Search

Summary: 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. Keywords: Complex ano-rectal fistula, Non cutting technique, Mini-invasive treatment

Objective Illustrating the outcomes of laparoscopic lateral suspension by mesh for pelvic organ prolapse repair. Study design A retrospective observational study was conducted collecting medical records of 48 patients treated between May 2016 and April 2018 in two different centers in Italy. Pre- and post-operative clinical evaluations as well as patients’ satisfaction scores were considered. Patients were followed for two years. Statistical analysis was determined using the chi-square test in intention-to-treat and per-protocol analyses, while Kaplan-Meier curves were built for assessing the prolapse recurrence and the symptoms recurrence. The Steel-Dwass test for pairwise comparisons was used to compare median scores from the King's General Health Perception Questionnaire answers. Results Regarding the anatomical result, the outcome was either optimal or satisfactory (PoP-Q ≤1) at 12 months in 92% of patients for anterior compartment, in 100% for apical compartment, and in 75% for posterior compartment (intention-to-treat). Kaplan-Meier curves depicted a repair of prolapse in 70% of cases, with better outcomes for the anterior and the apical compartment. Patient self-perception of health was over 80% at each follow-up evaluation. Conclusion Laparoscopic lateral suspension is a reasonable technique for treatment of pelvic organ prolapse. Further studies are needed to prove such a technique versus alternative surgeries.

AIM: Permacol™ 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.METHOD: Patients (N=100) with anal fistula were treated at ten European surgical sites with a sphincter-preserving technique using Permacol™ 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: Permacol™ paste provides a promising sphincter-preserving treatment for anal fistulas with minimal adverse side-effects. This article is protected by copyright. All rights reserved.

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 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 ten 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 endpoint 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 six 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 fistulas and primary or recurrent fistulas. 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 was shown to be effective in treating primary and recurrent cryptoglandular anorectal fistula with minimal unwanted side effects. This article is protected by copyright. All rights reserved.

PURPOSE: Stapled transanal rectal resection is advocated for the treatment of obstructed defecation syndrome. Supporting evidence for its safety and effectiveness has been lacking. To address this, the European Stapled Transanal Rectal Resection Registry was initiated in January 2006. This study was designed to analyze 12-month postoperative outcomes of this procedure using data collected in the registry. METHODS: On May 17, 2008, data were downloaded from the Stapled Transanal Resection Registry to perform an analysis of 12-month outcomes. Data had been collected prospectively on effectiveness (symptom severity and obstructed defecation scores), quality of life, incontinence, and safety profile at baseline, 6 weeks, 6 months, and 12 months. RESULTS: A total of 2,838 patients were entered into the registry, of whom 2,224 had reached 12 months of follow-up. Mean age was 54.7 years. A total of 2,363 patients (83.3%) were female. A significant improvement was seen in obstructive defecation and symptom severity scores and quality of life between baseline and 12 months (obstructed defecation score: 15.8 vs. 5.8, respectively, P < 0.001; symptom severity score: 15.1 vs. 3.6, respectively, P < 0.001). Complications were reported in 36.0% and included defecatory urgency (20.0%), bleeding (5.0%), septic events (4.4%), staple line complications (3.5%), and incontinence (1.8%). One case of rectal necrosis and one case of rectovaginal fistula were reported. CONCLUSION: Stapled transanal rectal resection produces improved function and better quality of life for patients with obstructed defecation that is maintained at 12 months of follow-up. Further investigation is required to optimize patient selection and reduce the potential complications of postoperative defecatory urgency and pain.

Objective The 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® Transtar™ stapler, in order to improve the safety and effectiveness of the STARR technique. The study has been designed to confirm this declaration. Method From 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. Results In 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

This study was designed to assess the safety and outcomes achieved with stapled transanal rectal resection vs. biofeedback training in obstructed defecation patients.A total of 119 women patients who suffered from obstructed defecation with associated rectocele and rectal intussusception were randomized to stapled transanal rectal resection or biofeedback training. Stapled transanal rectal resection was performed by using two circular staplers to produce transanal full-thickness rectal resection. Primary outcome was symptoms of obstructed defecation resolution at 12 months; secondary outcomes included safety, change in quality of life score, and anatomic correction of rectocele and rectal intussusception.Fourteen percent (8/59) stapled transanal rectal resection and 50 percent (30/60) biofeedback training patients withdrew early. Eight (15 percent) patients treated with stapled transanal rectal resection and 1 (2 percent) biofeedback patient experienced adverse events. One serious adverse event (bleeding) occurred after stapled transanal rectal resection. Scores of obstructed defecation improved significantly in both groups as did quality of life (both P0.0001). Successful treatment was observed in 44 (81.5 percent) stapled transanal rectal resection vs. 13 (33.3 percent) evaluable biofeedback training patients (P0.0001). Functional benefit was observed early and remained stable during the study.In this controlled trial, stapled transanal rectal resection was well tolerated, was more effective than biofeedback training for the resolution of obstructed defecation symptoms, and improved quality of life, with minimal risk of impaired continence. Thus, stapled transanal rectal resection offers a new treatment alternative for obstructed defecation after failure of conservative measures including biofeedback training, a noninvasive approach.

Internal rectal prolapse (rectal intussusception) and rectocele are frequent clinical findings in patients suffering from refractory constipation that may be best characterized as obstructive defecation syndrome. However, there is still no clear evidence whether the stapled transanal rectal resection (STARR) procedure provides a safe and effective surgical option for symptom resolution in patients with obstructive defecation syndrome, as evidence-based guidelines and functional long-term results are still missing. On the basis of the need for objective evaluation, a European group of experts was founded (Stapled Transanal Rectal Resection Pioneers). Derived from 2 meetings (October 26-28, 2006, Gouvieux, France and November 28-29, 2007, St Gallen, Switzerland) a concept for treatment options in patients suffering from obstructive defecation syndrome was developed, including a clear decision-making algorithm specifically focusing on the role of the stapled transanal rectal resection procedure based on clinical symptoms and dynamic imaging and inclusion and exclusion criteria for the stapled transanal rectal resection procedure.

The surgical procedure of stapled haemorrhoidopexy is now considered safe, and its reliability is improving with experience and technical upgrading. Compared to conventional procedures, the short-term advantages of stapled haemorrhoidopexy include less postoperative pain, faster recovery and healing, whereas the disadvantages of the procedure in the long term include an increased possibility of recurrent prolapse. The percentage of symptomatic prolapse after stapled procedures widely varies in the several clinical trials described in the literature, ranging between 2 and 53.3 % [1]. Many shortand long-term complications of the different treatments for haemorrhoids (conventional, stapled or realized with different new devices) have been reported in the literature [2]. Less evidence is available about how to minimize these undesirable effects of stapling procedures, and there are no studies that describe and classify recurrences and the strategies to deal with them. We performed a retrospective study on 69 patients with recurrent prolapse after stapled haemorrhoidopexy [58 patients treated with a single-stapled procedure and 11 with a double-stapled procedure for prolapse and haemorrhoids (DSPPH)] who underwent re-intervention for recurrence. Prolapse over half of the circular anal dilator (CAD) is usually treated with a double stapling technique [3]. Thirty-five patients were female, and 34 were male. The mean age was 50 years (range 25–74 years). The follow-up was performed in the outpatient clinic at 1 week, 4 weeks and 6 months after surgery and yearly thereafter. The mean time until recurrence was 18 months (range 2–42 months) in the 58 patients, who had undergone a procedure for prolapse and haemorrhoids (PPH), and 12 months (range 2–42 months) in those who had undergone a DSPPH. The clinical onset of recurrence and the operations chosen are shown in Table 1. In the group of patients treated with PPH or DSPPH, bleeding requiring surgical revision occurred in one patient. Minor bleeding, managed with a local haemostatic device, was reported by one patient. In the patients treated with surgical excision, instead, bleeding occurred in one patient and required surgical revision. Urgency (n = 2) and anal pain (n = 2), which occurred in patients in both groups, spontaneously disappeared after surgery. In the patients who underwent surgical excision combined with PPH, no bleeding, urgency or persisting anal pain occurred. The mean follow-up after reoperative surgery lasted 40 months (range 23–96 months). No cases of second recurrence occurred. In the case of a mobile prolapse, this may be resected with stapler (PPH or DSPPH, depending on the amount of the prolapse that needs to be resected). On the contrary, in the case of a fixed prolapse, one or two piles, the choice should be surgical excision. In case of more than three multiple piles (C3), transrectal resection with a stapler (PPH or DSPPH) may be used. A PPH combined with Milligan–Morgan haemorrhoidectomy should be applied in & D. Pironi danielepironi@gmail.com

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.

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.

This prospective, multicenter trial was designed to assess the safety and effectiveness of a novel technique in the treatment of outlet obstruction caused by the combination of intussusception and rectocele by using a double-transanal, 33-mm circular stapler. From January to October 2001, 90 patients with outlet obstruction were operated on and followed (mean, 16.3 ± 2.9 months) by the validated Constipation Scoring and Continence Grading Systems, clinical examination, defecography, and anorectal manometry. Anal ultrasound also was performed in 58 multiparous patients. Operative time and hospital stay were short (mean, 43.3 ± 8.7 minutes and 2.1 ± 0.8 days, respectively), and postoperative pain was minimal. The mean time to resume normal activity was 10.2 ± 4.5 days. Complications were 17.8 percent fecal urgency, 8.9 percent incontinence to flatus, 5.5 percent urinary retention, 4.4 percent bleeding, 3.3 percent anastomotic stenosis, and 1.1 percent pneumonia. All constipation symptoms significantly improved (P < 0.001) without worsening of anal continence. No patient complained of dyspareunia. At postoperative defecography, all patients had a double incisure of the lower rectal outline in the site of anastomosis, with the disappearance of both intussusception and rectocele. Anal pressure was not significantly modified, whereas rectal compliance was restored (P < 0.05). No lesions of anal sphincters caused by the operation were found in multiparous patients. The outcome at one year was excellent in 48 of 90 patients, good in 33, fairly good in 5, and poor in 4. This novel technique seems to be safe and effective in the treatment of outlet obstruction caused by the combination of intussusception and rectocele. Randomized trials are required to confirm these findings.