Collagen treatment of complex anorectal fistula: 3 years follow-up.

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.

Data on correction of pelvic organ prolapse by laparoscopic lateral suspension with mesh: A clinical series.

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.

Correction of pelvic organ prolapse by laparoscopic lateral suspension with mesh: A clinical series.

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.

Stapled trans-anal rectal resection (STARR) in the surgical treatment of the obstructed defecation syndrome: results of STARR Italian Registry.

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 56.2 years; 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.

Outcomes of stapled transanal rectal resection vs. biofeedback for the treatment of outlet obstruction associated with rectal intussusception and rectocele: a multicenter, randomized, controlled trial.

PURPOSE: This study was designed to assess the safety and outcomes achieved with stapled transanal rectal resection vs. biofeedback training in obstructed defecation patients. METHODS: 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. RESULTS: 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 P < 0.0001). Successful treatment was observed in 44 (81.5 percent) stapled transanal rectal resection vs. 13 (33.3 percent) evaluable biofeedback training patients (P < 0.0001). Functional benefit was observed early and remained stable during the study. CONCLUSIONS: 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.

Decision-making algorithm for the STARR procedure in obstructed defecation syndrome: position statement of the group of STARR Pioneers.

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.

Stapled transanal rectal resection for outlet obstruction: a prospective, multicenter trial.

PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.