Time trend in the surgical management of obstructed defecation syndrome: a multicenter experience on behalf of the Italian Society of Colorectal Surgery (SICCR).

BACKGROUND: Surgical management of obstructed defecation syndrome (ODS) is challenging, with several surgical options showing inconsistent functional results over time. The aim of this study was to evaluate the trend in surgical management of ODS in a 10-year timeframe across Italian referral centers. METHODS: Surgeons from referral centers for the management of pelvic floor disorders and affiliated to the Italian Society of Colorectal Surgery provided data on the yearly volume of procedures for ODS from 2010 to 2019. Six common clinical scenarios of ODS were captured, including details on patient's anal sphincter function and presence of rectocele and/or rectal intussusception. Perineal repair, ventral rectopexy (VRP), transanal repair (internal Delorme), stapled transanal rectal resection (STARR), Contour Transtar, and transvaginal repair were considered in each clinical scenario. RESULTS: Twenty-five centers were included providing data on 2943 surgical patients. Procedure volumes ranged from 10-20 (54%) to 21-50 (46%) per year across centers. The most performed techniques in patients with good sphincter function were transanal repair for isolated rectocele (243/716 [34%]), transanal repair for isolated rectal intussusception (287/677 [42%]) and VRP for combined abnormalities (464/976 [48%]). When considering poor sphincter function, these were perineal repair (112/194 [57.8%]) for isolated rectocele, and VRP for the other two scenarios (60/120 [50%] and 97/260 [37%], respectively). The use of STARR and Contour Transtar decreased over time in patients with impaired sphincter function. CONCLUSIONS: The complexity of ODS treatment is confirmed by the variety of clinical scenarios that can occur and by the changing trend of surgical management over the last 10 years.

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).

Preventing transmission among operating room staff during COVID-19 pandemic: the role of the Aerosol Box and other personal protective equipment.

The COVID-19 pandemic is highly challenging for the operating room staff and healthcare workers in emergency departments. SARS-CoV-2 is a positive-sense single-stranded RNA beta-coronavirus that primarily targets the human respiratory system, with fever, cough, myalgia, and pneumonia as the most common manifestations. However, since SARS-CoV-2 RNA was detected in stool specimens much more attention has been paid to gastrointestinal symptoms such as loss of appetite, nausea, and diarrhea. Furthermore, the expression of ACE-2 receptors in absorptive enterocytes from ileum and colon suggests that these organs should also be considered as a potential high risk for SARS-CoV-2 infection. During aerosol-generating medical procedures (AGMP; e.g. intubating and extubating patients or any surgical procedures), the production of both airborne particles and droplets may increase the risk of infection. In this situation, the surgical staff is strongly recommended to wear personal protective equipment (PPE). A transparent plastic cube, the so-called "Aerosol Box" (AB), has been recently designed to lend further protection against droplets and aerosol exposure during the AGMP.

Fistulotomy and primary sphincteroplasty for anal fistula: long-term data on continence and patient satisfaction.

BACKGROUND: The aim of this study was to evaluate the safety and long-term efficacy of fistulotomy and primary sphincteroplasty (FIPS). Secondary endpoints were its impact on postoperative continence status and patients' satisfaction. METHODS: A retrospective study was conducted on patients with cryptoglandular anal fistula (AF) who had FIPS between June 2006 and May 2017. Patients were evaluated with standardized telephone interviews and clinical/instrumental assessment. Main outcome measures included fistula healing rate, continence status, and patient satisfaction. Incontinence was defined as an inability to hold either gas, liquid, or solid stools, as well as postdefecation soiling, and was measured by the Cleveland Clinic fecal incontinence score. Patient satisfaction was evaluated by an 11-point numeric rating scale. RESULTS: There were 203 patients (139 males; mean age: 48.7 years) who had FIPS. The overall healing rate was 93% (188 patients) with a mean follow-up period of 56 ± 31 months. Half of the total cohort (51%) had a complex fistula. Preoperatively, 8 (4%) patients complained of postdefecation soiling and 2 (1%) of gas incontinence. Postoperatively, 26 (13%) patients had continence impairment (de novo n = 24), mainly consisting of postdefecation soiling (10%). In univariate analysis, patients with recurrent (RR 6.153 95% CI 2.097-18.048; p = 0.002) or complex (RR 3.005 95% CI 1.203-7.506; p = 0.012) AF and those with secondary tracts (RR 8.190 95% CI 2.188-30.654; p = 0.004) or previous set on drainage (RR 5.286 95% CI 2.235-12.503; p = 0.0001) were at higher risk of incontinence. In multivariate analysis, no significant predictors were found, although fistula complexity approached statistical significance (RR 5.464 95% CI 0.944-31.623; p = 0.050). The mean patient satisfaction numeric rating scale was 9.3 ± 1.6. Lower satisfaction rates were found in patients with transphincteric (p = 0.011) or complex (p = 0.0001) AF, with secondary tracts (p = 0.041) or previous seton drainage (p = 0.008), and in those with postoperative continence impairment (p = 0.0001). Postoperative onset of incontinence was the only significant factor in multivariate analysis (p = 0.0001). CONCLUSIONS: FIPS should be considered a valid therapeutic option for selected AF. However, the risk of postoperative minor fecal incontinence exists, and should be discussed during preoperative patient counselling.

Contemporary surgical practice in the management of anal fistula: results from an international survey.

BACKGROUND: Management of anal fistula (AF) remains challenging with many controversies. The purpose of this study was to explore current surgical practice in the management of AF with a focus on technical variations among surgeons. METHODS: An online survey was conducted by inviting all surgeons and physicians on the membership directory of European Society of Coloproctology and American Society of Colon and Rectal Surgeons. An invitation was extended to others via social media. The survey had 74 questions exploring diagnostic and surgical techniques. RESULTS: In March 2018, 3572 physicians on membership directory were invited to take part in the study 510 of whom (14%) responded to the survey. Of these respondents, 492 (96%) were surgeons. Respondents were mostly colorectal surgeons (84%) at consultant level (84%), age ≥ 40 years (64%), practicing in academic (53%) or teaching (30%) hospitals, from the USA (36%) and Europe (34%). About 80% considered fistulotomy as the gold standard treatment for simple fistulas. Endorectal advancement flap was performed using partial- (42%) or full-thickness (44%) flaps. Up to 38% of surgeons performed ligation of the intersphincteric fistula tract (LIFT) sometimes with technical variations. Geographic and demographic differences were found in both the diagnostic and therapeutic approaches to AF. Declared rates of recurrence and fecal incontinence with these techniques were variable and did not correlate with surgeons' experience. Only 1-4% of surgeons were confident in performing the most novel sphincter-preserving techniques in patients with Crohn's disease. CONCLUSIONS: Profound technical variations exist in surgical management of AF, making it difficult to reproduce and compare treatment outcomes among different centers.

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.

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 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 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.

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.

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.

Pathophysiology of fecal incontinence differs between men and women: a case-matched study in 200 patients.

BACKGROUND: Fecal incontinence (FI) is a common and socially disabling condition with obstetric trauma considered the principal etiological factor. This study aimed to systematically evaluate symptom presentation and anorectal function in both females and males with FI. METHODS: One hundred males (M) and 100 age-matched females (F) with FI presenting between 2012 and 2014 were identified from a prospectively collected database. Comparison of clinical (history, symptom profile, and severity using validated questionnaires) and anorectal physiological (manometry, rectal sensory testing, endoanal ultrasonography, and evacuation proctography) data between M and F was performed. KEY RESULTS: Incidence of prior anal surgery (M: 28% vs F: 18%, p = 0.13) and abdominal surgery (M: 25% vs F: 26%, p = 0.90) was similar between sexes, but females had a higher incidence of previous pelvic surgery (M: 4% vs F: 47%, p < 0.001). Eighty-five females were parous and 75% reported history of traumatic vaginal delivery. There was a trend toward higher St Mark's incontinence scores in females (mean ± SD; M: 13 ± 4 vs F: 14 ± 5, p = 0.06). In men, structural sphincter abnormalities were uncommon (M: 37% vs F: 77%, p < 0.001), while impaired rectal sensation (M: 24% vs F: 7%, p = 0.001) and functional disturbances of evacuation (M: 36% vs F: 13%, p = 0.001) were more common than in women. No abnormality on all tests performed was observed in twice as many males (M: 18% vs F: 9%, p = 0.10). CONCLUSIONS & INFERENCES: Pathophysiological mechanisms of FI differ between sexes. Anal sphincter dysfunction was an uncommon finding in males, with impaired rectal sensation and functional disturbances of evacuation much more prominent than in the female cohort. These findings are likely to impact options for symptom management.

Incidence of upper aerodigestive tract cancer after liver transplantation for alcoholic cirrhosis: a 10-year experience in an Italian center.

INTRODUCTION: The aim of this study was to evaluate the incidence, clinical characteristics, treatment, and outcome of de novo tumors (DNT) of the upper aerodigestive tract in patients with alcoholic cirrhosis after orthotopic liver transplantation (OLT). METHODS: Among 225 consecutive OLT performed between January 2002 and January 2012, a total of 205 patients received a first liver allograft. Eleven (4.9%) patients developed DNT (lung, pancreas, bowel, esophagus, larynx, tongue, tonsil, and lymphoma). Among these, we observed 5 patients with DNT of the upper aerodigestive tract. RESULTS: The 5 patients with DNT of the upper aerodigestive tract underwent OLT for alcoholic cirrhosis. There were 4 men and 1 woman with a mean age at transplantation of 47 years. The mean period of alcohol abuse was 90 months. The tumors occurred after a mean post-transplantation time of 39 months. The immunosuppressive regimen included Tacrolimus, mTOR, mycophenolate mofetil (MMF), and low-dose steroids. We observed 2 cases of squamous cell carcinoma of the esophagus, 1 case of tonsillar cancer, 1 case of larynx carcinoma, and 1 case of tongue carcinoma. All patients underwent surgical excision. After surgery, 4 patients received chemotherapy and 2 patients radiotherapy. At present, among the 5 patients with DNT of the upper aerodigestive tract, only 2 are alive without disease and 1 is alive with a local recurrence. CONCLUSION: The incidence of DNT of the upper aerodigestive tract after OLT is higher among patients receiving a transplant for alcoholic cirrhosis. This could be due to an additional effect of post-transplantation immunosuppression in patients exposed to alcohol before transplantation. We suggest a careful post-transplantation follow-up and more attention to improve early diagnosis.