Evaluating the risk factors for the development of benign disorders of defaecation: a surgical perspective.

PURPOSE: There remains uncertainty as to which risk factors are important for the development of defaecatory problems as a result of heterogeneity of published evidence. Understanding the impact of risk factors may be important in selecting targets for disease prevention or reversal. The aim of this study was to identify and evaluate risk factors for faecal incontinence and chronic constipation. METHODS: Risk factors for chronic constipation and faecal incontinence were long-listed from scientific literature, then anonymously evaluated (by 50 predominantly colorectal surgical experts from the UK Pelvic Floor Society) using a Delphi technique. Each risk factor was rated as independent, a co-factor, or not a risk factor. Independent risk factors were rated between 1 (not important) and 10 (critically important) with mean (± standard deviation) calculated. RESULTS: Thirty-eight risk factors for chronic constipation were evaluated. Eighteen were classed as independent and 16 as co-factors. Opioid analgesia (7.87 ± 2.05), eating disorders (7.80 ± 1.72), and history of abuse (7.70 ± 1.89) were scored as most important independent risk factors. Female sex (6.60 ± 2.02) was considered an independent risk factor but increasing age was rated a co-factor. Thirty-three risk factors for faecal incontinence were evaluated. Twenty were classed as independent and eight as co-factors. Third- or fourth-degree tear (8.88 ± 1.57), instrumental delivery (8.47 ± 1.58), and grand multiparity (8.00 ± 1.63) were rated most important. Increasing age (7.41 ± 2.14) and female sex (7.58 ± 2.05) were both considered independent risk factors. CONCLUSIONS: Several risk factors for chronic constipation and faecal incontinence were selected by Delphi approach. These factors will feed forward into Bayesian models of disease prediction that combine data and expert knowledge.

Stepped-wedge randomized controlled trial of laparoscopic ventral mesh rectopexy in adults with chronic constipation.

BACKGROUND: The effectiveness of laparoscopic ventral mesh rectopexy (LVMR) in patients with defecatory disorders secondary to internal rectal prolapse is poorly evidenced. A UK-based multicenter randomized controlled trial was designed to determine the clinical efficacy of LVMR compared to controls at medium-term follow-up. METHODS: The randomized controlled trial was conducted from March 1, 2015 TO January 31, 2019. A stepped-wedge RCT design permitted observer-masked data comparisons between patients awaiting LVMR (controls) with those who had undergone surgery. Adult participants with radiologically confirmed IRP refractory to conservative treatment were randomized to three arms with different delays before surgery. Efficacy outcome data were collected at equally stepped time points (12, 24, 36, 48, 60, and 72 weeks). Clinical efficacy of LVMR compared to controls was defined as ≥ 1.0-point reduction in Patient Assessment of Constipation-Quality of Life and/or Symptoms (PAC-QOL and/or PAC-SYM) scores at 24 weeks. Secondary outcome measures included 14-day diary data, the Generalized Anxiety Disorder scale (GAD-7), the Patient Health Questionnaire-9 (PHQ-9), St Marks incontinence score, the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12), the chronic constipation Behavioral Response to Illness Questionnaire (CC-BRQ), and the Brief Illness Perception Questionnaire (BIPQ). RESULTS: Of a calculated sample size of 114, only 28 patients (100% female) were randomized from 6 institutions (due mainly to national pause on mesh-related surgery). Nine were assigned to the T0 arm, 10 to T12, and 9 to T24. There were no substantial differences in baseline characteristics between the three arms. Compared to baseline, significant reduction (improvement) in PAC-QOL and PAC-SYM scores were observed at 24 weeks post-surgery (- 1.09 [95% CI - 1.76, - 0.41], p = 0.0019, and - 0.92 [- 1.52, - 0.32], p = 0.0029, respectively) in the 19 patients available for analysis (9 were excluded for dropout [n = 2] or missing primary outcome [n = 7]). There was a clinically significant long-term reduction in PAC-QOL scores (- 1.38 [- 2.94, 0.19], p = 0.0840 at 72 weeks). Statistically significant improvements in PAC-SYM scores persisted to 72 weeks (- 1.51 [- 2.87, - 0.16], p = 0.0289). Compared to baseline, no differences were found in secondary outcomes, except for significant improvements at 24 and 48 weeks on CC-BRQ avoidance behavior (- 14.3 [95% CI - 23.3, - 5.4], and - 0.92 [- 1.52, - 0.32], respectively), CC-BRQ safety behavior (- 13.7 [95% CI - 20.5, - 7.0], and - 13.0 [- 19.8, - 6.1], respectively), and BIPQ negative perceptions (- 16.3 [95% CI - 23.5, - 9.0], and - 10.5 [- 17.9, - 3.2], respectively). CONCLUSIONS: With the caveat of under-powering due to poor recruitment, the study presents the first randomized trial evidence of short-term benefit of LVMR for internal rectal prolapse. TRIAL REGISTRATION: ISRCTN Registry (ISRCTN11747152).

Epidemiological trends in surgery for rectal prolapse in England 2001-2012: an adult hospital population-based study.

AIM: To analyse trends in admission and surgery for rectal prolapse in adults in England between 2001 and 2012 as well as prolapse reoperation rates. METHOD: Analysis of data derived from a comparative longitudinal population-based cohort study using Hospital Episode Statistics (HES). RESULTS: During the study period, a total of 25 238 adults, of median age 73 [interquartile range (IQR: 58-83] years, underwent a total of 29 379 operations for rectal prolapse (mean: 2662 per annum). The female to male ratio of this group of patients was 7:1. Median length of hospital stay was 3 (IQR: 1-7) days with an overall in-hospital mortality rate of 0.9%. Total number of admissions (4950 in 2001/2002 vs 8927 in 2011/2012) and of patients undergoing prolapse surgery (2230 in 2001/2002 vs 2808 in 2011/2012) significantly increased over the study period (P < 0.001 for trends). The overall increase in prolapse surgery (of 33% overall and of 44% for elective procedures) was dwarfed by an increase in popularity of laparoscopic surgery (of 15-fold). Overall prolapse reoperation rate was 12.7%. The lowest recurrence rate was observed for elective open resection (9.1%) but this had the highest mortality (1.9%). Laparoscopic and perineal fixations were also associated with low reoperation rates (< 11%) and the lowest mortality rates, of 0.3%, when these procedures were elective. These data refute a trend towards subspecialization (by surgeon or hospital) during the study period. CONCLUSION: Admissions for rectal prolapse increased in England between 2001 and 2012, together with increases in rectal prolapse surgery. Surgical decision making has changed over this period and may be reflected in outcome.

Botulinum toxin type A for the treatment of dyssynergic defaecation in adults: a systematic review.

AIM: Dyssynergic defaecation (DD) is characterized by inappropriate coordination of the pelvic floor muscles during defaecation, resulting in impaired stool expulsion. The mainstay of treatment is biofeedback and alternative therapies are limited in those who do not respond. This systematic review evaluated botulinum toxin type A injection (BTXA) as a treatment option for dyssynergia. METHODS: PubMed, Embase and Cochrane Central Register of Controlled Trials were searched for studies evaluating adult patients with DD treated with BTXA injection into the puborectalis and/or external anal sphincter. All study designs, except case reports, were included in the review with no language restriction. Studies limited to patients with specific neurological diagnoses or with a follow-up period under 1 month were excluded. Study selection, assessment and data extraction were performed by two reviewers and results were synthesized narratively. RESULTS: Eleven studies (three randomized control trials) involving 248 participants were included. All studies used the transanal approach to deliver the injection, most commonly at the 3 and 9 o'clock positions using digital palpation for guidance. The most commonly used patient position was left lateral, and most studies did not use any anaesthesia. The dose of BTXA varied (Botox 12-100 units, Dysport 100-500 units), and outcomes measured were heterogeneous (global rating ± up to five investigations). Symptomatic improvement varied between 29.2% and 100% and adverse effects occurred in 0% to 70%. CONCLUSION: The evidence to support using BTXA for DD is poor and only covers a transanal approach. Future studies should redress these limitations: heterogeneity of design, dose and outcome measures.

Position statement by the Pelvic Floor Society on behalf of the Association of Coloproctology of Great Britain and Ireland on the use of mesh in ventral mesh rectopexy.

The following position statement forms part of a response to the current concerns regarding use of mesh to perform rectal prolapse surgery. It highlights the actions being pursued by the Pelvic Floor Society (TPFS) regarding clinical governance in relation to ventral mesh rectopexy (VMR). The following are summary recommendations. Available evidence suggests that mesh morbidity for VMR is far lower than that seen in transvaginal procedures (the main subject of current concern) and lower than that observed following other abdomino-pelvic procedures for urogenital prolapse, e.g. laparoscopic sacrocolpopexy. VMR should be performed by adequately trained surgeons who work within a multidisciplinary team (MDT) framework. Within this, it is mandatory to discuss all patients considered for surgery at an MDT meeting. Clinical outcomes of surgery and any complications resulting from surgery should be recorded in the TPFS-hosted national database (registry) available for this purpose; in addition, all patients should be considered for entry into ongoing and planned UK/European randomized studies where this is feasible. A move towards accreditation of UK units performing VMR will improve performance and outcomes in the long term. An enhanced programme of training including staged porcine, cadaveric and preceptorship sessions will ensure the competence of surgeons undertaking VMR. Enhanced consent forms and patient information booklets are being developed, and these will help both surgeons and patients. There is weak observational evidence that technical aspects of the procedure can be optimized to reduce morbidity rates. Suture material choice may contribute towards morbidity. The available evidence is insufficient to support the use of one mesh over another (biologic vs synthetic); however, the use of polyester mesh is associated with increased morbidity.

Non-randomized studies should be considered for assessing surgical techniques in rectal prolapse: prospective cohort study.

AIM: Randomized trials comparing surgical techniques for rectal prolapse are not always feasible. We assessed whether non-randomized comparisons of those who have had surgery with those still waiting would be confounding baseline health status. METHOD: This was a prospective cohort study in seven UK hospitals. Participants were ≥ 18 years and listed for surgical interventions of equivalent intensity for rectal prolapse. They were defined as short or long waiters (≤ 18 or > 18 weeks, respectively). Time on the waiting list was compared with baseline comorbidity (Charlson comorbidity index) and change from baseline in health status (EQ-5D-5L) at the time of surgery. RESULTS: In all, 203 patients were analysed. Median (interquartile range) waiting time was 13.7 weeks (8.1, 20.4) varying across sites. Baseline comorbidity was not an important predictor of waiting time. Median Charlson comorbidity index was 2 (0, 3) for short and 1 (0, 3) for long waiters. A change in waiting time by a week was associated with negligible improvement in the EQ-5D-5L index of 0.001 (95% CI -0.000 to 0.003, P = 0.106). CONCLUSION: Negligible change in patient reported health status while on the waiting list and lack of effect of comorbidities in influencing waiting time support the use of non-randomized pre-/post-studies to compare the effects of surgical interventions for rectal prolapse.

Initial experience with SphinKeeper™ intersphincteric implants for faecal incontinence in the UK: a two-centre retrospective clinical audit.

AIM: The SphinKeeper™ artificial bowel sphincter implant is a relatively new surgical technique for the treatment of refractory faecal incontinence. This study presents the first experience in two UK tertiary centres. METHOD: This is a retrospective audit of prospectively collected clinical data in relation to technique, safety, feasibility and short-term effectiveness from patients undergoing surgery from January 2016 to April 2019. Baseline data, intra-operative and postoperative complications, symptoms [using St Mark's incontinence score (SMIS)] and radiological outcomes were analysed. RESULTS: Twenty-seven patients [18 women, median age 57 years (range 27-87)] underwent SphinKeeper. In 30% of the patients, the firing device jammed and not all prostheses were delivered. There were no intra-operative complications and all patients were discharged the same or the following day. SMIS significantly improved from baseline [median -6 points (range -12 to +3); P < 0.00016] with 14/27 (51.9%) patients achieving a 50% reduction in the SMIS score. On postoperative imaging, a median of seven prostheses (range 0-10) were identified with a median of five (range 0-10) optimally placed. There was no relationship between number of well-sited prostheses on postoperative imaging and categorical success based on 50% reduction in SMIS (χ2 test, P = 0.79). CONCLUSION: SphinKeeper appears to be a safe procedure for faecal incontinence. Overall, about 50% patients achieved a meaningful improvement in symptoms. However, clinical benefit was unrelated to the rate of misplaced/migrated implants. This has implications for confidence in proof of mechanism and also the need for technical refinement.

Surgery for constipation: systematic review and practice recommendations: Results I: Colonic resection.

AIM: To assess the outcomes of colectomy in adults with chronic constipation (CC). METHOD: Standardised methods and reporting of benefits and harms were used for all CapaCiTY reviews that closely adhered to PRISMA 2016 guidance. Main conclusions were presented as summary evidence statements (SES) with a summative Oxford Centre for Evidence-Based Medicine (2009) level. RESULTS: Forty articles were identified, providing data on outcomes in 2045 patients. Evidence was derived almost exclusively from observational studies, the majority of which concerned colectomy and ileorectal anastomosis (CIRA) rather than other procedural variations. Average length of stay (LOS) ranged between 7-15 days. Although inconsistent, laparoscopic surgery may be associated with longer mean operating times (210 vs 167 min) and modest decreases in LOS (10-8 days). Complications occurred in approximately 24% of patients. Six (0.4%) procedure-related deaths were observed. Recurrent episodes of small bowel obstruction occurred in about 15% (95%CI: 10-21%) of patients in the long-term, with significant burden of re-hospitalisation and frequent recourse to surgery. Most patients reported a satisfactory or good outcome after colectomy but negative long-term functional outcomes persist in a minority of patients. The influence of resection extent, anastomotic configuration and method of access on complication rates remains uncertain. Available evidence weakly supports selection of patients with an isolated slow-transit phenotype. CONCLUSION: Colectomy for CC may benefit some patients but at the cost of substantial short- and long-term morbidity. Current evidence is insufficient to guide patient or procedural selection.

Use of the Harmonic scalpel for Delorme's procedure.

AIM: There are many surgical techniques that deal with external rectal prolapse but perineal procedures have the advantage of reduced invasiveness. Therefore, despite concerns regarding high recurrence rates, the technique is still used by many surgeons. METHOD: This manuscript and video describe our early clinical experience using the Harmonic scalpel in 11 consecutive patients who underwent a Delorme's procedure for external rectal prolapse. RESULTS: The median age of patients was 76 (range: 30-94) years. There were no intra-operative complications, and the median operative time was 78 min. Intra-operative blood loss was minimal (mean 45 ml; range 20-70 ml). Median length of stay was 2 (range: 0-8) days. Overall morbidity and recurrence were both 18%, with a median follow-up of 15 (range: 1-23) months. Nine patients were operated on by a senior trainee with consultant supervision. CONCLUSION: The advantages of this device are mainly those of ease of mucosal dissection, minimal blood loss and shorter operative time in comparison with published series.

Surgery for constipation: systematic review and practice recommendations: Results IV: Recto-vaginal reinforcement procedures.

AIM: To assess the outcomes of recto-vaginal reinforcement procedures in adults with chronic constipation. METHOD: Standardised methods and reporting of benefits and harms were used for all CapaCiTY reviews that closely adhered to PRISMA 2016 guidance. Main conclusions were presented as summary evidence statements with a summative Oxford Centre for Evidence-Based Medicine (2009) level. RESULTS: Forty-three articles were identified, providing data on outcomes in 3346 patients. Average length of procedures ranged between 20 and 169 min, and length of stay between 1 and 15 days. Complications typically occurred after 7-17% of procedures (range 0-61%). Post-operative bleeding was uncommon (0-4%) as well as haematoma or sepsis (0-2%). Fistulation did not occur in most studies. Two procedure-related deaths were observed for 3209 patients. Although inconsistent, 78% of patients reported a satisfactory or good outcome, with 30-50% experiencing reduced symptoms of straining, incomplete emptying or reduced vaginal digitation. About 17% of patients developed anatomical recurrence. Considering measures of harm and global satisfaction rating scales, there was insufficient evidence to prefer one type of procedure over another. There was no evidence to support better outcomes based on selection of patients with a particular size or grade of rectocoele. CONCLUSION: Evidence supporting recto-vaginal reinforcement procedures is currently derived from observational studies and comparisons, with only one high quality study. Large trials are needed to inform future clinical decision making.

Surgery for constipation: systematic review and practice recommendations: Results V: Sacral Nerve Stimulation.

AIM: To assess the outcomes of sacral nerve stimulation in adults with chronic constipation. METHOD: Standardised methods and reporting of benefits and harms were used for all CapaCiTY reviews that closely adhered to PRISMA 2016 guidance. Main conclusions were presented as summary evidence statements with a summative Oxford Centre for Evidence-Based Medicine (2009) level. RESULTS: Seven articles were identified, providing data on outcomes in 375 patients. Length of procedures and length of stay was not reported. Data on harms were inconsistently reported and heterogeneous, making estimates of harm tentative and imprecise. Morbidity rates ranged between 13 and 34%, with overall device removal rate between 8 and 23%. Although inconsistently reported, pooled treatment success was typically 57-87% for patients receiving permanent implants, although there was significant variation between studies. Patient selection was inconsistently documented. No conclusions could be drawn regarding particular phenotypes that responded favourably or unfavourably to sacral nerve stimulation. CONCLUSION: Evidence supporting sacral nerve stimulation is derived from poor quality studies. Three methodologically robust trials are have reported since this review and all have all urged greater caution.

Surgery for constipation: systematic review and practice recommendations: Results II: Hitching procedures for the rectum (rectal suspension).

AIM: To assess the outcomes of rectal suspension procedures (forms of rectopexy) in adults with chronic constipation. METHOD: Standardised methods and reporting of benefits and harms were used for all CapaCiTY reviews that closely adhered to PRISMA 2016 guidance. Main conclusions were presented as summary evidence statements with a summative Oxford Centre for Evidence-Based Medicine (2009) level. RESULTS: Eighteen articles were identified, providing data on outcomes in 1238 patients. All studies reported only on laparoscopic approaches. Length of procedures ranged between 1.5 to 3.5 h, and length of stay between 4 to 5 days. Data on harms were inconsistently reported and heterogeneous, making estimates of harm tentative and imprecise. Morbidity rates ranged between 5-15%, with mesh complications accounting for 0.5% of patients overall. No mortality was reported after any procedures in a total of 1044 patients. Although inconsistently reported, good or satisfactory outcome occurred in 83% (74-91%) of patients; 86% (20-97%) of patients reported improvements in constipation after laparoscopic ventral mesh rectopexy (LVMR). About 2-7% of patients developed anatomical recurrence. Patient selection was inconsistently documented. As most common indication, high grade rectal intussusception was corrected in 80-100% of cases after robotic or LVMR. Healing of prolapse-associated solitary rectal ulcer syndrome occurred in around 80% of patients after LVMR. CONCLUSION: Evidence supporting rectal suspension procedures is currently derived from poor quality studies. Methodologically robust trials are needed to inform future clinical decision making.

Surgery for constipation: systematic review and practice recommendations: Results III: Rectal wall excisional procedures (Rectal Excision).

AIM: To assess the outcomes of rectal excisional procedures in adults with chronic constipation. METHOD: Standardised methods and reporting of benefits and harms were used for all CapaCiTY reviews that closely adhered to PRISMA 2016 guidance. Main conclusions were presented as summary evidence statements with a summative Oxford Centre for Evidence-Based Medicine (2009) level. RESULTS: Forty-seven studies were identified, providing data on outcomes in 8340 patients. Average length of procedures was 44 min and length of stay (LOS) was 3 days. There was inadequate evidence to determine variations in procedural duration or LOS by type of procedure. Overall morbidity rate was 16.9% (0-61%), with lower rates observed after Contour Transtar procedure (8.9%). No mortality was reported after any procedures in a total of 5896 patients. Although inconsistently reported, good or satisfactory outcome occurred in 73-80% of patients; a reduction of 53-91% in Longo scoring system for obstructive defecation syndrome (ODS) occurred in about 68-76% of patients. The most common long-term adverse outcome is faecal urgency, typically occurring in up to 10% of patients. Recurrent prolapse occurred in 4.3% of patients. Patients with at least 3 ODS symptoms together with a rectocoele with or without an intussusception, who have failed conservative management, may benefit from a rectal excisional procedure. CONCLUSION: Rectal excisional procedures are safe with little major morbidity. It is not possible to advise which excisional technique is superior from the point of view of efficacy, peri-operative variables, or harms. Future study is required.

Altered defaecatory behaviour and faecal incontinence in a video-tracked animal model of pudendal neuropathy.

AIM: The aim was to develop a behavioural animal model of faecal continence and assess the effect of retro-uterine balloon inflation (RBI) injury. RBI in the rat causes pudendal neuropathy, a risk factor for obstetric related faecal incontinence in humans. METHOD: Video-tracking of healthy rats (n = 12) in a cage containing a latrine box was used to monitor their defaecatory behaviour index (DBI) over 2 weeks. The DBI (range 0-1) was devised by dividing the defaecation rate (pellets per hour) outside the latrine by that of the whole cage. A score of 0 indicates all pellets were deposited in the latrine. Subsequently, the effects of RBI (n = 19), sham surgery (n = 4) and colostomy (n = 2) were determined by monitoring the DBI for 2 weeks preoperatively and 3 weeks postoperatively. RESULTS: The DBI for healthy rats was 0.1 ± 0.03 with no significant change over 2 weeks (P = 0.71). In the RBI group, 13 of 19 rats (68%) showed no significant change in DBI postoperatively (0.08 ±  -0.05 vs 0.11 ±  -0.07) while in six rats the DBI increased from 0.16 ±  -0.09 to 0.46 ± 0.23. The negative control, sham surgery, did not significantly affect the DBI (0.09 ± 0.06 vs 0.08 ± 0.04, P = 0.14). The positive control, colostomy, increased the DBI from 0.26 ± 0.03 to 0.86 ± 0.08. CONCLUSIONS: This is the first study showing a quantifiable change in defaecatory behaviour following injury in an animal model. This model of pudendal neuropathy affects continence in 32% of rats and provides a basis for research on interventions for incontinence.

Surgery for constipation: systematic review and practice recommendations: Graded practice and future research recommendations.

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.

Surgery for constipation: systematic review and clinical guidance: Paper 1: Introduction & Methods.

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.

Long-term outcomes of sacral nerve stimulation for faecal incontinence.

BACKGROUND: Sacral nerve stimulation (SNS) has proven short- to medium-term effectiveness for the treatment of faecal incontinence (FI); fewer long-term outcomes have been presented and usually in small series. Here, the long-term effectiveness of SNS was evaluated in a large European cohort of patients with a minimum of 5 years' follow-up. METHODS: Prospectively registered data from patients with FI who had received SNS for at least 5 years from ten European centres were collated by survey. Daily stool diaries, and Cleveland Clinic and St Mark's incontinence scores were evaluated at baseline, after implantation and at the last follow-up. SNS was considered successful when at least 50 per cent symptom improvement was maintained at last follow-up. RESULTS: A total of 407 patients underwent temporary stimulation, of whom 272 (66·8 per cent) had an impulse generator implanted; 228 (56·0 per cent) were available for long-term follow-up at a median of 84 (i.q.r. 70-113) months. Significant reductions in the number of FI episodes per week (from median 7 to 0·25) and summative symptom scores (median Cleveland Clinic score from 16 to 7, St Mark's score from 19 to 6) were recorded after implantation (all P < 0·001) and maintained in long-term follow-up. In per-protocol analysis, long-term success was maintained in 71·3 per cent of patients and full continence was achieved in 50·0 per cent; respective values based on intention-to-treat analysis were 47·7 and 33·4 per cent. Predictive analyses determined no significant association between pretreatment variables and successful outcomes. Risk of long-term failure correlated with minor symptom score improvement during the temporary test phase. CONCLUSION: SNS remains an effective treatment for FI in the long term for approximately half of the patients starting therapy.

Randomized clinical trial of sacral versus percutaneous tibial nerve stimulation in patients with faecal incontinence.

BACKGROUND: Sacral nerve stimulation (SNS) is a well established therapy for faecal incontinence (FI). Percutaneous tibial nerve stimulation (PTNS) is a newer, less invasive, treatment. The effectiveness and acceptability of these treatments have not been compared systematically. METHODS: An investigator-blinded randomized pilot trial of PTNS versus SNS with a parallel qualitative study was performed. Quantitative clinical outcomes and qualitative data from patient interviews were collected for both interventions. RESULTS: Forty patients (39 women; mean age 59 years) met the eligibility criteria; 23 were randomized to receive SNS and 17 to PTNS. Fifteen patients progressed to permanent SNS implantation and 16 received a full course of PTNS. Within-group effect sizes were marginally greater for SNS than for PTNS on available-case analysis. Mean(s.d.) FI episodes per week at baseline, and 3 and 6 months of follow-up were: 11·4(12·0), 4·0(4·0) and 4·9(6·9) respectively for SNS compared with 10·6(11·2), 5·8(6·9) and 6·3(6·9) for PTNS. Mean(s.d.) Cleveland Clinic Incontinence Score values at baseline, and 3 and 6 months were: 16·2(3·0), 11·1(5·2) and 10·4(5·6) for SNS versus 15·1(2·7), 11·7(4·4) and 12·1(5·2) for PTNS. Improvement of at least 50 per cent in FI episodes per week at 6 months was seen in 11 of 18 patients in the SNS group compared with seven of 15 in the PTNS group. Effect estimates for SNS with chronic implanted stimulation were larger (10 of 15 patients at 6 months). Disease-specific and generic quality-of-life improvements complemented clinical outcome data. Qualitative analysis of interview data suggested that both treatments had high acceptability amongst patients. CONCLUSION: In the short term, both SNS and PTNS provide some clinical benefit to patients with FI. Registration numbers: 2010-018728-15 and 10479 (http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=10479).

A double-blinded randomized multicentre study to investigate the effect of changes in stimulation parameters on sacral nerve stimulation for constipation.

AIM: Sacral nerve stimulation (SNS) may be offered to patients with constipation who have failed to improve with conservative treatment. The response to SNS is variable, with a significant loss of efficacy in some patients. An increased frequency of stimulation may improve the efficacy of SNS for faecal incontinence. This study aimed to see if alteration of the pulse width or frequency improved the outcome for those with constipation. METHOD: Eleven patients with constipation currently being treated by SNS were recruited from three centres. They were randomized to five different protocols of stimulation each applied for 5 weeks. Group 1 used standard settings (pulse width 210 µs, frequency 14 Hz); in the other four groups (Groups 2-5) the pulse width and/or frequency were halved or doubled. Patients and investigators were blinded to the group allocation. RESULTS: The Cleveland Clinic constipation score varied significantly between the five groups. Group 1 achieved the lowest score mean (± SD) 13.4 (± 4.4) (P = 0.03). The number of digitations per defaecation was the lowest in Group 4, 90 µs and 14 Hz (P < 0.01). No other variable changed significantly. Standard settings were the most preferred by the recruited patients. CONCLUSION: Alteration of pulse width or frequency of stimulation had no significant effect on the outcome of SNS for constipation.

Systematic review of tibial nerve stimulation to treat faecal incontinence.

BACKGROUND: Two forms of tibial nerve stimulation are used to treat faecal incontinence (FI): percutaneous (PTNS) and transcutaneous (TTNS) tibial nerve stimulation. This article critically appraises the literature on both procedures. METHODS: A systematic review was performed adhering to the PRISMA framework. A comprehensive literature search was conducted, with systematic methodological quality assessment and data extraction. Summary measures for individual outcome variables are reported. RESULTS: Twelve articles met eligibility criteria; six related to PTNS, five to TTNS, and one to both procedures. These included ten case series and two randomized clinical trials (RCTs). Case series were evaluated using the National Institute for Health and Care Excellence quality assessment for case series, scoring 3-6 of 8. RCTs were evaluated using the Jadad score, scoring 4 of a possible 5 marks, and the Cochrane Collaboration bias assessment tool. From one RCT and case series reports, the success rate of PTNS, based on the proportion of patients who achieved a reduction in weekly FI episodes of at least 50 per cent, was 63-82 per cent, and that of TTNS was 0-45 per cent. In an RCT of TTNS versus sham, no patient had a reduction in weekly FI episodes of 50 per cent or more, whereas in an RCT of PTNS versus TTNS versus sham, 82 per cent of patients undergoing PTNS, 45 per cent of those having TTNS, and 13 per cent of patients in the sham group had treatment success. CONCLUSION: PTNS and TTNS result in significant improvements in some outcome measures; however, TTNS was not superior to sham stimulation in a large, adequately powered, RCT. As no adequate RCT of PTNS versus sham has been conducted, conclusions cannot be drawn regarding this treatment.