Abstract Fistula in ano is a common anorectal disease in adults. Currently, surgery remains the definitive therapeutic approach, but in some cases, it can lead to serious complications as faecal or gas incontinence. Therefore, sphincter sparing treatments should be considered for complex fistulas. One of the sphincteric preserving treatment is the filling with a dermal extract commonly called “collagen glue” as Salvecoll-E® gel. This is a multicentric, prospective, observational study on the use of Salvecoll-E® gel in treatment of complex anal fistulas. We treated 70 patients from May 2016 to May 2017. In the first phase, we debrided the fistula tract using a loose seton kept for 4–6 weeks. In the second phase, the seton was removed and the fistula tract was filled with Salvecoll-E® gel. In this article, we report results at 36 months of follow-up. Fifty patients (71.4%) had completely healed fistula within 36 months of follow-up. Twenty-eight patients (28.2%) had recurrences. Among these failures, 65% were within 6 months. All low transphincteric fistulas healed. Recurrences occurred only in median and high transphincteric fistulas. No patient had a worsening of continence status measured with Cleveland Clinic Florida Incontinence Severity score. Salvecoll-E® gel is a recent finding among sphincter-sparing treatments. In this study, we demonstrate that it is a safe option in the treatment of complex fistulas. Final results are satisfactory and in line with the best results published in literature among mini-invasive treatments.

BACKGROUND:Fistula-in-ano is one of the most commonly presenting anorectal diseases. Sphincter sparing treatment options should be considered in patients with complex fistulas. Salvecoll-E gel is a native collagen deantigenated and purified, non-cross-linked equine dermal extract, with an amino acid composition identical to human collagen. METHODS:The multicentric trial study was a prospective, single-arm observational clinical study with the objective to assess the efficacy of Salvecoll-E gel for anal fistula repair in 70 patients. All patients had undergone preliminary surgical treatment consisting of positioning of a draining loosing seton that was maintained for a period of 4-6 weeks. After seton removal, a gentle debridement and washing of the fistula track was performed. The scar tissue was removed from the internal orifice. Internal opening was covered by a side-to side mucosal suture. Salvecoll-E was injected through the external opening into the fistula track, the external opening it has been opened. RESULTS:Twelve months after surgery, 55 patients demonstrated a clinically healed fistula (78,5%), 15 patients have a recurrence (21,5%). Most of the recurrences were observed in the first 6 months of treatment (13/15, 86.6%). We don't observe any worsening in CCF score. The results obtained at 1 year certainly seem satisfactory and in line with the best results published in literature using mini-invasive techniques. CONCLUSION:Salvecoll-E gel is a promising non-invasive technique for conservative treatment of anal fistulas, it's well tolerated by the patients and, in case of recurrence, reinjection or all other known techniques are feasible.

This DIB article provides additional data on laparoscopic lateral suspension with mesh for correcting pelvic organ prolapse. Data come from a multicentric sample of Italian women (https://doi.org/10.1016/j.ejogrb.2019.07.025). Data are collected retrospectively. Descriptive and raw data on surgery and descriptive and raw data on symptoms of pelvic organ prolapse pre-surgery and post-surgery are provided. Kaplan-Meier curves and scores of 7-items King's Health Questionnaire for quality of life assessment are also reported.

Aim: PermacolTM collagen paste (PermacolTM paste) is an acellular cross-linked porcine dermal collagen matrix suspension for use in soft tissue repair. The use of PermacolTM paste in the filling of anorectal fistula tract is a new sphincter-preserving method for fistula repair. The MASERATI100 study was a prospective, observational clinical study with the objective to assess the efficacy of PermacolTM collagen paste for anal fistula repair in 100 patients. A cc ep te d A rt ic le This article is protected by copyright. All rights reserved. Method: Patients (N=100) with anal fistula were treated at ten European surgical sites with a sphincter-preserving technique using PermacolTM paste. Fistula healing was assessed at 1, 3, 6, and 12 months post-treatment, with the primary endpoint being healing at 6 months. Faecal continence and patient satisfaction were surveyed at each follow-up; adverse events (AEs) were monitored throughout the follow-up. Results: At 6 months post-surgery, 56.7% of patients were healed, and the percentage healed was largely maintained, with 53.5% healed at 12 months. 29.0% of patients had at least one AE, and 16.0% of patients had one or more procedure-related AE. Most AEs reported were minor and similar to those commonly observed after fistula treatment, and the incidence of serious adverse events was low (4.0% of patients). Regardless of treatment outcome, 73.0% of patients were satisfied or very satisfied with the procedure. Conclusion: PermacolTM paste provides a promising sphincter-preserving treatment for anal fistulas with minimal adverse side-effects. ClinicalTrials.gov Identifier: NCT01624350

AimPermacol collagen paste (Permacol paste) is an acellular cross-linked porcine dermal collagen matrix suspension for use in soft-tissue repair. The use of Permacol paste in the filling of anorectal fistula tract is a new sphincter-preserving method for fistula repair. The MASERATI100 study was a prospective, observational clinical study with the objective to assess the efficacy of Permacol collagen paste for anal fistula repair in 100 patients. MethodPatients (n=100) with anal fistula were treated, at 10 European surgical sites, with a sphincter-preserving technique using Permacol paste. Fistula healing was assessed at 1, 3, 6 and 12months post-treatment, with the primary end-point being healing at 6months. Faecal continence and patient satisfaction were surveyed at each follow-up; adverse events (AEs) were monitored throughout the follow-up. ResultsAt 6months postsurgery, 56.7% of patients were healed and the percentage healed was largely maintained, with 53.5% healed at 12months. Regarding AEs, 29.0% of patients had at least one AE, and 16.0% of patients had one or more procedure-related AE. Most AEs reported were minor and similar to those commonly observed after fistula treatment, and the incidence of serious adverse events was low (4.0% of patients). Regardless of treatment outcome, 73.0% of patients were satisfied or very satisfied with the procedure. ConclusionPermacol paste is a promising sphincter-preserving treatment for anal fistulae and has minimal adverse side-effects.

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.

Introduction Historically, the treatment of anal fistulas has required a compromise between successful fistula healing and preservation of continence. The aim of this study (NCT01624350) is to evaluate clinical outcomes of anal fistulas treated with Permacol™ collagen paste. Method Patients (N = 98) with magnetic resonance imaging-confirmed intersphincteric or transsphincteric anal fistulas, cryptoglandular primary or recurrent, from ten European sites were treated with Permacol™ collagen paste. Fistula healing, adverse events, and patient satisfaction were assessed up to 12 months post-surgery, with fistula healing at 6 months confirmed by clinical assessment as the primary endpoint. Cox regression analyses were performed to determine if patient or fistula characteristics correlate with better healing. Results The median follow-up was 26.8 weeks (range 0.1–62.4 weeks), with 87 and 46 patients having healing data at 6 months and 12 months, respectively. At 6 months follow-up, 51 (58.6%) patients exhibited a clinically-healed anal fistula, including 20/35 (57.1%) that were recurrent at the time of treatment. At 12 months, 19 (41.3%) patients were healed. Younger patients and those with evidence of expulsion or leakage of Permacol™ collagen paste were the only variables associated with a significantly increased risk of failure (p = 0.0017 and p = 0.0068, respectively). A total of six serious adverse events were reported, four of which (perianal abscess, n = 2; non-healing fistula tract, n = 1; complex regional pain syndrome, n = 1) were possibly related to the device and/or the procedure. Continence was preserved throughout the follow-up. At their last visit, over 70% of patients reported being satisfied or very satisfied with their operation, indicating that some patients were satisfied even though their fistula did not heal. Conclusion These preliminary results demonstrate that Permacol™ collagen paste is a well-tolerated, sphincter-sparing technique for the treatment of anal fistulas with low morbidity. Disclosure of interest P. Giordano Grant/Research Support from: Covidien, Consultant for: Covidien, Speaker Bureau of: Covidien, P. Sileri Grant/Research Support from: Covidien, S. Buntzen Grant/Research Support from: Covidien, Speaker Bureau of: Medtronic, A. Stuto Grant/Research Support from: Covidien, J. Nunoo-Mensah Grant/Research Support from: Covidien, L. Lenisa Grant/Research Support from: Covidien, B. Singh Grant/Research Support from: Covidien, Speaker Bureau of: Covidien, O. Thorlacius-Ussing Grant/Research Support from: Covidien, B. Griffiths Grant/Research Support from: Covidien, D. Ziyaie Grant/Research Support from: Covidien, Speaker Bureau of: Covidien.

OBJECTIVES:Stapled transanal rectal resection (STARR) is a promising new treatment for obstructed defecation syndrome (ODS) associated with rectal intussusception and/or rectocele. The aim of this work was to assess the efficacy of STARR to treat ODS.METHODS:Outcome data after STARR for ODS were pooled according to the used constipation score. As different types of constipation scores were reported, and standardized effect sizes were calculated before performing a meta-analysis.RESULTS:Twenty-six publications were identified with a median follow-up of 12 months (range: 3-42). In total 1298 patients were included. Six different scoring systems were used. In total 43 estimates of the effect STARR were analyzed. All studies showed a significant improvement in ODS yielding a combined standardized effect size of 3.8 (95% CI : 3.2-4.5). Although a very high degree of heterogeneity between effect sizes has been observed (I2 = 93.3%), suggesting an overestimation of this improvement. This is partially due to the use of various instruments, but largely originating from (unmeasured) study characteristics.CONCLUSIONS:The consistent finding of a decrease in the various ODS-scores confirms that STARR can reduce ODS but the effect is overestimated. This meta-analysis clearly highlights some methodological shortcomings in published data. Heterogeneity in ODS scoring implies the need for standard effect size calculation to compare published results, and underlines the urgent need for a more uniform and accurate data reporting.

INTRODUCTION:Longo's technique (or PPH technique) is well known worldwide. Meta-analysis suggests that the failure due to persistence or recurrence is close to 7.7%. One of the reasons for the recurrence is the treatment of the advanced hemorrhoidal prolapse with a single stapling device, which is not enough to resect the appropriate amount of prolapse.MATERIALS AND METHODS:We describe the application of "Double PPH Technique" (D-PPH) to treat large hemorrhoidal prolapses. We performed a multicentric, prospective, and nonrandomized trial from July 2008 to July 2009, wherein 2 groups of patients with prolapse and hemorrhoids were treated with a single PPH or a D-PPH. Results were compared. The primary outcome was evaluation of safety and efficacy of the D-PPH procedure in selected patients with large hemorrhoidal prolapse.RESULTS:In all, 281 consecutive patients suffering from hemorrhoidal prolapse underwent surgery, of whom 74 were assigned intraoperatively to D-PPH, whereas 207 underwent single PPH. Postoperative complications were 5% in both groups (P = .32), in particular: postoperative major bleeding 3.0% in PPH versus 4.1% D-PPH (P = .59); pain 37.9 % PPH versus 27.3% D-PPH (mean visual analog scale [VAS] = 2.5 vs 2.9, respectively; P = .72); and fecal urgency 2.1% PPH versus 5.7% D-PPH (P = .8). Persistence of hemorrhoidal prolapse at 12-month follow-up was 3.7% in the PPH group versus 5.9% in the D-PPH group (P = .5).CONCLUSIONS:Our data support the hypothesis that an accurate intraoperative patient selection for single (PPH) or double (D-PPH) stapled technique will lower in a significant way the incidence of recurrence after Longo's procedure for hemorrhoidal prolapse.

body mass index (BMI), previous abdominal surgeries, and comorbidities including chronic obstructive pulmonary disease (COPD), coronary artery disease (CAD), hypertension, diabetes mellitus (DM), chronic kidney disease (CKD), and nicotine dependence.Our goal was to determine significant differences between the two groups with regard to postoperative pain, wound infection, hernia formation, postoperative ileus, septic complications, length of hospital stay, readmission rate, time interval for postoperative chemotherapy if indicated, symptom distress score (SDS), Visick grade, Quality of life Index (QLI) and cosmetic score.Results: The two groups were comparable for all categories.Follow up was available on all patients (100%).At a mean follow-up of 25.23 months (range 6-53, there was no difference between postoperative pain between the two groups on postoperative day one, postoperative day two or greater than 2 weeks (p= .571),(p=.861),(p=.688),respectively.The NOSE group had no postoperative hernia formation or wound infections compared to the LARH group which had 10% hernia formation rate and 5% wound infection rate, however the difference was not significant (p= .439)and(p=.267),respectively.There was no difference between groups in postoperative ileus (p=.192), septic complications (p=1.000),length of hospital stay (p=.243), readmission rate (p=.394), time interval for postoperative chemotherapy (p=.645),SDS (p=.446),Visick grade (p=.176) or QLI (p=.175).The NOSE group, however, have statically significant better cosmetic scores (p.018).Conclusion: NOSE is comparable LARH with regard to short and long term postoperative outcomes.NOSE is associated with better cosmetic outcome.

AIM:Selected patients with haemorrhoidal prolapse undergoing double stapled anopexy with the procedure for prolapse and haemorrhoids (PPH03) were studied.METHOD:Between March 2007 and March 2010, 235 patients referred with haemorrhoids were included in the study. Patients with obstructed defaecation were excluded. At surgery intraoperative evaluation for double stapled anopexy was carried out based on the criteria of prolapse occupying half or more of the anal circumference and redundant prolapsed tissue determined by the circular anal dilator. Patients fulfilling these criteria were submitted for double stapled anopexy with the PPH03 stapler. All clinical and operative data were recorded in a prospectively maintained database.RESULTS:Among the 142 patients with haemorrhoidal prolapse having surgery 91 had a single and 51 a double stapled technique. The mean operative time was 34.8 min with no major or minor intraoperative complications. Recurrence at 48 months was 1.9% and the mean satisfaction score was 8.9.CONCLUSION:The double stapled PPH03 technique in selected cases was as safe and effective as a single stapling technique with a lower incidence of recurrence over a medium-term follow-up.

Purpose: This study was designed to evaluate the safety and efficacy of Stapled Trans-Anal Rectal Resection (STARR) in the treatment of Obstructed Defecation Syndrome ODS by the analysis of the data collected in the STARR Italian Registry (SIR) with a special emphasis on the analysis of symptoms and quality of life. Methods: Collected data included, preoperative tests findings, and the evaluation of symptoms; the latter was obtained by using dedicated tools such as the Obstructed Defecation Syndrome Score (ODS-S), the Severity Symptom Score (SSS), and the Continence Grading Scale (CGS). Data on the quality of life were collected by Patient Assessment of Constipation Quality of Life (PAC-QoL) and the Euro Quality of Life-5 Domains Visual Analogue Scale (EQ-5D VAS). The evaluation of the symptoms and the quality of life was repeated 6 and 12 months after surgery. Results: The SIR had collected data on 2171 patients (1653 females, 76.1%; mean age 56.2years; range 20-96 years). A significant improvement (P < .0001) was seen between preoperative and 12-month follow-up in all scores: ODS-S (16.7 vs 5.0), SSS (15.6 vs 2.6), CGS (2.0 vs 0.7), PAC-QoL (51.0 vs 22.1), and EQ-5D VAS (57.5 vs 85.7). Complications included defecatory urgency (4.5% at 12 months), bleeding (3.6%), perineal sepsis (3.4%), and one case of rectovaginal fistula (0.05%). Conclusion: The analysis of SIR data seems to confirm that STARR is a safe and effective procedure in the treatment of ODS. However, further studies are required to evaluate the long-term stability of results.

The original stapled transanal rectal resection (STARR) technique utilized two firings of a PPH01 stapler to achieve separate anterior and posterior resections of the distal rectum. More recently, a device specifically designed for STARR has been introduced: the Contour Transtar. This enables a greater extent of prolapse to be resected as a single specimen. Both techniques are described in detail together with “tips and tricks” for a successful outcome.

ObjectiveThe stapled transanal rectal resection (STARR) in patients with defecation disorders is limited by the shape and capacity of the circular stapler. A new device has been recently developed, the Contour((R)) Transtar((TM)) stapler, in order to improve the safety and effectiveness of the STARR technique. The study has been designed to confirm this declaration.MethodFrom January to June 2007 a prospective European multicentre study of consecutive patients with defecation disorder caused by internal rectal prolapse underwent the new STARR technique. The assessment of perioperative morbidity and functional outcome after 6 weeks, 3 and 12 months was documented by different scores.ResultsIn all 75 patients, median age 64, the Transtar procedure was performed with 9% intraoperative difficulties, 7% postoperative complications and no mortality. The mean reduction of the ODS score was -15.6 (95%-CI: -17.3 to -13.8, P < 0.0001), mean reduction of SSS was -12.6 (95%-CI: -14.2 to -11.2; P < 0.0001). 41% stated improvement of their continence status by CCF score, only 4 patients (5%) had deterioration.ConclusionThe Transtar procedure is technically demanding, with good functional results similar to the conventional STARR.