness that is independent of ictal EEG manifestations. The new term "dialeptic" seizure has been coined to differentiate this concept from absence seizures (dialeptic seizures with a generalized ictal EEG) and complex partial seizures (dialeptic seizures with a focal ictal EEG). d. Motor seizures are characterized mainly by motor symptoms and are subclassified as simple or complex. Simple motor seizures are characterized by simple, unnatural movements that can be elicited by electrical stimulation of the primary and supplementary motor area (myoclonic, tonic, clonic and tonic-clonic, versive). Complex motor seizures are characterized by complex motor movements that resemble natural movements but that occur in an inappropriate setting ("automatisms"). e. Special seizures include seizures characterized by "negative" features (atonic, astatic, hypomotor, akinetic, and aphasic seizures). The SSC identifies in detail the somatotopic distribution of the ictal semiology as well as the seizure evolution. The advantages of a pure SSC, as opposed to the current classification of the International League Against Epilepsy (ILAE), which is actually a classification of electroclinical syndromes, are discussed.

Laparoscopic surgery is excellent for treating benign disease of the colon and rectum, and for palliative operations for malignancy. Its application for cure of colorectal malignancy, however, must be approached with caution. Port site recurrence of tumour is a particular, and increasingly recognized, drawback. This review discusses the evidence to date to support prospective randomized trials of laparoscopic colectomy for cure of carcinoma.

BACKGROUND: Our primary objective was to demonstrate the utility and feasibility of the intraoperative assessment of colon and rectal perfusion using fluorescence angiography (FA) during left-sided colectomy and anterior resection. Anastomotic leak (AL) after colorectal resection increases morbidity, mortality, and, in cancer cases, recurrence rates. Inadequate perfusion may contribute to AL. The PINPOINT Endoscopic Fluorescence Imaging System allows for intraoperative assessment of anastomotic perfusion. STUDY DESIGN: This is a prospective, multicenter, open-label, clinical trial that assessed the feasibility and utility of FA for intraoperative perfusion assessment during left-sided colectomy and anterior resection at 11 centers in the United States. RESULTS: A total of 147 patients were enrolled, of whom 139 were eligible for analysis. Diverticulitis (44%), rectal cancer (25%), and colon cancer (21%) were the most prevalent indications for surgery. The mean level of anastomosis was 10 ± 4 cm from the anal verge. Splenic-flexure mobilization was performed in 81% and high ligation of the inferior mesenteric artery in 61.9% of patients. There was a 99% success rate for FA, and FA changed surgical plans in 11 (8%) patients, with the majority of changes occurring at the time of transection of the proximal margin (7%). Overall morbidity rates were 17%. The anastomotic leak rate was 1.4% (n = 2). There were no anastomotic leaks in the 11 patients who had a change in surgical plan based on intraoperative perfusion assessment with FA. CONCLUSIONS: PINPOINT is a safe and feasible tool for intraoperative assessment of tissue perfusion during colorectal resection. There were no anastomotic leaks in patients in whom the anastomosis was revised based on inadequate perfusion with FA.

INTRODUCTION AND HYPOTHESIS: A terminology and standardized classification has yet to be developed for those complications arising directly from the insertion of synthetic (prostheses) and biological (grafts) materials in female pelvic floor surgery. METHODS: This report on the above terminology and classification combines the input of members of the Standardization and Terminology Committees of two International Organizations, the International Urogynecological Association (IUGA) and the International Continence Society (ICS) and a Joint IUGA/ICS Working Group on Complications Terminology, assisted at intervals by many expert external referees. An extensive process of 11 rounds of internal and external review took place with exhaustive examination of each aspect of the terminology and classification. Decision-making was by collective opinion (consensus). RESULTS: A terminology and classification of complications related directly to the insertion of prostheses and grafts in female pelvic floor surgery has been developed, with the classification based on category (C), time (T) and site (S) classes and divisions, that should encompass all conceivable scenarios for describing insertion complications and healing abnormalities. The CTS code for each complication, involving three (or four) letters and three numerals, is likely to be very suitable for any surgical audit or registry, particularly one that is procedure-specific. Users of the classification have been assisted by case examples, colour charts and online aids (www.icsoffice.org/complication). CONCLUSION: A consensus-based terminology and classification report for prosthesis and grafts complications in female pelvic floor surgery has been produced, aimed at being a significant aid to clinical practice and research.

Interest in high-dose cytarabine (HDAC) for both induction and postremission therapy for acute myeloid leukemia (AML) prompted the Southwest Oncology Group (SWOG) to initiate a randomized trial comparing HDAC with standard-dose cytarabine (SDAC) for remission induction of previously untreated AML and to compare high-dose treatment versus conventional doses for consolidation therapy. Patients less than 65 years of age with de novo or secondary AML were randomized for induction between SDAC 200 mg/ m2/d for 7 days by continuous infusion or HDAC at 2 g/ m2 intravenously every 12 hours for 12 doses; both groups received daunorubicin (DNR) at 45 mg/m2/d intravenously for 3 days. Complete responders to SDAC were randomized to receive either two additional courses of SDAC plus DNR or one course of HDAC plus DNR. Complete responders to HDAC were nonrandomly assigned to receive one additional course of HDAC plus DNR. Of patients randomized between SDAC (n = 493) and HDAC (n = 172) induction, 361 achieved complete remission (CR). The CR rate was slightly poorer with HDAC: 55% versus 58% with SDAC for patients aged less than 50, and 45% (HDAC) versus 53% (SDAC) for patients aged 50 to 64 (age-adjusted one-tailed P = .96). With a median follow-up time of 51 months, survival was not significantly better with HDAC (P = .41); the estimated survival rate at 4 years was 32% (HDAC) versus 22% (SDAC) for those aged less than 50, and 13% (HDAC) versus 11% (SDAC) for those aged 50 to 64. However, relapse-free survival was somewhat better following HDAC Induction (P = .049): 33% (HDAC) versus 21% (SDAC) at 4 years for those aged less than 50, and 21% (HDAC) versus 9% (SDAC) for those aged 50 to 64. Induction with HDAC was associated with a significantly increased risk of fatal (P = .0033) and neurologic (P < .0001) toxicity. Among patients who achieved CR with SDAC, survival and disease-free survival (DFS) following consolidation randomization were not significantly better with HDAC compared with SDAC (P = .77 and .46, respectively). Patients who received both HDAC induction and consolidation had the best postremission outcomes; however, the proportion of CR patients who did not go on to protocol consolidation therapy was more than twice as high after HDAC induction compared with SDAC. Induction therapy with HDAC plus DNR was associated with greater toxicity than SDAC plus DNR, but with no improvement in CR rate or survival. Following CR induction with SDAC, consolidation with HDAC increased toxicity but not survival or DFS. In a nonrandomized comparison, patients who received both HDAC induction and consolidation had superior survival and DFS compared with those who received SDAC induction with either SDAC or HDAC consolidation.

INTRODUCTION: The routine use of a nasogastric tube after elective colorectal surgery is no longer mandatory. More recently, early feeding after laparoscopic colectomy has been shown to be safe and well tolerated. Therefore, the aim of our study was to prospectively assess the safety and tolerability of early oral feeding after elective "open" abdominal colorectal operations. MATERIALS AND METHODS: All patients who underwent elective laparotomy with either colon or small bowel resection between November 1992 and April 1994 were prospectively randomized to one of the following two groups: group 1: early oral feeding--all patients received a clear liquid diet on the first postoperative day followed by a regular diet as tolerated; group 2: regular feeding--all patients were treated in the "traditional" way, with feeding only after the resolution of their postoperative ileus. The nasogastric tube was removed from all patients in both groups immediately after surgery. The patients were monitored for vomiting, bowel movements, nasogastric tube reinsertion, time of regular diet consumption, complications, and length of hospitalization. The nasogastric tube was reinserted if two or more episodes of vomiting of more than 100 mL occurred in the absence of bowel movement. Ileus was considered resolved after a bowel movement in the absence of abdominal distention or vomiting. RESULTS: One hundred sixty-one consecutive patients were studied, 80 patients in group 1 (34 males and 46 females, mean age 51 years [range 16-82 years]), and 81 patients in group 2 (43 males and 38 females, mean age 56 years [range 20-90 years]). Sixty-three patients (79%) in the early feeding group tolerated the early feeding schedule and were advanced to regular diet within the next 24 to 48 hours. There were no significant differences between the early and regular feeding groups in the rate of vomiting (21% vs. 14%), nasogastric tube reinsertion (11% vs. 10%), length of ileus (3.8 +/- 0.1 days vs. 4.1 +/- 0.1 days), length of hospitalization (6.2 +/- 0.2 days vs. 6.8 +/- 0.2 days), or overall complications (7.5% vs. 6.1%), respectively, (p = NS for all). However, the patients in the early feeding group tolerated a regular diet significantly earlier than did the patients in the regular feeding group (2.6 +/- 0.1 days vs. 5 +/- 0.1 days; p < 0.001). CONCLUSION: Early oral feeding after elective colorectal surgery is safe and can be tolerated by the majority of patients. Thus, it may become a routine feature of postoperative management in these patients.

This clinical practice guideline represents a collaborative effort between the American Society of Colon and Rectal Surgeons (ASCRS) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). The ASCRS Clinical Practice Guidelines Committee is composed of society members who are chosen because they have demonstrated expertise in the specialty of colon and rectal surgery. In a collaborative effort, the ASCRS Clinical Practice Guidelines Committee and members of the SAGES Surgical Multimodal Accelerated Recovery Trajectory Enhanced Recovery Task Force and Guidelines Committee have joined together to produce this guideline, written and approved by both societies. The combined ASCRS/SAGES panel worked together to develop the statements in this guideline and approved these final recommendations. Through this effort, the ASCRS and SAGES continue their dedication to ensuring high-quality perioperative patient care. Previous guidelines on perioperative care for colon1 and rectal2 surgery included studies identified up to January 2012 with significant literature published since then. The combined ASCRS/SAGES committee was created to define current best-quality care for enhanced recovery after colon and rectal surgery. This clinical practice guideline is based on the best available evidence. These guidelines are inclusive and not prescriptive. Their purpose is to provide information on which decisions can be made rather than to dictate a specific form of treatment. These guidelines are intended for the use of all practitioners, healthcare workers, and patients who desire information about the management of the conditions addressed by the topics covered in these guidelines. It should be recognized that these guidelines should not be deemed inclusive of all proper methods of care or exclusive of methods of care reasonably directed toward obtaining the same results. The ultimate judgment regarding the propriety of any specific procedure must be made by the physician in light of all of the circumstances presented by the individual patient. STATEMENT OF THE PROBLEM Contemporary colorectal surgery is often associated with long length of stay (8 days for open surgery and 5 days for laparoscopic surgery),3 high cost,3 and rates of surgical site infection approaching 20%.4 During the hospital stay for elective colorectal surgery, the incidence of perioperative nausea and vomiting (PONV) may be as high as 80% in patients with certain risk factors.5 After discharge from colorectal surgery, readmission rates have been noted as high as 35.4%.6 An enhanced recovery protocol (ERP) is a set of standardized perioperative procedures and practices that is applied to all patients undergoing a given elective surgery. In general, these protocols are not intended for emergent cases, but components of them certainly could apply to the emergent/urgent patient. Also known as fast-track protocols or enhanced recovery after surgery (ERAS)1 protocols, the content of these specific protocols may vary significantly, but all are designed as a means to improve patient outcomes. Outcomes of interest to patients and providers include freedom from nausea, freedom from pain at rest, early return of bowel function, improved wound healing, and early hospital discharge.7 Although numerous perioperative protocols currently exist, this clinical practice guideline will evaluate the strength of evidence in support of measures to improve patient recovery after elective colon and rectal resections. A 2011 Cochrane review found that ERPs were associated with a reduction in overall complications and length of stay when compared with conventional perioperative patient management.8 Subsequent studies have shown that ERPs are associated with reduced healthcare costs and improved patient satisfaction.4 ERPs are also associated with improved outcomes regardless of whether patients undergo laparoscopic or open surgery.9 Studies have also shown that ERPs cannot simply be implemented and forgotten but require a continued audit process in place to guide compliance and to continue to improve quality.10–13 There are many different preoperative, intraoperative, and postoperative components in a typical ERP, and it is difficult to identify which are the most beneficial components of the bundle of measures, because they are generally all implemented simultaneously. However, one retrospective review of 8 years of compliance with an ERP identified these items as the strongest predictors of shorter length of stay: no nasogastric tube, early mobilization, early oral nutrition (early discontinuance of intravenous fluids), early removal of epidural, early removal of and This clinical practice guideline will evaluate the evidence ERPs for colorectal surgery. of the SAGES and ASCRS Practice Guidelines Committee worked in of these guidelines from to final were approved by committee and These guidelines were a standardized for the of all of clinical practice which for of a review of the and of the of the of and of the The of specific of studies and of evidence for are available in the but all of the an of and the Cochrane of a of on and were from to and were to of the from the were also in certain and were given in these guidelines. After all of the were a of been identified for and of were for review and evidence with of the evidence based on of the by The final of was the of and by the American of Previous guidelines on perioperative care for colon1 and rectal2 surgery included studies identified up to January with significant literature published since The of and A of and discharge should be with the patient surgery. of based on discharge for patients undergoing colorectal surgery have been in an which that patients are for discharge when is of oral recovery of function, pain with oral to to no evidence of complications or and patient to the Although are studies that at the of regarding and discharge these are a of and have the of an ERP that discharge on hospital length of compliance with an ERP that patient and discharge been shown in and to be associated with length of stay and The to the discharge to for been as a of However, are between the when patients are discharge and with a to days of length of stay high ERP and on should be included in the of based on The of an is an risk for a length of stay after colorectal The of patient to improve of and hospital length of and hospital costs been in and as as a in is beneficial but a demonstrated that patient was most in the and studies have shown that by an of the site and patient was associated with improved postoperative of reduced rates of postoperative and improved patient regardless of and studies have the of an on is an of been shown to be the most of readmission after from to of an in which patients were in management and an enhanced recovery reduced overall from to and for from to a perioperative care been included in a and review of process measures to postoperative and A may be continued of based on high-quality should be to the of because it been shown to be and to improve of clinical have the of elective surgery. These studies have shown that of to of surgery is associated with and at the of surgery. The current practice guidelines of the and Society of support this should be surgery in of based on The use of should be with the purpose to by surgery and A Cochrane review in identified in and as to the or found in or The of the review was that was associated with a reduction in the length of hospital stay when compared with or in patients undergoing elective surgery. was not associated with or perioperative complications when compared with or studies were to because of a of A of studies patients no overall in length of stay all of the included when the of patients undergoing surgery, was a in of length of A of whether the of was and found that both and high of surgery improved length of stay when compared with However, when compared with or not a in the length of to the of complications regardless of the or on this most surgery may provide clinical as bowel oral bowel colorectal surgery is the and is associated with reduced of based on A for perioperative care in elective surgery that bowel should not be in surgery based on the it and a 2011 Cochrane no to in However, evidence regarding the of oral to should be Although to be no of in of a of with a reduction in surgical site infection and site with no in the of infection after elective colorectal These are with In a retrospective of a in the in was associated with overall surgical site and retrospective studies in different and a hospital a reduction in surgical site infection with the of to The Surgical a reduction in surgical site infection and a reduction in postoperative in patients who with patients who no bowel was as of a perioperative care bundle at a significant in surgical site infection was elective surgery may be for patients undergoing elective colorectal surgery with or significant of based on as of the of a been as a for postoperative to a surgical procedure with the to the postoperative and The of is were both and These studies were of to of these and on the of in patients who colorectal not The studies with patient evidence for the of on function, of length of and Studies on colorectal and surgery were in of measures, of the and compliance rates with these which the of and the to However, these studies support the of to improve or surgery. There were retrospective and and that in function, and of with at may have the most to with However, in the of or of in compliance with protocols, and these at postoperative studies no in postoperative rates and hospital length of stay with compared with or postoperative or have been should be as a of the enhanced care of based on ERPs are and require between many different to the care of the surgical patient. to all of these protocols are which include preoperative, intraoperative, and postoperative that care between all and for all The current of not been but all of the studies enhanced recovery conventional care have included as of the However, it is not the of standardized that to improved because a by improved outcomes for patients undergoing who were by enhanced recovery compared with a conventional care that included standardized protocol is The of standardized an ERP is not to outcomes. demonstrated in a that to protocol was high in the and but recovery at a of but length of stay was 5 of patients in that were on and that ERPs were to A collaborative from the Society that patients with protocol compliance length of stay and complications than patients with compliance all of the perioperative A clinical audit that compliance with an ERP was associated with shorter length of However, this not been an because a retrospective ERP compliance in clinical practice compared to a clinical the not any in length of or between the Surgical A bundle of measures should be in place to surgical site of based on A care bundle is a set of practices that have been to improve patient outcomes. In a reduction in surgical site from to after of a measures included a with oral of and of of the surgical with measures included use of a wound and use of a wound and measures included removal of the and of the with and perioperative of were also components of the significant was in and A review and studies that use of an surgical care bundle for patients undergoing colorectal surgery reduced the risk of in bundle in the care Although of the studies in this the care all included from a of and for measures that have been included in are a reduction in intravenous for high of and for 5 days vary between different protocols, and the to which a in difficult to A pain management should be and implemented the of of based on studies have demonstrated that is associated with return of bowel and shorter length of of the to is to as oral and rather than them on an The use of or when not and of or have been shown to improve postoperative and and of their that have been shown to surgical and clinical studies have shown that may the risk of one demonstrated in patients of in the after surgery, the risk of was not This on rates to be and and in patients for a days after surgery. demonstrated a risk of in patients undergoing but not elective colorectal surgery The evidence is and not support the of in patients with perioperative and have also been to improve and and postoperative but and may the and of to be of have also been shown to and improve and postoperative the risk of wound or However, are and with have shown in patients undergoing open and laparoscopic colorectal In that the with a been associated with length of stay compared with in laparoscopic colorectal surgery to provide than at the Although many a the of and to and is for open colorectal surgery, but not for use in laparoscopic colorectal surgery. based on Although is the patient or to pain in patients undergoing open colorectal the by not support a recovery in laparoscopic surgery. and have shown that no or may hospital discharge in laparoscopic surgery. This is to the incidence of and postoperative be in patients at high risk of in postoperative pain management could be patients with a high risk of to an is an of a of a of and been shown to provide than an of or combined with of can provide for long The of as or can be to improve and certain rates have been from to methods to the of the conventional of to identify the as and can be to the of and should be by for risk for postoperative of based on The incidence of postoperative nausea and vomiting (PONV) all of the patients in a care is patients with risk for may have an incidence of as high as hospital costs and patient of been shown to improve patient guideline risk of all patients undergoing and to and the most practice guideline from the not risk have been to identify patients at high risk for Although of and for the use of a protocol for all patients of because to be and A of elective surgical patients that the of a specific for not the incidence in However, a by the same in which risk was combined with a specific for a significant reduction in in all with an reduction in A significant reduction in been with this of risk with a specific in should be in all patients to of based on high-quality Although many have been to postoperative nausea, and the for it that is the best in of patients that a reduced the risk of in the to and that patients a high to for that use of the most on the of in A for patients to be high risk for is the of at of and at from that the of with is to in the of in to patients undergoing A of patients demonstrated that combined with than with and the use of In to A of patients that patients for and pain at Although have regarding associated with in an shown that of 8 of not to a significant when compared with to include the use of intravenous intravenous and There is evidence that the of intravenous with to a is to a with A of patients that the use of intravenous given surgery or in the care reduced the risk of nausea and it was not in given after the of There have been clinical the of as for in surgery, and a that the risk of nausea and vomiting is in patients who the of reduced in the of the use of and it a Although the included studies of and a of were the of evidence is in support of of should be to and of based on or can function, postoperative and hospital based on as or should be because a in the of between different studies the same the to a of have been and surgery have been and the bowel is from the not The by surgical to a reduction of in the of of should not to by not but in the of by complications as However, should not be and it should be or not by because is after a of not intravenous in patients after In these should be with after ensuring that the patient is on these a of of is to the from postoperative which is associated with and hospital should be as in patients undergoing colorectal surgery. of based on from studies in and from of that should be to to the risk of studies have an between the use of and an incidence of postoperative and in surgical In patients and in patients undergoing colorectal surgery associated with significant the use of is of based on intravenous based on measures of as or or based on of or can guide to whether to intravenous of have shown that postoperative and length of hospital in patients undergoing patients have been but have been noted to include patients with a of surgery years with evidence of of one or and However, it must be that the of in patients of the of the included studies was than is currently with a and in the of an ERP have to the same In patients with in perioperative and surgical care to have the demonstrated of The of the patients undergoing surgery colorectal surgery, and the in the of an shown a significant of complications and in patients with risk the of are in the of of the and postoperative of use of in the and perioperative care. can be in at or at when An cannot be because a studies have compared different of These studies on the of different intravenous to with with Their that patients with with than patients with with and that postoperative complications or length of hospital stay were from in patients have about the use of because of the risk of the for and However, and retrospective to these in surgical It is to use rather than in surgical patients at risk of or with Surgical A surgical should be the expertise is available and of based on high-quality There is high-quality evidence in cases, when by laparoscopic of colorectal conditions is beneficial compared with open surgery. of patients with colon the Colon from and the Colon or from the both to be to open in of outcomes return of bowel function, postoperative and shorter hospital of have shown reduced perioperative wound and laparoscopic compared with open that patients undergoing have to reduced use of and improved of early that laparoscopic not provide the of in rates in colon from of rectal are and also reduced and shorter and length of The in these are with the Surgical and the as as The evidence been in high-quality Cochrane and of laparoscopic in colon and in rectal These studies support the of of the early have that outcomes may be with the laparoscopic for rectal clinical to that was to open surgery in a of of these for in of and to the are available from these the outcomes are from have shown that outcomes are for laparoscopic of rectal and outcomes are to open In of colon and rectal with years of rates of and overall of have also about the for but and studies have often shown to be associated with or overall to reduced length of stay and reduced The is the of with an ERP, as demonstrated in the Multimodal The use of and nasogastric for colorectal surgery should be of based on should not be in colorectal surgery and should be for patients who develop postoperative to have demonstrated that patients who not nasogastric in the postoperative have no in nausea, to return of bowel function, or length of stay when compared with patients who nasogastric who not nasogastric also oral days than patients who nasogastric that nasogastric may nutrition in the postoperative the use of nasogastric was associated with a risk of associated are no to support the use of to identify and have been in all have demonstrated no significant in or a of postoperative complications in patients who of published studies no to in patients with or colorectal The of the in to the not to the use of patients with or colorectal who for the have rates of and complications when compared with patients in which a was not of the that may be beneficial for a clinical of patients with rectal After Rectal for Rectal that the use of after rectal not any to the use of also been associated with and as as and patient is associated with shorter length of of based on of include and and The associated with can be reduced with enhanced recovery for colorectal surgery, of early from any at all to 8 by postoperative in ERPs compared with conventional In with from to and was a significant of discharge in most but not Although is associated with shorter hospital studies the of specific to compared with early A review identified 8 in and in surgery, of the studies were in the of an ERP, and overall was There was significant between the different of the 5 studies complications found any and of studies a in length of stay in of the The review that is evidence to guide on best practices to and improve to postoperative after a of with on outcomes. patients to care or a specific with and found no in the of or length of In patients on to on than who not the were no in length of function, or open surgery patients to early early or in the early the hospital but was no significant in A the of to after colorectal surgery an ERP found when of and were was no on hospital stay or complications in the recovery of The that to with were not in an a in to patients colon surgery to a and or to conventional care. The shorter hospital stay and shorter to There were no in or between the should be a after elective colorectal surgery. of based on and demonstrated that early recovery and the hospital length of The of and were also with early in open surgery no significant in any rates of nasogastric length of length of or overall studies demonstrated the in laparoscopic surgery with an The to of early was identified as the in open surgery by colorectal and use of laparoscopic surgery were associated with early postoperative on the both the guidelines and guidelines early in patients undergoing enhanced However, with early oral providers must be that the risk of vomiting for to after colorectal surgery is in in and may be associated with a reduction in the length of hospital of based on high-quality after elective colorectal surgery was as a for and in have been and have been that to postoperative care was associated with to and bowel than postoperative with no significant in postoperative or a shorter hospital length of no significant on length of review an of on bowel of the studies as as of and the A Cochrane review of studies and surgery patients found evidence that who after an return of bowel and were to and have bowel than who not There was a in hospital length of stay but no in complications or overall of care between who or not However, the studies were generally of and surgery and were not to their are the risk and the guidelines for enhanced recovery after elective colorectal surgery after is to recovery after open colorectal surgery, use in surgery of based on The of in open surgery have been generally and to recovery of with and compared with and a shorter hospital length of stay in the compared with for patients undergoing open In the by the of the in hospital and reduced postoperative was in the of an A retrospective review of patients that patients who not the of also the of shorter to hospital and reduction in postoperative compared with not a significant with that was in patients after open surgery compared with the have also the of the studies were in that were no of after laparoscopic A Cochrane review of studies that was than in and and that was and in postoperative but the studies were in open and no ERP was noted in In laparoscopic colorectal surgery, the of are from studies results. studies found return of and shorter length of stay in the found a incidence of postoperative but no in length of hospital stay with or after laparoscopic The collaborative with rates of postoperative in laparoscopic patients who but no significant in length of A of 5 laparoscopic surgery studies by a risk reduction in the of postoperative with no on length of hospital stay or studies have that no in the rates of postoperative or length of stay to laparoscopic colorectal surgery with an to the that the of to an ERP will to in clinical outcomes in patients after open or but not have a after laparoscopic colorectal It may be difficult to the of in laparoscopic surgery in the of an A retrospective review of patients undergoing laparoscopic colorectal surgery not to patient outcomes with a was in this In retrospective of open and laparoscopic were should be in the early postoperative after recovery of based on and different in the postoperative of the of on clinical intravenous should be in the early postoperative recovery and of as after should be when deemed postoperative should be and to It is to because the from studies in patients that of patients are when intravenous are given based on clinical of Although also in the postoperative because clinical and the of of intravenous studies and in surgical patients on surgical are by should be by the and with of after ensuring that the patient is should be of elective or rectal when not a of of based on is in colorectal surgery for and of who undergo for days have the risk of a postoperative infection patients who develop a an will develop a that to hospital stay and risk of studies have the of removal on the postoperative as of an In a of patients who a risk of was with early In of with of patients with on the postoperative by in all A early removal of removal of at the of of after colon and rectal surgery found that was not associated with early and rectal the risk of of This was not to in rates of patients with after or surgery a of patients to early removal compared with removal after of significant in rates between early and removal were identified in this A the of on early postoperative recovery a retrospective of a ERP The of after early removal in patients who elective colorectal surgery was with were in the early postoperative and because of these patients pain on a In this rates of were not different between patients with and It is that may be colon resections. A of patients who elective colon on an ERP it was for management or to and it was at the of the In this was the most the of was and was in of the in of patients and in should be of rectal resections. of based on on the and of to the may the risk of postoperative retrospective studies have identified a risk of after early removal in rectal retrospective studies have An removal after rectal on and 5 found that the rates of were and This was not to identify in with patients compared and 5 removal after rectal and found that rates of were after removal rates of were in the removal A the rectal demonstrated rates of and for and 5 removal this not because of an However, the of in the was to published rates for early removal after In this rates of were with early removal These that patients who undergo rectal surgery may have removal on the postoperative as patients who undergo a who undergo rectal are at an risk of with of removal should be for patients with and

OBJECTIVE: To determine the disease-free survival (DFS) and recurrence after the treatment of patients with rectal cancer with open (OPEN) or laparoscopic (LAP) resection. BACKGROUND: This randomized clinical trial (ACOSOG [Alliance] Z6051), performed between 2008 and 2013, compared LAP and OPEN resection of stage II/III rectal cancer, within 12 cm of the anal verge (T1-3, N0-2, M0) in patients who received neoadjuvant chemoradiotherapy. The rectum and mesorectum were resected using open instruments for rectal dissection (included hybrid hand-assisted laparoscopic) or with laparoscopic instruments under pneumoperitoneum. The 2-year DFS and recurrence were secondary endpoints of Z6051. METHODS: The DFS and recurrence were not powered, and are being assessed for superiority. Recurrence was determined at 3, 6, 9, 12, and every 6 months thereafter, using carcinoembryonic antigen, physical examination, computed tomography, and colonoscopy. In all, 486 patients were randomized to LAP (243) or OPEN (243), with 462 eligible for analysis (LAP = 240 and OPEN = 222). Median follow-up is 47.9 months. RESULTS: The 2-year DFS was LAP 79.5% (95% confidence interval [CI] 74.4-84.9) and OPEN 83.2% (95% CI 78.3-88.3). Local and regional recurrence was 4.6% LAP and 4.5% OPEN. Distant recurrence was 14.6% LAP and 16.7% OPEN.Disease-free survival was impacted by unsuccessful resection (hazard ratio [HR] 1.87, 95% CI 1.21-2.91): composite of incomplete specimen (HR 1.65, 95% CI 0.85-3.18); positive circumferential resection margins (HR 2.31, 95% CI 1.40-3.79); positive distal margin (HR 2.53, 95% CI 1.30-3.77). CONCLUSION: Laparoscopic assisted resection of rectal cancer was not found to be significantly different to OPEN resection of rectal cancer based on the outcomes of DFS and recurrence.

ᅟ: Obstruction and perforation due to colorectal cancer represent challenging matters in terms of diagnosis, life-saving strategies, obstruction resolution and oncologic challenge. The aims of the current paper are to update the previous WSES guidelines for the management of large bowel perforation and obstructive left colon carcinoma (OLCC) and to develop new guidelines on obstructive right colon carcinoma (ORCC). Methods: The literature was extensively queried for focused publication until December 2017. Precise analysis and grading of the literature has been performed by a working group formed by a pool of experts: the statements and literature review were presented, discussed and voted at the Consensus Conference of the 4th Congress of the World Society of Emergency Surgery (WSES) held in Campinas in May 2017. Results: CT scan is the best imaging technique to evaluate large bowel obstruction and perforation. For OLCC, self-expandable metallic stent (SEMS), when available, offers interesting advantages as compared to emergency surgery; however, the positioning of SEMS for surgically treatable causes carries some long-term oncologic disadvantages, which are still under analysis. In the context of emergency surgery, resection and primary anastomosis (RPA) is preferable to Hartmann's procedure, whenever the characteristics of the patient and the surgeon are permissive. Right-sided loop colostomy is preferable in rectal cancer, when preoperative therapies are predicted.With regards to the treatment of ORCC, right colectomy represents the procedure of choice; alternatives, such as internal bypass and loop ileostomy, are of limited value.Clinical scenarios in the case of perforation might be dramatic, especially in case of free faecal peritonitis. The importance of an appropriate balance between life-saving surgical procedures and respect of oncologic caveats must be stressed. In selected cases, a damage control approach may be required.Medical treatments including appropriate fluid resuscitation, early antibiotic treatment and management of co-existing medical conditions according to international guidelines must be delivered to all patients at presentation. Conclusions: The current guidelines offer an extensive overview of available evidence and a qualitative consensus regarding management of large bowel obstruction and perforation due to colorectal cancer.

Importance: There is limited evidence regarding early treatment of novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection to mitigate symptom progression. Objective: To examine whether high-dose zinc and/or high-dose ascorbic acid reduce the severity or duration of symptoms compared with usual care among ambulatory patients with SARS-CoV-2 infection. Design, Setting, and Participants: This multicenter, single health system randomized clinical factorial open-label trial enrolled 214 adult patients with a diagnosis of SARS-CoV-2 infection confirmed with a polymerase chain reaction assay who received outpatient care in sites in Ohio and Florida. The trial was conducted from April 27, 2020, to October 14, 2020. Intervention: Patients were randomized in a 1:1:1:1 allocation ratio to receive either 10 days of zinc gluconate (50 mg), ascorbic acid (8000 mg), both agents, or standard of care. Outcomes: The primary end point was the number of days required to reach a 50% reduction in symptoms, including severity of fever, cough, shortness of breath, and fatigue (rated on a 4-point scale for each symptom). Secondary end points included days required to reach a total symptom severity score of 0, cumulative severity score at day 5, hospitalizations, deaths, adjunctive prescribed medications, and adverse effects of the study supplements. Results: A total of 214 patients were randomized, with a mean (SD) age of 45.2 (14.6) years and 132 (61.7%) women. The study was stopped for a low conditional power for benefit with no significant difference among the 4 groups for the primary end point. Patients who received usual care without supplementation achieved a 50% reduction in symptoms at a mean (SD) of 6.7 (4.4) days compared with 5.5 (3.7) days for the ascorbic acid group, 5.9 (4.9) days for the zinc gluconate group, and 5.5 (3.4) days for the group receiving both (overall P = .45). There was no significant difference in secondary outcomes among the treatment groups. Conclusions and Relevance: In this randomized clinical trial of ambulatory patients diagnosed with SARS-CoV-2 infection, treatment with high-dose zinc gluconate, ascorbic acid, or a combination of the 2 supplements did not significantly decrease the duration of symptoms compared with standard of care. Trial Registration: ClinicalTrials.gov Identifier: NCT04342728.

BACKGROUND: The anatomic difficulties that we have to deal with in open surgery for rectal cancer have not been overcome with the laparoscopic approach. In the search for a solution, a change of concept arose: approaching the rectum from below. The main objectives of this study were to show the potential advantages of the hybrid transabdominal-transanal total mesorectal excision (taTME). This approach may improve quality of the mesorectal specimens. Second, proctectomy can be technically easier and more safely performed "down to up," which would result in shorter surgical times, lower conversion rates, and less morbidity. STUDY DESIGN: A prospective series of hybrid taTME was conducted from October 2011 to November 2014. RESULTS: During the study period, 140 procedures were performed. Mean operative time was 166 minutes. There were no conversions or intraoperative complications. Macroscopic quality assessment of the resected specimen was complete in 97.1% and nearly complete in 2.1%. Thirty-day morbidity was minor (Clavien-Dindo I + II) in 24.2% and major (Clavien-Dindo III + IV) in 10 %. No patient died within the first 30 days postsurgery (Clavien-Dindo V). The mean follow-up was 15 months, with a 2.3% local recurrence rate and a 7.6% rate of systemic recurrence. CONCLUSIONS: Pathologic analysis showed a very good macroscopic quality of TME specimens, which is the most important prognostic factor in rectal cancer. Intraoperative outcomes regarding conversion, surgical times, and intraoperative complications are very satisfactory. Short-term morbidity and oncologic outcomes are as good as in other laparoscopic TME series.

In Brief Background: Sacral nerve stimulation has been approved for use in treating urinary incontinence in the United States since 1997, and in Europe for both urinary and fecal incontinence (FI) since 1994. The purpose of this study was to determine the safety and efficacy of sacral nerve stimulation in a large population under the rigors of Food and Drug Administration-approved investigational protocol. Methods: Candidates for SNS who provided informed consent were enrolled in this Institutional Review Board-approved multicentered prospective trial. Patients showing ≥50% improvement during test stimulation received chronic implantation of the InterStim Therapy (Medtronic; Minneapolis, MN). The primary efficacy objective was to demonstrate that ≥50% of subjects would achieve therapeutic success, defined as ≥50% reduction of incontinent episodes per week at 12 months compared with baseline. Results: A total of 133 patients underwent test stimulation with a 90% success rate, and 120 (110 females) of a mean age of 60.5 years and a mean duration of FI of 6.8 years received chronic implantation. Mean follow-up was 28 (range, 2.2–69.5) months. At 12 months, 83% of subjects achieved therapeutic success (95% confidence interval: 74%–90%; P < 0.0001), and 41% achieved 100% continence. Therapeutic success was 85% at 24 months. Incontinent episodes decreased from a mean of 9.4 per week at baseline to 1.9 at 12 months and 2.9 at 2 years. There were no reported unanticipated adverse device effects associated with InterStim Therapy. Conclusion: Sacral nerve stimulation using InterStim Therapy is a safe and effective treatment for patients with FI. The purpose of this study was to determine the safety and efficacy of SNS in a large population under the rigors of an FDA-approved investigational protocol. 133 patients underwent test stimulation with a 90% success rate, and 120 (110 females), of a mean age of 60.5 years and a mean FI duration of 6.8 years, received chronic implantation. Sacral nerve stimulation using IterStim Therapy is a safe and effective treatment for patients with FI.