Prophylactic antibiotics for penetrating abdominal trauma: duration of use and antibiotic choice.

BACKGROUND: Penetrating abdominal trauma (PAT) is a common type of trauma leading to admission to hospital, which often progresses to septic complications. Antibiotics are commonly administered as prophylaxis prior to laparotomy for PAT. However, an earlier Cochrane Review intending to compare antibiotics with placebo identified no relevant randomised controlled trials (RCTs). Despite this, many RCTs have been carried out that compare different agents and durations of antibiotic therapy. To date, no systematic review of these trials has been performed. OBJECTIVES: To assess the effects of antibiotics in penetrating abdominal trauma, with respect to the type of agent administered and the duration of therapy. SEARCH METHODS: We searched the following electronic databases for relevant randomised controlled trials, from database inception to 23 July 2019; Cochrane Injuries Group's Specialised Register, CENTRAL, MEDLINE Ovid, MEDLINE Ovid In-Process & Other Non-Indexed Citations, MEDLINE Ovid Daily and Ovid OLDMEDLINE, Embase Classic + Embase Ovid, ISI Web of Science (SCI-EXPANDED, SSCI, CPCI-S & CPSI-SSH), and two clinical trials registers. We also searched reference lists from included studies. We applied no restrictions on language or date of publication. SELECTION CRITERIA: We included RCTs only. We included studies involving participants of all ages, which were conducted in secondary care hospitals only. We included studies of participants who had an isolated penetrating abdominal wound that breached the peritoneum, who were not already taking antibiotics. DATA COLLECTION AND ANALYSIS: Two study authors independently extracted data and assessed risk of bias. We used standard Cochrane methods. We aggregated study results using a random-effects model. We also conducted trial sequential analysis (TSA) to help reduce type I and II errors in our analyses. MAIN RESULTS: We included 29 RCTs, involving a total of 4458 participants. We deemed 23 trials to be at high risk of bias in at least one domain. We are uncertain of the effect of a long course of antibiotic prophylaxis (> 24 hours) compared to a short course (≤ 24 hours) on abdominal surgical site infection (RR 1.00, 95% CI 0.81 to 1.23; I² = 0%; 7 studies, 1261 participants; very low-quality evidence), mortality (Peto OR 1.67, 95% CI 0.73 to 3.82; I² = 8%; 7 studies, 1261 participants; very low-quality evidence), or intra-abdominal infection (RR 1.23, 95% CI 0.84 to 1.80; I² = 0%; 6 studies, 111 participants; very-low quality evidence). Based on very low-quality evidence from fifteen studies, involving 2020 participants, which compared different drug regimens with activity against three classes of gastrointestinal flora (gram positive, gram negative, anaerobic), we are uncertain whether there is a benefit of one regimen over another. TSA showed the majority of comparisons did not cross the alpha adjusted boundary for benefit or harm, or reached the required information size, indicating that further studies are required for these analyses. However, in the three analyses which crossed the boundary for futility, further studies are unlikely to show benefit or harm. AUTHORS' CONCLUSIONS: Very low-quality evidence means that we are uncertain about the effect of either the duration of antibiotic prophylaxis, or the superiority of one drug regimen over another for penetrating abdominal trauma on abdominal surgical site infection rates, mortality, or intra-abdominal infections. Future RCTs should be adequately powered, test currently used antibiotics, known to be effective against gut flora, use methodology to minimise the risk of bias, and adequately report the level of peritoneal contamination encountered at laparotomy.

Closure methods for laparotomy incisions for preventing incisional hernias and other wound complications.

BACKGROUND: Surgeons who perform laparotomy have a number of decisions to make regarding abdominal closure. Material and size of potential suture types varies widely. In addition, surgeons can choose to close the incision in anatomic layers or mass ('en masse'), as well as using either a continuous or interrupted suturing technique, of which there are different styles of each. There is ongoing debate as to which suturing techniques and suture materials are best for achieving definitive wound closure while minimising the risk of short- and long-term complications. OBJECTIVES: The objectives of this review were to identify the best available suture techniques and suture materials for closure of the fascia following laparotomy incisions, by assessing the following comparisons: absorbable versus non-absorbable sutures; mass versus layered closure; continuous versus interrupted closure techniques; monofilament versus multifilament sutures; and slow absorbable versus fast absorbable sutures. Our objective was not to determine the single best combination of suture material and techniques, but to compare the individual components of abdominal closure. SEARCH METHODS: On 8 February 2017 we searched CENTRAL, MEDLINE, Embase, two trials registries, and Science Citation Index. There were no limitations based on language or date of publication. We searched the reference lists of all included studies to identify trials that our searches may have missed. SELECTION CRITERIA: We included randomised controlled trials (RCTs) that compared suture materials or closure techniques, or both, for fascial closure of laparotomy incisions. We excluded trials that compared only types of skin closures, peritoneal closures or use of retention sutures. DATA COLLECTION AND ANALYSIS: We abstracted data and assessed the risk of bias for each trial. We calculated a summary risk ratio (RR) for the outcomes assessed in the review, all of which were dichotomous. We used random-effects modelling, based on the heterogeneity seen throughout the studies and analyses. We completed subgroup analysis planned a priori for each outcome, excluding studies where interventions being compared differed by more than one component, making it impossible to determine which variable impacted on the outcome, or the possibility of a synergistic effect. We completed sensitivity analysis, excluding trials with at least one trait with high risk of bias. We assessed the quality of evidence using the GRADEpro guidelines. MAIN RESULTS: Fifty-five RCTs with a total of 19,174 participants met the inclusion criteria and were included in the meta-analysis. Included studies were heterogeneous in the type of sutures used, methods of closure and patient population. Many of the included studies reported multiple comparisons.For our primary outcome, the proportion of participants who developed incisional hernia at one year or more of follow-up, we did not find evidence that suture absorption (absorbable versus non-absorbable sutures, RR 1.07, 95% CI 0.86 to 1.32, moderate-quality evidence; or slow versus fast absorbable sutures, RR 0.81, 95% CI 0.63 to 1.06, moderate-quality evidence), closure method (mass versus layered, RR 1.92, 95% CI 0.58 to 6.35, very low-quality evidence) or closure technique (continuous versus interrupted, RR 1.01, 95% CI 0.76 to 1.35, moderate-quality evidence) resulted in a difference in the risk of incisional hernia. We did, however, find evidence to suggest that monofilament sutures reduced the risk of incisional hernia when compared with multifilament sutures (RR 0.76, 95% CI 0.59 to 0.98, I2 = 30%, moderate-quality evidence).For our secondary outcomes, we found that none of the interventions reduced the risk of wound infection, whether based on suture absorption (absorbable versus non-absorbable sutures, RR 0.99, 95% CI 0.84 to 1.17, moderate-quality evidence; or slow versus fast absorbable sutures, RR 1.16, 95% CI 0.85 to 1.57, moderate-quality evidence), closure method (mass versus layered, RR 0.93, 95% CI 0.67 to 1.30, low-quality evidence) or closure technique (continuous versus interrupted, RR 1.13, 95% CI 0.96 to 1.34, moderate-quality evidence).Similarily, none of the interventions reduced the risk of wound dehiscence whether based on suture absorption (absorbable versus non-absorbable sutures, RR 0.78, 95% CI 0.55 to 1.10, moderate-quality evidence; or slow versus fast absorbable sutures, RR 1.55, 95% CI 0.92 to 2.61, moderate-quality evidence), closure method (mass versus layered, RR 0.69, 95% CI 0.31 to 1.52, moderate-quality evidence) or closure technique (continuous versus interrupted, RR 1.21, 95% CI 0.90 to 1.64, moderate-quality evidence).Absorbable sutures, compared with non-absorbable sutures (RR 0.49, 95% CI 0.26 to 0.94, low-quality evidence) reduced the risk of sinus or fistula tract formation. None of the other comparisons showed a difference (slow versus fast absorbable sutures, RR 0.88, 95% CI 0.05 to 16.05, very low-quality evidence; mass versus layered, RR 0.49, 95% CI 0.15 to 1.62, low-quality evidence; continuous versus interrupted, RR 1.51, 95% CI 0.64 to 3.61, very low-quality evidence). AUTHORS' CONCLUSIONS: Based on this moderate-quality body of evidence, monofilament sutures may reduce the risk of incisional hernia. Absorbable sutures may also reduce the risk of sinus or fistula tract formation, but this finding is based on low-quality evidence.We had serious concerns about the design or reporting of several of the 55 included trials. The comparator arms in many trials differed by more than one component, making it impossible to attribute differences between groups to any one component. In addition, the patient population included in many of the studies was very heterogeneous. Trials included both emergency and elective cases, different types of disease pathology (e.g. colon surgery, hepatobiliary surgery, etc.) or different types of incisions (e.g. midline, paramedian, subcostal).Consequently, larger, high-quality trials to further address this clinical challenge are warranted. Future studies should ensure that proper randomisation and allocation techniques are performed, wound assessors are blinded, and that the duration of follow-up is adequate. It is important that only one type of intervention is compared between groups. In addition, a homogeneous patient population would allow for a more accurate assessment of the interventions.

Antibiotic treatment for Clostridium difficile-associated diarrhoea in adults.

BACKGROUND: Clostridium difficile (C. difficile) is recognized as a frequent cause of antibiotic-associated diarrhoea and colitis. This review is an update of a previously published Cochrane review. OBJECTIVES: The aim of this review is to investigate the efficacy and safety of antibiotic therapy for C. difficile-associated diarrhoea (CDAD), or C. difficile infection (CDI), being synonymous terms. SEARCH METHODS: We searched MEDLINE, EMBASE, CENTRAL and the Cochrane IBD Group Specialized Trials Register from inception to 26 January 2017. We also searched clinicaltrials.gov and clinicaltrialsregister.eu for ongoing trials. SELECTION CRITERIA: Only randomised controlled trials assessing antibiotic treatment for CDI were included in the review. DATA COLLECTION AND ANALYSIS: Three authors independently assessed abstracts and full text articles for inclusion and extracted data. The risk of bias was independently rated by two authors. For dichotomous outcomes, we calculated the risk ratio (RR) and corresponding 95% confidence interval (95% CI). We pooled data using a fixed-effect model, except where significant heterogeneity was detected, at which time a random-effects model was used. The following outcomes were sought: sustained symptomatic cure (defined as initial symptomatic response and no recurrence of CDI), sustained bacteriologic cure, adverse reactions to the intervention, death and cost. MAIN RESULTS: Twenty-two studies (3215 participants) were included. The majority of studies enrolled patients with mild to moderate CDI who could tolerate oral antibiotics. Sixteen of the included studies excluded patients with severe CDI and few patients with severe CDI were included in the other six studies. Twelve different antibiotics were investigated: vancomycin, metronidazole, fusidic acid, nitazoxanide, teicoplanin, rifampin, rifaximin, bacitracin, cadazolid, LFF517, surotomycin and fidaxomicin. Most of the studies were active comparator studies comparing vancomycin with other antibiotics. One small study compared vancomycin to placebo. There were no other studies that compared antibiotic treatment to a placebo or a 'no treatment' control group. The risk of bias was rated as high for 17 of 22 included studies. Vancomycin was found to be more effective than metronidazole for achieving symptomatic cure. Seventy-two per cent (318/444) of metronidazole patients achieved symptomatic cure compared to 79% (339/428) of vancomycin patients (RR 0.90, 95% CI 0.84 to 0.97; moderate quality evidence). Fidaxomicin was found to be more effective than vancomycin for achieving symptomatic cure. Seventy-one per cent (407/572) of fidaxomicin patients achieved symptomatic cure compared to 61% (361/592) of vancomycin patients (RR 1.17, 95% CI 1.04 to 1.31; moderate quality evidence). Teicoplanin may be more effective than vancomycin for achieving a symptomatic cure. Eightly-seven per cent (48/55) of teicoplanin patients achieved symptomatic cure compared to 73% (40/55) of vancomycin patients (RR 1.21, 95% CI 1.00 to 1.46; very low quality evidence). For other comparisons including the one placebo-controlled study the quality of evidence was low or very low due to imprecision and in many cases high risk of bias because of attrition and lack of blinding. One hundred and forty deaths were reported in the studies, all of which were attributed by study authors to the co-morbidities of the participants that lead to acquiring CDI. Although many other adverse events were reported during therapy, these were attributed to the participants' co-morbidities. The only adverse events directly attributed to study medication were rare nausea and transient elevation of liver enzymes. Recent cost data (July 2016) for a 10 day course of treatment shows that metronidazole 500 mg is the least expensive antibiotic with a cost of USD 13 (Health Warehouse). Vancomycin 125 mg costs USD 1779 (Walgreens for 56 tablets) compared to fidaxomicin 200 mg at USD 3453.83 or more (Optimer Pharmaceuticals) and teicoplanin at approximately USD 83.67 (GBP 71.40, British National Formulary). AUTHORS' CONCLUSIONS: No firm conclusions can be drawn regarding the efficacy of antibiotic treatment in severe CDI as most studies excluded patients with severe disease. The lack of any 'no treatment' control studies does not allow for any conclusions regarding the need for antibiotic treatment in patients with mild CDI beyond withdrawal of the initiating antibiotic. Nonetheless, moderate quality evidence suggests that vancomycin is superior to metronidazole and fidaxomicin is superior to vancomycin. The differences in effectiveness between these antibiotics were not too large and the advantage of metronidazole is its far lower cost compared to the other two antibiotics. The quality of evidence for teicoplanin is very low. Adequately powered studies are needed to determine if teicoplanin performs as well as the other antibiotics. A trial comparing the two cheapest antibiotics, metronidazole and teicoplanin, would be of interest.

Surgery for complete (full-thickness) rectal prolapse in adults.

BACKGROUND: Complete (full-thickness) rectal prolapse is a lifestyle-altering disability that commonly affects older people. The range of surgical methods available to correct the underlying pelvic floor defects in full-thickness rectal prolapse reflects the lack of consensus regarding the best operation. OBJECTIVES: To assess the effects of different surgical repairs for complete (full-thickness) rectal prolapse. SEARCH METHODS: We searched the Cochrane Incontinence Group Specialised Register up to 3 February 2015; it contains trials from the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, MEDLINE in process, ClinicalTrials.gov and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) as well as trials identified through handsearches of journals and conference proceedings. We also searched EMBASE and EMBASE Classic (1947 to February 2015) and PubMed (January 1950 to December 2014), and we specifically handsearched theBritish Journal of Surgery (January 1995 to June 2014), Diseases of the Colon and Rectum (January 1995 to June 2014) and Colorectal Diseases (January 2000 to June 2014), as well as the proceedings of the Association of Coloproctology meetings (January 2000 to December 2014). Finally, we handsearched reference lists of all relevant articles to identify additional trials. SELECTION CRITERIA: All randomised controlled trials (RCTs) of surgery for managing full-thickness rectal prolapse in adults. DATA COLLECTION AND ANALYSIS: Two reviewers independently selected studies from the literature searches, assessed the methodological quality of eligible trials and extracted data. The four primary outcome measures were the number of patients with recurrent rectal prolapse, number of patients with residual mucosal prolapse, number of patients with faecal incontinence and number of patients with constipation. MAIN RESULTS: We included 15 RCTs involving 1007 participants in this third review update. One trial compared abdominal with perineal approaches to surgery, three trials compared fixation methods, three trials looked at the effects of lateral ligament division, one trial compared techniques of rectosigmoidectomy, two trials compared laparoscopic with open surgery, and two trials compared resection with no resection rectopexy. One new trial compared rectopexy versus rectal mobilisation only (no rectopexy), performed with either open or laparoscopic surgery. One new trial compared different techniques used in perineal surgery, and another included three comparisons: abdominal versus perineal surgery, resection versus no resection rectopexy in abdominal surgery and different techniques used in perineal surgery.The heterogeneity of the trial objectives, interventions and outcomes made analysis difficult. Many review objectives were covered by only one or two studies with small numbers of participants. Given these caveats, there is insufficient data to say which of the abdominal and perineal approaches are most effective. There were no detectable differences between the methods used for fixation during rectopexy. Division, rather than preservation, of the lateral ligaments was associated with less recurrent prolapse but more postoperative constipation. Laparoscopic rectopexy was associated with fewer postoperative complications and shorter hospital stay than open rectopexy. Bowel resection during rectopexy was associated with lower rates of constipation. Recurrence of full-thickness prolapse was greater for mobilisation of the rectum only compared with rectopexy. There were no differences in quality of life for patients who underwent the different kinds of prolapse surgery. AUTHORS' CONCLUSIONS: The lack of high quality evidence on different techniques, together with the small sample size of included trials and their methodological weaknesses, severely limit the usefulness of this review for guiding practice. It is impossible to identify or refute clinically important differences between the alternative surgical operations. Longer follow-up with current studies and larger rigorous trials are needed to improve the evidence base and to define the optimum surgical treatment for full-thickness rectal prolapse.

Anal fissure (chronic).

INTRODUCTION: Anal fissures are a common cause of anal pain during, and for 1 to 2 hours after, defecation. The cause is not fully understood, but low intake of dietary fibre may be a risk factor. METHODS AND OUTCOMES: We conducted a systematic review and aimed to answer the following clinical question: What are the effects of surgical treatments for chronic anal fissure? We searched: Medline, Embase, The Cochrane Library, and other important databases up to January 2014 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). RESULTS: We found nine studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. CONCLUSIONS: In this systematic review, we present information relating to the effectiveness and safety of the following interventions: anal advancement flap, anal stretch/dilation, and internal anal sphincterotomy.

Antimicrobial prophylaxis for colorectal surgery.

BACKGROUND: Research shows that administration of prophylactic antibiotics before colorectal surgery prevents postoperative surgical wound infection. The best antibiotic choice, timing of administration and route of administration remain undetermined. OBJECTIVES: To establish the effectiveness of antimicrobial prophylaxis for the prevention of surgical wound infection in patients undergoing colorectal surgery. Specifically to determine:1. whether antimicrobial prophylaxis reduces the risk of surgical wound infection;2. the target spectrum of bacteria (aerobic or anaerobic bacteria, or both);3. the best timing and duration of antibiotic administration;4. the most effective route of antibiotic administration (intravenous, oral or both);5. whether any antibiotic is clearly more effective than the currently recommended gold standard specified in published guidelines;6. whether antibiotics should be given before or after surgery. SEARCH METHODS: For the original review published in 2009 we searched the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE (Ovid) and EMBASE (Ovid). For the update of this review we rewrote the search strategies and extended the search to cover from 1954 for MEDLINE and 1974 for EMBASE up to 7 January 2013. We searched CENTRAL on the same date (Issue 12, 2012). SELECTION CRITERIA: Randomised controlled trials of prophylactic antibiotic use in elective and emergency colorectal surgery, with surgical wound infection as an outcome. DATA COLLECTION AND ANALYSIS: Data were abstracted and reviewed by one review author and checked by another only for the single, dichotomous outcome of surgical wound infection. Quality of evidence was assessed using GRADE methods. MAIN RESULTS: This updated review includes 260 trials and 68 different antibiotics, including 24 cephalosporins and 43,451 participants. Many studies had multiple variables that separated the two study groups; these could not be compared to other studies that tested one antibiotic and had a single variable separating the two groups. We did not consider the risk of bias arising from attrition and lack of blinding of outcome assessors to affect the results for surgical wound infection.Meta-analyses demonstrated a statistically significant difference in postoperative surgical wound infection when prophylactic antibiotics were compared to placebo/no treatment (risk ratio (RR) 0.34, 95% confidence interval (CI) 0.28 to 0.41, high quality evidence). This translates to a reduction in risk from 39% to 13% with prophylactic antibiotics. The slightly higher risk of wound infection with short-term compared with long-term duration antibiotic did not reach statistical significance (RR 1.10, 95% CI 0.93 to 1.30). Similarly risk of would infection was slightly higher with single-dose antibiotics when compared with multiple dose antibiotics, but the results are compatible with benefit and harm (RR 1.30, 95% CI 0.81 to 2.10). Additional aerobic coverage and additional anaerobic coverage both showed statistically significant improvements in surgical wound infection rates (RR 0.44, 95% CI 0.29 to 0.68 and RR 0.47, 95% CI 0.31 to 0.71, respectively), as did combined oral and intravenous antibiotic prophylaxis when compared to intravenous alone (RR 0.56, 95% CI 0.43 to 0.74), or oral alone (RR 0.56, 95% CI 0.40 to 0.76). Comparison of an antibiotic with anaerobic specificity to one with aerobic specificity showed no significant advantage for either one (RR 0.84, 95% CI 0.30 to 2.36). Two small studies compared giving antibiotics before or after surgery and no significant difference in this timing was found (RR 0.67, 95% CI 0.21 to 2.15). Established gold-standard regimens recommended in major guidelines were no less effective than any other antibiotic choice. AUTHORS' CONCLUSIONS: This review has found high quality evidence that antibiotics covering aerobic and anaerobic bacteria delivered orally or intravenously (or both) prior to elective colorectal surgery reduce the risk of surgical wound infection. Our review shows that antibiotics delivered within this framework can reduce the risk of postoperative surgical wound infection by as much as 75%. It is not known whether oral antibiotics would still have these effects when the colon is not empty. This aspect of antibiotic dosing has not been tested. Further research is required to establish the optimal timing and duration of dosing, and the frequency of longer-term adverse effects such as Clostridium difficile pseudomembranous colitis.

Treatment of an initial infection with clostridium difficile in patients with inflammatory bowel disease.

: Although the incidence of Clostridium difficile-associated diarrhea in the general population has increased dramatically over the past decade, an even greater rate of infection exists in patients with inflammatory bowel disease. Susceptibility in this population is likely inherent to the pathophysiology and treatment of these diseases. C. difficile infection can cause serious complications and death. Consequently, early diagnosis and initiation of effective antibacterial therapy is imperative. This article evaluates treatment recommendations for an initial episode of C. difficile infection in patients with inflammatory bowel disease based on the current guidelines and a Cochrane systematic review.

Surgery for faecal incontinence in adults.

BACKGROUND: Faecal incontinence is a debilitating problem with significant medical, social and economic implications. Treatment options include conservative, non-operative interventions (for example pelvic floor muscle training, biofeedback, drugs) and surgical procedures. A surgical procedure may be aimed at correcting an obvious mechanical defect, or augmenting a functionally deficient but structurally intact sphincter complex. OBJECTIVES: To assess the effects of surgical techniques for the treatment of faecal incontinence in adults who do not have rectal prolapse. Our aim was firstly to compare surgical management with non-surgical management and secondly, to compare the various surgical techniques. SEARCH METHODS: Electronic searches of the Cochrane Incontinence Group Specialised Register (searched 6 March 2013), the Cochrane Colorectal Cancer Group Specialised Register (searched 6 March 2013), CENTRAL (2013, issue 1) and EMBASE (1 January 1998 to 6 March 2013) were undertaken. The British Journal of Surgery (1 January 1995 to 6 March 2013), Colorectal Diseases (1 January 2000 to 6 March 2013) and the Diseases of the Colon and Rectum (1 January 1995 to 6 March 2013) were specifically handsearched. The proceedings of the Association of Coloproctology of Great Britain and Ireland annual meetings held from 1999 to 2012 were perused. Reference lists of all relevant articles were searched for further trials. SELECTION CRITERIA: All randomised or quasi-randomised trials of surgery in the management of adult faecal incontinence (other than surgery for rectal prolapse). DATA COLLECTION AND ANALYSIS: Three review authors independently selected studies from the literature, assessed the methodological quality of eligible trials and extracted data. The three primary outcome measures were change or deterioration in incontinence, failure to achieve full continence, and the presence of faecal urgency. MAIN RESULTS: Nine trials were included with a total sample size of 264 participants. Two trials included a group managed non-surgically. One trial compared levatorplasty with anal plug electrostimulation and one compared an artificial bowel sphincter with best supportive care. The artificial bowel sphincter resulted in significant improvements in at least one primary outcome but the numbers were small. The other trial showed no difference in the primary outcome measures.Seven trials compared different surgical interventions. These included anterior levatorplasty versus postanal repair, anterior levatorplasty versus total pelvic floor repair, total pelvic floor versus postanal repair, end to end versus overlap sphincter repair, overlap repair with or without a defunctioning stoma or with or without biofeedback, and total pelvic floor repair versus repair plus internal sphincter plication and neosphincter formation versus total pelvic floor repair. Sacral nerve stimulation and injectables are considered in separate Cochrane reviews. Only one comparison had more than one trial (total pelvic floor versus postanal repair, 44 participants) and no trial showed any difference in primary outcome measures. AUTHORS' CONCLUSIONS: The review is striking for the lack of high quality randomised controlled trials on faecal incontinence surgery that have been carried out in the last 10 years. Those trials that have been carried out have focused on sacral neuromodulation and injectable bulking agents, both reported in separate reviews. The continued small number of relevant trials identified together with their small sample sizes and other methodological weaknesses limit the usefulness of this review for guiding practice. It was impossible to identify or refute clinically important differences between the alternative surgical procedures. Larger rigorous trials are still needed. However, it should be recognised that the optimal treatment regime may be a complex combination of various surgical and non-surgical therapies.

Transparent cap colonoscopy versus standard colonoscopy: a systematic review and meta-analysis.

Due to the increasing demand for colonoscopy, devices to advance examination techniques are highly sought after. Several studies have examined the use of a transparent cap attached to the tip of the colonoscope, but the data are inconsistent. The aim of our study was to establish whether transparent cap colonoscopy is beneficial in the improvement of caecal intubation rate, time and polyp detection. We undertook a systematic review and meta-analysis in the form of a Cochrane review to evaluate these outcomes. We included fourteen randomised controlled trials that have been published to date. Transparent cap colonoscopy demonstrates a significant reduction in caecal intubation time, by an average of 48 s, when compared to standard colonoscopy. There was no significant difference in caecal intubation rate or polyp detection between the two groups. Despite a significant difference in caecal intubation time, the clinical significance of the transparent cap remains to be seen. We believe further research is needed to investigate this adjunct.

Transparent cap colonoscopy versus standard colonoscopy to improve caecal intubation.

BACKGROUND: Colonoscopy is considered the gold-standard investigation for screening and diagnosis of colorectal cancer. It is also becoming increasingly desirable for assessment, management, diagnosis and follow-up of other colorectal diseases, such as inflammatory bowel diseases and acute diverticulitis. Hence, due to the increasing demand for colonoscopy, devices to advance examination techniques are highly sought-after and the colonoscope with the transparent cap could be one of these. OBJECTIVES: To identify and review all relevant data in order to determine whether colonoscopy with a transparent cap is a more effective diagnostic tool than colonoscopy. SEARCH METHODS: We searched the MEDLINE, EMBASE and CINAHL databases, and the Cochrane Central Register of Controlled Trials for all randomised controlled trials (RCTs) comparing the use of colonoscopy with a transparent cap with standard colonoscopy. SELECTION CRITERIA: Studies were included if they were randomised controlled trials which compared the use of colonoscopy with a transparent cap with standard colonoscopy. DATA COLLECTION AND ANALYSIS: Data on study methods, participants, interventions used and outcomes measured was extracted from each study. Data was entered into the Cochrane Review Manager software (RevMan 5.0, 2008) and analysed using Cochrane MetaView. MAIN RESULTS: In the present meta-analysis, we considered 14 randomised controlled trials so far published. The findings of our work indicate that colonoscopy with transparent cap has a faster caecal intubation time when compared with standard colonoscopy. Reviewing studies individually would also seem to favour colonoscopy with transparent cap for polyp detection rate and pain during procedure but due to lack of comparable data meta-analysis was not feasible. AUTHORS' CONCLUSIONS: This review suggests that a transparent cap on the end of the colonoscope may give a marginally faster caecal intubation time compared with standard colonoscopy. It also suggests that there is a better polyp detection rate and less pain with the cap. However, the authors feel that further randomised controlled trials in this area would provide more clinically significant information on this adjunct to colonoscopy.

Pregabalin for chronic prostatitis.

BACKGROUND: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a condition that is detrimental to the quality of life of men. Evidence suggests that it may have a neuropathic origin and therefore medications such as pregabalin might have a role in the controlling of symptoms. OBJECTIVES: The primary objective was to compare pregabalin to other modalities of pain relief to alleviate men's symptoms of CP/CPPS.The secondary objective was to assess the safety and effectiveness of pregabalin to improve various individual symptoms consistent with CP/CPPS. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (1966 to May 2012), EMBASE (1980 to May 2012), CINAHL, clinicaltrials.gov, Google Scholar, and reference lists of articles and abstracts from conference proceedings, without language restriction for pregabalin treatment of Class III prostatitis and CP/CPPS. SELECTION CRITERIA: Randomized controlled trials (RCTs) comparing pregabalin to placebo or other types of analgesics for the management of patients with CP/CPPS were included. Patients with known causes of pain/discomfort were excluded. DATA COLLECTION AND ANALYSIS: Only one RCT was included. The trial compared pregabalin to placebo for patients who had CP/CPPS. MAIN RESULTS: For men who responded clinically (≥ 6-point improvement), there was no difference between the pregabalin (103/218; 47.2%) and placebo (38/106; 35.8%) arms (risk ratio (RR) 1.32; 95% CI 0.99 to 1.76). There was less pain with a higher point improvement in the pregabalin group compared to the placebo group (4.2 points versus 1.7 points, respectively; mean difference (MD) -2.3 points; 95% CI -4.0 to -0.7 points).Though 59% (191/324) of the patients developed side effects, no serious effects were experienced. There were significantly more neurologic side effects in the pregabalin group compared to the placebo group (38.5% (84/218) versus 22.6% (24/106), respectively; RR 1.7; 95% CI 1.15 to 2.51), and less pain in the pregabalin group than in the placebo group (17.4% (38/218) versus 33.3% (35/106), respectively; RR 0.53; 95% CI 0.36 to 0.78). However, no significant differences were seen between the pregabalin and placebo groups with regards to gastrointestinal disturbances (18.3% (40/218) versus 18.9% (20/106), respectively; RR 0.97; 95% CI 0.60 to 1.58), ocular/visual symptoms (6.9% (15/218) versus 2.8% (3/106), respectively; RR 2.43; 95% CI 0.72 to 8.22), and renal/genitourinary symptoms (5.5% (12/218) versus 1.9% (2/106), respectively; RR 3.03; 95% CI 0.67 to 13.79). AUTHORS' CONCLUSIONS: There is evidence from one RCT that pregabalin does not improve CP/CPPS symptoms and causes adverse effects in a large percentage of men. However, research is required to assess further whether pregabalin has a role in patients with CP/CPPS for symptom control.

Non surgical therapy for anal fissure.

BACKGROUND: Because of the disability associated with surgery for anal fissure and the risk of incontinence, medical alternatives for surgery have been sought. Most recently, pharmacologic methods that relax the anal smooth muscle, to accomplish reversibly what occurs in surgery, have been used to obtain fissure healing. OBJECTIVES: To assess the efficacy and morbidity of various medical therapies for anal fissure. SEARCH METHODS: Search terms include "anal fissure randomized". Timing from 1966 to August 2010. Further details of the search below. SELECTION CRITERIA: Studies in which participants were randomized to a non-surgical therapy for anal fissure. Comparison groups may include an operative procedure, an alternate medical therapy or placebo. Chronic fissure, acute fissure and fissure in children are included in the review. Atypical fissures associated with inflammatory bowel disease or cancer or anal infection are excluded. DATA COLLECTION AND ANALYSIS: Data were abstracted from published reports and meeting abstracts, assessing method of randomization, blinding, "intention to treat" and drop-outs, therapies, supportive measures (applied to both groups), dosing and frequency and cross-overs. Dichotomous outcome measures included Non-healing of the fissure (a combination of persistence and recurrence), and Adverse events (including incontinence, headache, infection, anaphylaxis). Continuous outcome measures included measures of pain relief and anorectal manometry. MAIN RESULTS: In this update 23 studies including 1236 participants is added to the 54 studies and 3904 participants in the 2008 publication, however 2 studies were from the last version reclassified as un included, so the final number of participants is 5031.49 different comparisons of the ability of medical therapies to heal anal fissure have been reported in 75 RCTs. Seventeen agents were used (nitroglycerin ointment (GTN), isosorbide mono & dinitrate, Botulinum toxin (Botox), diltiazem, nifedipine (Calcium channel blockers or CCBs), hydrocortisone, lignocaine, bran, minoxidil, indoramin, clove oil, L-arginine, sitz baths, sildenafil, "healer cream" and placebo) as well as Sitz baths, anal dilators and surgical sphincterotomy. GTN was found to be marginally but significantly better than placebo in healing anal fissure (48.9% vs. 35.5%, p < 0.0009), but late recurrence of fissure was common, in the range of 50% of those initially cured. Botox and CCBs were equivalent to GTN in efficacy with fewer adverse events. No medical therapy came close to the efficacy of surgical sphincterotomy, though none of the medical therapies in these RCTs were associated with the risk of incontinence. AUTHORS' CONCLUSIONS: Medical therapy for chronic anal fissure, currently consisting of topical glyceryl trinitrate, botulinum toxin injection or the topical calcium channel blockers nifedipine or diltiazem in acute and chronic fissure and fissure in children may be applied with a chance of cure that is marginally better than placebo. For chronic fissure in adults all medical therapies are far less effective than surgery. A few of the newer agents investigated show promise based only upon single studies (clove oil, sildenifil and a "healer cream") but lack comparison to more established medications.

Antimicrobial prophylaxis for colorectal surgery

BACKGROUND: Research shows that administration of prophylactic antibiotics before colorectal surgery prevents postoperative surgical wound infection (SWI). The best antibiotic choice, timing of administration and route of administration remain undetermined. OBJECTIVES: To establish the effectiveness of antimicrobial prophylaxis for the prevention of SWI in patients undergoing colorectal surgery: specifically to determine, 1 Whether it reduces risk of SWI. 2 The target spectrum/a of bacteria (aerobic and/or anaerobic). 3 The best timing and duration of antibiotic administration. 4 The most effective route of antibiotic administration (intravenous, oral or both). 5 Whether any antibiotic is clearly more effective than the currently recommended gold standard. CRITERIA FOR CONSIDERING STUDIES FOR THIS REVIEW: Central, Medline, and Embase, were searched from January, 1980 to December, 2007. SELECTION CRITERIA: Randomized controlled trials of prophylactic antibiotic use in elective and emergency colorectal surgery, with SWI as an outcome. DATA COLLECTION AND ANALYSIS: Data were abstracted and reviewed by three authors for only the single, dichotomous outcome of SWI. MAIN RESULTS: The review included 182 trials (30,880 participants), and 50 different antibiotics, including 17 cephalosporins. Many studies had multiple variables that separated the two study groups and could not be compared to other studies that tested one antibiotic and had a single variable separating the two groups. Meta-analyses demonstrated a statistically significant difference in postoperative SWI when prophylactic antibiotics were compared to placebo/no treatment [relative risk (RR) 0.30, 95% confidence intervals (CI) 0.22 to 0.41}. No statistically significant differences were shown when comparing short- and long-term duration of prophylaxis (RR 1.06, 95% CI 0.89 to 1.27); or single dose versus multiple dose antibiotics (RR 1.17, 95% CI 0.67 to 2.05). Additional aerobic coverage and additional anaerobic coverage both showed statistically significant improvements in SWI rates (RR 0.41, 95% CI 0.23 to 0.71 and RR 0.55, 95% CI 0.35 to 0.85, respectively); as did combined oral and intravenous antibiotic prophylaxis when compared to intravenous alone (RR 0.55, 95% CI 0.41 to 0.74), or oral alone (RR 0.34, 95% CI 0.13 to 0.87). Established gold standard regimens were no less effective than any other antibiotic choice. AUTHORS' CONCLUSIONS: Antibiotics covering aerobic and aerobic bacteria should be delivered orally and intravenously prior to colorectal surgery. Antibiotics delivered within this framework will reduce the risk of postoperative SWI by at least 75%. Further research is required to establish the optimal timing and duration of dosing, and frequency of longer-term adverse effects such as Clostridium difficile pseudomembranous colitis.

Operative procedures for fissure in ano.

BACKGROUND: Reports of direct comparisons between operative techniques for anal fissure are variable in their results. These reports are either subject to selection bias (in non-randomized studies) or observer bias (in all studies) or have inadequate numbers of patients enrolled to answer the question of efficacy. OBJECTIVES: To determine the best technique for fissure surgery. SEARCH METHODS: The Cochrane Central Register of Controlled Trials and MEDLINE (1965-2011), Medline (Pubmed) and Embase were searched March to 2011. The list of cited references in all included reports and several study authors also were helpful in finding additional comparative studies.A total of four new trials were included in this update of the review. SELECTION CRITERIA: All reports in which there was a direct comparison between at least two operative techniques were reviewed and when more than one report existed for any given pair, that report was included. All studies must also be randomised. If crude data were not presented in the report, the authors were contacted and crude data obtained. DATA COLLECTION AND ANALYSIS: The two most commonly used end points in all reported studies were treatment failure and post-operative incontinence both to flatus and faeces. These are the only two endpoints included in the meta-analysis. MAIN RESULTS: Four trials, encompassing 406 patients were included in this update, with now a total of 2056 patients in the review from 27 studies that describe and analyze 13 different operative procedures. These operative techniques used by these studies include closed lateral sphincterotomy, open lateral internal sphincterotomy, anal stretch, balloon dilation, wound closure, perineoplasty, length of sphincterotomy and fissurectomy. Two new procedures in the update, similar to anal stretch were described- sphincterolysis and controlled intermittent anal dilatation. A new comparison was described, comparing the effects of unilateral internal sphincterotomy and bilateral internal sphincterotomy.Manual Anal stretch has a higher risk of fissure persistence than internal sphincterotomy and also a significantly higher risk of minor incontinence than sphincterotomy. The combined analyses of open versus closed partial lateral internal sphincterotomy show little difference between the two procedures both in fissure persistence and risk of incontinence Unilateral internal sphincterotomy was shown to be more likely to result in treatment failure compared to bilateral internal sphincterotomy, but there is no significant difference in the risk of incontinence.Sphincterotomy was less likely to result in treatment failure when compared to fissurectomy, but there was no significant difference when considering post-operative incontinence.When comparing sphincterotomy to sphincterolysis, there was no significant difference between the two procedures both in treatment failure and risk of incontinence; the same is the case when comparing sphincterotomy with controlled anal dilation. AUTHORS' CONCLUSIONS: Manual anal stretch should probably be abandoned in the treatment of chronic anal fissure in adults. For those patients requiring surgery for anal fissure, open and closed partial lateral internal sphincterotomy appear to be equally efficacious. More data are needed to assess the effectiveness of posterior internal sphincterotomy, anterior levatorplasty, wound suture or papilla excision. Bilateral internal sphincterotomy shows promise, but needs further research into its efficacy.

Antibiotic treatment for Clostridium difficile-associated diarrhea in adults.

BACKGROUND: Clostridium difficile is recognized as a frequent cause of antibiotic-associated diarrhea and colitis. OBJECTIVES: The aim of this review is to investigate the efficacy of antibiotic therapy for C. difficile-associated diarrhea (CDAD). SEARCH STRATEGY: MEDLINE (1966 to March 24, 2010), EMBASE (1980 to March 24, 2010), Cochrane Central Register of Controlled Trials and the Cochrane IBD/FBD Review Group Specialized Trials Register were searched using the following search terms: "pseudomembranous colitis and randomized trial"; "Clostridium difficile and randomized trial"; "antibiotic associated diarrhea and randomized trial". SELECTION CRITERIA: Only randomized, controlled trials assessing antibiotic treatment for CDAD were included in the review. The following outcomes were sought: initial resolution of diarrhea; initial conversion of stool to cytotoxin and/or culture negative; recurrence of diarrhea; recurrence of fecal evidence of CDAD; patient response to cessation of prior antibiotic therapy; emergent surgery; and death. DATA COLLECTION AND ANALYSIS: Three authors independently assessed abstracts and full text articles for inclusion. The risk of bias was independently rated by two authors. For dichotomous outcomes, relative risks (RR) and 95% confidence intervals (CI) were derived from each study and summary statistics obtained when appropriate, using a fixed effects model, except where significant heterogeneity was detected, at which time a random effects model was used. MAIN RESULTS: Fifteen studies (total of 1152 participants) with CDAD were included. Nine different antibiotics were investigated: vancomycin, metronidazole, fusidic acid, nitazoxanide, teicoplanin, rifampin, rifaximin, bacitracin and fidaxomicin (OPT-80). Most of the studies were active comparator studies comparing vancomycin with other antibiotics. The risk of bias was rated as high for 12 of 15 included studies. Patients with severe CDAD were often excluded from the included studies. In the only placebo-controlled trial vancomycin was found to be superior to placebo for treatment of CDAD for initial symptomatic cure. Initial symptomatic cure was achieved in 41% of vancomycin patients compared to 4% of placebo patients (1 study; 44 patients; RR 9.00; 95% CI 1.24 to 65.16). Vancomycin was significantly superior to placebo for initial bacteriologic response. Initial bacteriologic response was achieved in 45% of vancomycin patients compared to 4% of placebo patients (1 study; 44 patients; RR 10.00; 95% CI 1.40 to 71.62). The results of this study should be interpreted with caution due to the small number of patients and high risk of bias. No statistically significant differences in efficacy were found between vancomycin and metronidazole, vancomycin and fusidic acid, vancomycin and nitazoxanide, or vancomycin and rifaximin. No statistically significant differences in efficacy were found between metronidazole and nitazoxanide or metronidazole and fusidic acid. Vancomycin was significantly superior to bacitracin for initial bacteriologic response. Initial bacteriologic response was achieved in 48% of vancomycin patients compared to 25% of bacitracin patients (2 studies; 104 patients; RR 0.52; 95% CI 0.31 to 0.86). Teicoplanin, an antibiotic of limited availability and great cost, was significantly superior to vancomycin for initial bacteriologic response and cure. Initial bacteriologic response was achieved in 62% of vancomycin patients compared to 87% of teicoplanin patients (2 studies; 110 patients; RR 1.43; 95% CI 1.14 to 1.81). Bacteriologic cure was achieved in 45% of vancomycin patients compared to 82% of teicoplanin patients (2 studies; 110 patients; RR 1.82; 95% CI 1.19 to 2.78). These results should be interpreted with caution due to the small number of patients and the high risk of bias in the two studies in the pooled analysis. Teicoplanin was significantly superior to metronidazole for initial bacteriologic response. Initial bacteriologic response was achieved in 71% of metronidazole patients compared to 93% of teicoplanin patients (1 study; 59 patients; RR 0.76; 95% CI 0.60 to 0.98). This result should be interpreted with caution due to the small number of patients and high risk of bias in the study. Only one study investigated synergistic antibiotic combination, metronidazole and rifampin, and no advantage was demonstrated for the drug combination. This result should be interpreted with caution due to the small number of patients and high risk of bias in the study. Adverse events including surgery and death occurred infrequently in the included studies. There was a total of 18 deaths among 1152 patients in this systematic review. Among the studies that commented on the cause of mortality the deaths were attributed to underlying disease rather than CDAD or antibiotic treatment. One study reported a partial colectomy after failed CDAD treatment. AUTHORS' CONCLUSIONS: Current evidence leads to uncertainty whether mild CDAD needs to be treated. The studies provide little evidence for antibiotic treatment of severe CDAD as many studies excluded these patients. Considering the two goals of therapy: improvement of the patient's clinical condition and prevention of spread of C. difficile infection to other patients, one should choose the antibiotic that brings both symptomatic cure and bacteriologic cure. A recommendation to achieve these goals cannot be made because of the small numbers of patients in the included studies and the high risk of bias in these studies, especially related to dropouts. Most of the active comparator studies found no statistically significant difference in efficacy between vancomycin and other antibiotics including metronidazole, fusidic acid, nitazoxanide or rifaximin. Teicoplanin may be an attractive choice but for its limited availability (Teicoplanin is not available in the USA) and great cost relative to the other options. More research of antibiotic treatment and other treatment modalities of CDAD is required.