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Aim This manuscript provides the introduction and detailed methodology used in subsequent reviews to assess the outcomes of surgical interventions with the primary intent of treating chronic constipation in adults and to develop recommendations for practice. Method PRISMA guidance was adhered to throughout. A literature search was performed in public databases between January 1960 and February 2016. Studies that fulfilled strictly-defined PICOS (patients, interventions, controls, outcome, and study design) criteria were included. The process involved two groups of participants: (i): 'a clinical guidance group' of 18 UK experts (including junior support) who performed the systematic reviews and produced summary evidence statements ( SES) based strictly on data synthesis in each review. The same group then produced prototype graded practice recommendations ( GPRs) based on coalescence of SES and expert opinion; (ii): a European Consensus group of 18 ESCP (European Society of Coloproctology) nominated experts from nine European countries evaluated the appropriateness of each prototype GPR based on published RAND/ UCLA methodology. Results An overview of the search results is provided in this manuscript. A total of 156 studies from 307 full text articles (from 2551 initially screened records) were included, providing data on procedures characterized by: (i) colonic resection ( n = 40); (ii) rectal suspension ( n = 18); (iii) rectal wall excision ( n = 44); (iv) rectovaginal septum reinforcement ( n = 47); (v) sacral nerve stimulation ( n = 7). The overall quality of evidence was poor with 113/156 (72.4%) studies providing only Oxford level IV evidence. The best evidence was extracted for rectal excisional procedures, where the majority of studies were Oxford level I or II. The five subsequent reviews provide a total of 99 SES (reflecting perioperative variables, efficacy, harms and prognostic variables) that contributed to 100 prototype GPRs covering patient selection, procedural considerations and patient counselling. The final manuscript details the 85/100 GPRs that were deemed appropriate by European Consensus (remaining 15 were all uncertain) and future research recommendations. Conclusion This manuscript and the following 6 papers suggest that the evidence base for surgical management of chronic constipation is currently poor although some expert consensus exists on best practice. Further studies are required to inform future commissioning of treatments and of research funding. [ABSTRACT FROM AUTHOR]

Aim This manuscript forms the final of seven that address the surgical management of chronic constipation ( CC) in adults. The content coalesces results from the five systematic reviews that precede it and of the European Consensus process to derive graded practice recommendations ( GPR). Methods Summary of review data, development of GPR and future research recommendations as outlined in detail in the 'introduction and methods' paper. Results The overall quality of data in the five reviews was poor with 113/156(72.4%) of included studies providing only level IV evidence and only four included level I RCTs. Coalescence of data from the five procedural classes revealed that few firm conclusions could be drawn regarding procedural choice or patient selection: no single procedure dominated in addressing dynamic structural abnormalities of the anorectum and pelvic floor with each having similar overall efficacy. Of one hundred 'prototype' GPRs developed by the clinical guideline group, 85/100 were deemed 'appropriate' based on the independent scoring of a panel of 18 European experts and use of RAND- UCLA consensus methodology. The remaining 15 were all deemed uncertain. Future research recommendations included some potential RCTs but also a strong emphasis on delivery of large multinational high-quality prospective cohort studies. Conclusion While the evidence base for surgery in CC is poor, the widespread European consensus for GPRs is encouraging. Professional bodies have the opportunity to build on this work by supporting the efforts of their membership to help convert the documented recommendations into clinical guidelines. [ABSTRACT FROM AUTHOR]

Aim Permacol™ collagen paste (Permacol paste) is a new option for the treatment of anorectal fistula. It functions by filling the fistula tract with an acellular crosslinked porcine dermal collagen matrix suspension. The MASERATI 100 study group was set up to evaluate the clinical outcome of Permacol paste in the treatment of anorectal fistula. This paper reports the results from the initial 30 patients enrolled in the MASERATI 100 prospective, observational clinical trial. Method Patients ( N = 30) with anal fistula presenting to 10 European academic surgical units were treated with a sphincter-preserving technique using Permacol paste. Fistula healing was assessed at 1, 3, 6 and 12 months after treatment, with the primary end-point of fistula healing at 6 months post-surgery. Faecal continence and patient satisfaction were recorded at each follow-up visit and adverse events were monitored throughout the follow-up. Results Of the 28 patients with data at 6 months post-surgery, 15 (54%) were healed, and the healing rate was maintained at 12 months. Healing after treatment with Permacol paste was similar for intersphincteric to transsphincteric fistulae and primary or recurrent fistulae. Only one patient exhibited an adverse event (perianal abscess) that was possibly related to the treatment. At the last outpatient visit, over 60% of patients were satisfied or very satisfied with the operation. Conclusion Permacol paste is shown to be effective in treating primary and recurrent cryptoglandular anorectal fistula with minimal unwanted side effects. [ABSTRACT FROM AUTHOR]

Objective The aim of this paper was to analyse the results of treatment of anal fistulas retrospectively. Methods Between 1992 and 2004, 407 patients were operated on for perianal fistula. In the follow-up period, 107 patients were lost, so 300 patients were analysed in the study. The mean follow-up time was 4.2 years. Analysed parameters included: types of surgical procedures in different kinds of fistulas and postoperative complications. Various types of surgical procedures and their effectiveness were described. Late results were assessed taking into account healing time, duration of sick leave, recurrence rate and incidence of anal sphincter dysfunction. Severity of gas and stool incontinence was assessed according to the Cleveland Clinic Incontinence Score. Results In our study, subcutaneous fistula was diagnosed in 23.3%, inter-sphincteric in 18%, trans-sphincteric in 37.7%, supra-sphincteric in 16% and extra-sphincteric in 5% of patients. Single-tract fistulas were present in 88.7% and multi-tract fistulas were present in 11.3%. Overall, 242 patients had primary fistulas and 58 patients had recurrent fistulas. The most frequently performed procedures were cutting seton (139 patients) and radical fistulectomy (104 patients). Recurrent fistulas developed in 14.3%. Postoperative gas and/or stool incontinence was noticed in 10.7%. The recurrence rate was 5.4% in patients with primary fistula and in 51.7% patients presenting with a recurrent fistula. Gas and stool incontinence developed in 3.7% of patients with primary fistulas and in 39.7% of patients presenting with recurrent fistulas. Recurrence rate was 12% in the patients of single-tract fistulas and 32.4% in the patients of multi-tract fistulas. Postoperative gas and/or stool incontinence occurred in 8.3% of patients of single-tract fistulas and in 29.4% of patients of multi-tract fistulas. Conclusions The complication rate was 10-fold higher in patients presenting with a recurrent fistula than in those with primary fistulas and threefold higher in patients with multi-tract fistulas than in those with single-tract fistulas. [ABSTRACT FROM AUTHOR]