Predictive factors for functional failure of ventral mesh rectopexy in the treatment of rectal prolapse and obstructed defecation.

BACKGROUND: Ventral mesh rectopexy (VMR) is widely accepted for the treatment of rectal prolapse or obstructed defecation. However, despite good anatomical results, the improvement of functional symptoms (constipation or incontinence) cannot always be obtained and in some cases these symptoms may even worsen. The aim of the present study was to identify possible predictors of functional failure after VMR. METHODS: Data of all consecutive patients who had VMR for the treatment of rectal prolapse and/or obstructed defecation between January 2017 and December 2020 in three different pelvic floor surgical centres in Italy were analysed to identify possible predictors of functional failure, intended as persistence, worsening or new onset of constipation or faecal incontinence. Symptom severity was assessed pre- and postoperatively with the Wexner Constipation score and Obstructed Defecation Syndrome score. Quality of life was assessed, also before and after treatment, with the Patients Assessment of Constipation Quality of Life questionnaire, the Pelvic Floor Disability Index and the Pelvic Floor Impact Questionnaire. Faecal incontinence was evaluated with the Cleveland Clinic Incontinence Score. The functional outcomes before and after surgery were compared. RESULTS: Sixty-one patients were included (M:F ratio 3:60, median age 64 years [range 33-88 years]). Forty-two patients (68.9%) had obstructed defecation syndrome, 12(19.7%) had faecal incontinence and 7 patients (11.5%) had both. A statistically significant reduction between pre- and postoperative Obstructed Defecation Syndrome and Wexner scores was reported (p < 0.0001 in both cases). However, the postoperative presence of constipation occurred in 22 patients (36.1%) (this included 3 cases of new-onset constipation). The presence of redundant colon and the pre-existent constipation were associated with an increased risk of persistence of constipation postoperatively or new-onset constipation (p = 0.004 and p < 0.0001, respectively). The use of postoperative pelvic floor rehabilitation (p = 0.034) may reduce the risk of postoperative constipation. CONCLUSIONS: VMR is a safe and effective intervention for correcting the anatomical defect of rectal prolapse. The degree of prolapse, the presence of dolichocolon and pre-existing constipation are risk factors for the persistence or new onset of postoperative constipation. Postoperative rehabilitation treatment may reduce this risk.

A multicentre, open-label, single-arm phase II trial of the efficacy and safety of sclerotherapy using 3% polidocanol foam to treat second-degree haemorrhoids (SCLEROFOAM).

BACKGROUND: The aim of the present study was to evaluate the efficacy and safety of 3% polidocanol foam for treating 2nd-degree haemorrhoids. METHODS: A multicentre, open-label, single-arm, phase 2 trial involving 10 tertiary referral centres for haemorrhodal disease (HD) was performed. Between January and June 2019, patients with 2nd-degree haemorrhoids were prospectively included in this study. The primary outcome was to establish the success rate after one sclerotherapy session in terms of complete resolution of bleeding episodes one week after the injection. The Hemorrhoidal Disease Symptom Score (HDSS), the Short Health Scale for HD (SHS-HD) score and the Vaizey incontinence score were used to assess symptoms and their impact on quality of life and continence. Pain after the procedure, subjective symptoms and the amount and type of painkillers used were recorded. Patients were followed up for 1 year. RESULTS: There were 183 patients [111 males; 60.7%, mean age 51.3 ± 13.5 (18-75) years]. Complete resolution of bleeding was reached in 125/183 patients (68.3%) at 1 week and the recurrence rate was 12% (15/125). Thirteen patients (7.4%) underwent a second sclerotherapy session, while only 1 patient (1.8%) had to undergo a third session. The overall 1-year success rate was 95.6% (175/183). The HDSS and the SHS score significantly improved from a median preoperative value of 11 and 18 to 0 and 0, respectively (p < 0.001). There were 3 episodes of external thrombosis. No serious adverse events occurred. CONCLUSIONS: Sclerotherapy with 3% polidocanol foam is a safe, effective, painless, repeatable and low-cost procedure in patients with bleeding haemorrhoids.

Pelvic floor rehabilitation for defecation disorders.

Pelvic floor rehabilitation is frequently recommended for defecation disorders, in both constipation and fecal incontinence. However, the lack of patient selection, together with the variety of rehabilitation methods and protocols, often jeopardize the results of this approach, causing difficulty in evaluating outcomes and addressing proper management, and above all, in obtaining scientific evidence for the efficacy of these methods for specific indications. The authors represent different gastroenterological and surgical scientific societies in Italy, and their aim was to identify the indications and agree on treatment protocols for pelvic floor rehabilitation of patients with defecation disorders. This was achieved by means of a modified Delphi method, utilizing a working team (10 members) which developed the statements and a consensus group (15 members, different from the previous ones) which voted twice also suggesting modifications of the statements.

Surgical management of haemorrhoids: an Italian survey of over 32 000 patients over 17 years.

AIM: The management of haemorrhoids has changed significantly in the last two decades as a result of new insights into their pathophysiology and the availability of new surgical devices. The aim of this survey was to evaluate changes in the management of haemorrhoids in Italy over the last 17 years. METHOD: An electronic database which recorded details of management relating to the severity of haemorrhoids between 2000 and 2016 was obtained from 18 of 34 colorectal surgeons who were invited to participate. RESULTS: A total of 32 458 patients were treated for haemorrhoids by 18 expert coloproctologists during a 17-year period. Patients were classified as Grade II (7542, 23.2%), Grade III(15 360, 47.3%) and Grade IV (9556, 29.4%). Grade II haemorrhoids were treated with rubber band ligation in over 90% of the cases, and patients with Grade IV had a Milligan-Morgan (MM) haemorrhoidectomy in over 90% of the cases. In Grade III, the use of stapled haemorrhoidopexy progressively decreased from 30% to 35% (between 2000 and 2007) to 5% of the cases. Meanwhile, commencing from 2006 the use of Doppler-guided haemorrhoid artery ligation (DGHAL) with mucopexy increased progressively from 6% to 24%. Over the years, the percentage of MM haemorrhoidectomy remained consistent at between 65% and 70% of the cases. CONCLUSION: Relevant changes in the surgical choice of haemorrhoid treatment have occurred in Italy over the last 17 years. MM haemorrhoidectomy remains the most frequently performed procedure for Grade III haemorrhoids. Stapled haemorrhoidopexy has become much less popular in contrast to DGHAL with mucopexy which is being performed much more frequently.

Micro-fragmented adipose tissue injection for the treatment of complex anal fistula: a pilot study accessing safety and feasibility.

BACKGROUND: The aim of the present study was to evaluate the safety and efficacy of autologous, micro-fragmented and minimally manipulated adipose tissue injection associated closure of the internal opening in promoting healing of complex anal fistula. METHODS: A pilot study was conducted on patients referred to our center with anal fistula, from April 2015-December 2016. Inclusion criteria were age over 16 years old and a diagnosis of complex anal fistula according to the American Gastroenterological Association classification The patients were divided into 2 groups; the "first time group" (Group I) in which micro-fragmented adipose tissue injection with closure of the internal opening was the first sphincter-saving procedure, and the "recurrent group" (Group II) consisting of patients who had failed prior sphincter-saving procedures. The procedure was carried out 4-6 weeks after seton placement. Follow-up visits were scheduled at 7 days, and 1, 3, 6 and 12 months after surgery. Fistula healing was defined as the closure of the internal and external openings without any discharge. RESULTS: Out of 47 patients with complex transsphincteric anal fistula, 19 met the inclusion criteria and were selected to undergo the procedure. Twelve of these patients (Group I) had micro-fragmented adipose tissue injection as first-line treatment, and 7 (Group II) had failed previous sphincter-saving procedures. The mean operative time was 55 ± 6 min (range 50-70 min). The mean postoperative pain score measured with the visual analog pain scale was 2 ± 1.4 (range 0-4). No intraoperative difficulties related to the use of the kit were recorded. There were no cases of postoperative fever or abdominal sepsis related to the procedure and no post-treatment perianal bleeding or impaired anal continence. Only 3 cases of minor abdominal wall hematoma that did not require any treatment and 1 case of perianal abscess were observed. Patients were evaluated for a mean follow-up time of 9 ± 3.1 months (range 3-12 months). The overall healing rate was 73.7, 83.3% for Group I and 57.1% for Group II. CONCLUSIONS: The injection of autologous, micro-fragmented and minimally manipulated adipose tissue associated with closure of the internal opening is a safe, feasible and reproducible procedure and may enhance complex anal fistula healing.

Treatment of obstructed defecation syndrome due to rectocele and rectal intussusception with a high volume stapler (TST STARR-plus).

BACKGROUND: In recent years, stapled transanal resection (STARR) has been adopted worldwide with convincing short-term results. However, due to the high recurrence rate and some major complications after STARR, there is still controversy about when the procedure is indicated. The aim of this study was to assess the safety, efficacy and feasibility of STARR performed with a new dedicated device for tailored transanal stapled surgery. METHODS: All the consecutive patients affected by obstructed defecation syndrome (ODS) due to rectocele or/and rectal intussusception, who underwent STARR with the TST STARR-Plus stapler, were included in a prospective study. Pain, Cleveland Clinic Score for Constipation (CCCS) and incontinence, patient satisfaction, number of hemostatic stitches, operative time, hospital stay and perioperative complications were recorded. Postoperative complications and recurrence were also reported. RESULTS: Forty-five consecutive patients (median age 50; range 24-79) were included in the study. Median resected volume was 15 cm3 (range 12-19 cm3) with a median height of surgical specimen of 5.6 cm (range 4.5-10 cm). The mean CCCS decreased from 17.26 (± 3.77) to 5.42 (± 2.78) postoperatively (p < 0.001). Patient satisfaction grade was excellent in 14 patients (31.1%), good in 25 (55.5%), sufficient in three (6.7%) and poor in three patients (6.7%). No major complications occurred. Five patients (11%) reported urgency after 30 days and two patients (4%) after 12 months. The Cleveland Clinic Incontinence score did not significantly change. At a median follow-up of 23 months (range 12-30 months), only three patients (6.7%) reported recurrent symptoms of obstructed defecation comparable to those reported at baseline. CONCLUSIONS: TST STARR-Plus seems to be safe and effective for the treatment of ODS due to rectocele and rectal intussusception, and technical improvement could reduce the risk of some complications. However, careful patient selection is still the best means of preventing complications.

Long-term results after stapled hemorrhoidopexy: a survey study with mean follow-up of 12 years.

BACKGROUND: Hemorrhoidal prolapse is a common benign disease. The introduction of circular-stapled hemorrhoidopexy as an alternative to the conventional hemorrhoidectomy led to a new spectrum of postoperative outcomes and complications. The aim of the present study was to evaluate long-term results after stapled hemorrhoidopexy. METHODS: All the patients who had stapled hemorrhoidopexy using a PPH03 stapler, from January 2003 to December 2005, were retrospectively collected in a dedicated database. Between March and May 2016, all the patients were asked by phone to complete a questionnaire. The study evaluated anatomical recurrence, symptom recurrence and frequency, and satisfaction after surgery. The postoperative complications recorded were hemorrhage, hematoma, urinary retention, anastomotic stenosis, persistent anal pain, tenesmus, and impaired anal continence evaluated also with the Faecal Incontinence Severity Index score. RESULTS: One hundred and ninety four patients were identified and 171 completed the questionnaire. The mean follow-up was 12 ± 0.8 years (range 11-13 years). Anatomical self-reported prolapse recurrence was 40.9% (n = 70). In 75.6% (n = 129) of patients, the severity and frequency of symptoms improved. The overall complication rate was 56.7% (n = 40) with a serious adverse event rate of 8.7% (n = 15). The overall tenesmus rate was 38.2% (n = 65) and the overall impaired continence rate was 39.1% (n = 67). Medical therapy was still required occasionally by 40.3% (n = 69) of the patients and 9.3% (n = 16) of the patients underwent surgery for recurrence. Patient satisfaction rate was good (≥ 3 on a scale of 1 to 5) in 81.2% (n = 139) of cases. CONCLUSIONS: The study showed that stapled hemorrhoidopexy using the first-generation devices is safe and feasible but associated with a high recurrence and incontinence rate. More stringent selection criteria in association with the use of large volume devices can lead to better results in the future.

Correction to: Long-term results after stapled hemorrhoidopexy: a survey study with mean follow-up of 12 years.

Unfortunately, the 7th author's family name was incorrectly published in the original publication. The complete correct name should read as follows.

Permacol™ collagen paste injection for the treatment of complex anal fistula: 1-year follow-up.

BACKGROUND: Optimal surgical treatment for anal fistula should result in healing of the fistula track and preserve anal continence. The aim of this study was to evaluate Permacol™ collagen paste (Covidien plc, Gosport, Hampshire, UK) injection for the treatment of complex anal fistulas, reporting feasibility, safety, outcome and functional results. METHODS: Between May 2013 and December 2014, 21 consecutive patients underwent Permacol paste injection for complex anal fistula at our institutions. All patients underwent fistulectomy and seton placement 6-8 weeks before Permacol™ paste injection. Follow-up duration was 12 months. RESULTS: Eighteen patients (85.7%) had a high transsphincteric anal fistula, and three female patients (14.3%) had an anterior transsphincteric fistula. Fistulas were recurrent in three patients (14.3%). Seven patients (33%) had a fistula with multiple tracts. After a follow-up of 12 months, ten patients were considered healed (overall success rate 47.6%). The mean preoperative FISI score was 0.33 ± 0.57 and 0.61 ± 1.02 after 12 months. CONCLUSIONS: Permacol™ paste injection was safe and effective in some patients with complex anal fistula without compromising continence.

Obstructed defaecation syndrome: European consensus guidelines on the surgical management.

Clinical decision-making in the treatment of patients with obstructed defaecation remains controversial and no international guidelines have been provided so far. This study reports a consensus among European opinion leaders on the management of obstructed defaecation in different possible clinical scenarios.

Tailored prolapse surgery for the treatment of hemorrhoids with a new dedicated device: TST Starr plus.

PURPOSE: The aim of the study was to assess the results of the stapled transanal procedure in the treatment of hemorrhoidal prolapse in terms of postoperative complications and recurrence rate using a new dedicated device, TST Starr plus. METHODS: Patients affected by III-IV degree hemorrhoidal prolapsed that underwent stapled transanal resection with the TST Starr plus were included in the present study. Results of the procedure with perioperative complications, postoperative complications, and recurrence rate were reported. RESULTS: From November 2012 to October 2014, 52 patients (19 females) were enrolled in the study. The main symptoms were prolapse (100 %) and bleeding (28.8 %). Transanal rectal resection was performed with parachute technique in 24 patients (46.2 %) and purse string technique in 23 patients (53.8 %). A mild hematoma at the suture line occurred in one patient (1.9 %). Postoperative bleeding was reported in three patients (5.7 %), in one of which, reoperation was necessary (1.9 %). Tenesmus occurred in one patient (1.9 %), and it was resolved with medical therapy. Urgency was reported in nine patients (17.1 %) at 7 days after surgery. Of these, three patients (5.7 %) complained urgency at the median follow-up of 14.5 months. Reoperation was performed in one patient (1.9 %) for chronic anal pain for rigid suture fixed on the deep plans. Occasional bleeding was reported in four patients (7.7 %). No recurrence of prolapse was reported at a median of 14.5 months after surgery, even if one patient (1.9 %) had a partial recurrent prolapse of a downstaged single pile. CONCLUSIONS: TST Starr plus seems to be safe and effective for a tailored transanal stapled surgery for the treatment of III-IV degree hemorrhoidal prolapse. The new conformation and innovative technology of the stapler seems to reduce some postoperative complications and recurrence rate.

Long-term results following sacral nerve stimulation for chronic constipation.

AIM: The long-term outcome of sacral nerve stimulation (SNS) for chronic functional constipation was assessed. METHOD: Patients who received a definitive SNS implant for chronic functional constipation only (according to the Rome III criteria) and were followed up for at least 3 years were included in this study. Slow transit constipation (STC) was distinguished from obstructed defaecation (OD) and mixed/undetermined constipation (MU). Constipation features, Cleveland Clinic Constipation score (CCCS) and SF-36 questionnaire data were collected; physiological tests were performed. RESULTS: Forty-two out of 61 patients suitable for SNS received a definitive implant (14 for STC, 15 for OD, 13 for MU). Following SNS device implantation (mean follow-up 51 ± 15 months), the baseline CCCS (17 ± 6) dropped to 9 ± 6 (P < 0.001) and 47% of patients had an improvement in the CCCS of more than 50%. Such improvement was more significant in patients with OD. Anal pressures did not change, while threshold and urgency rectal sensation significantly decreased, in particular in patients with OD. All aspects of patients' health status (SF-36) improved significantly following SNS; this was more marked in patients with OD. CONCLUSION: Data from this study suggest that the clinical efficacy of SNS can be prolonged in constipated patients, but in both the preliminary diagnostic assessment and pathophysiological interpretation every effort should be made to select patients for SNS. Although SNS showed efficacy in a low percentage of patients with STC, patients with OD were more responsive.

Sacral neuromodulation for bowel dysfunction: a consensus statement from the Italian group.

BACKGROUND: Representatives from the Italian centers experienced in sacral neuromodulation (SNM) for the treatment of bowel dysfunction met in order to define the current clinical practice in Italy and to produce a consensus statement regarding indications for this therapy and patient management. METHODS: Fifty Italian colonproctologists were asked to complete a questionnaire concerning their clinical practice in SNM (290 questions, grouped within 4 broad areas). Physicians expressed their opinion by completing the questionnaire, assigning to each statement their level of agreement according to the 5-point Likert scale; the data were analyzed by attributing to each expert's answers a weight proportional to the degree of experience. During a meeting held 2 months later, the critical aspects of the therapy were re-examined and discussions held with the goal of reaching an agreement on controversial topics. The available literature was reviewed. RESULTS: Patient selection criteria, etiology, diagnostic investigations, test procedures and implantation, follow-up and evaluation of results have been reviewed. The aim was to achieve an algorithm for patient management, showing the place of SNM in the treatment of bowel dysfunction. The approach in case of treatment failure was also discussed. CONCLUSIONS: Analysis of the data collected reveals substantial consensus at the national level concerning all the main points with regard to the therapy. The recommendations expressed in this article can be considered as national guidelines and taken into account by the principal international implantation centers.

Sacral nerve modulation in the treatment of chronic pelvic pain.

BACKGROUND: Chronic pelvic pain is a common condition that significantly compromises the quality of life of affected patients. Unfortunately, despite treatment procedures, the results are often ineffective and symptoms persist for years. For these reasons, the search for less aggressive treatment options with fewer negative consequences leading to minimally invasive techniques was conducted. OBJECTIVE: The aim of the present study was to evaluate the efficacy of sacral nerve modulation in the treatment of chronic pelvic pain. Moreover, we aimed to identify potential predictors of positive results of sacral neuromodulation through the comparison between failed and successful patients. PATIENTS: From January 2004 to December 2009, all consecutive patients suffering from chronic pelvic pain and tested for sacral nerve modulation in three pelvic floor dedicated centers were evaluated. Severity of symptoms were analyzed by a visual analog scale (VAS) RESULTS: Twenty-seven patients (2 males; mean age, 53 years) were tested for sacral nerve modulation in the screening period and were included in the present study. The mean duration of pain was 51 months (range, 10-132 months). The mean preoperative VAS was 7.8 (range, 5-10). Previous pelvic surgery was reported in 18 patients (66.5%). Sixteen patients (59%) fulfil the successful criteria and were definitively implanted. The mean follow-up was 37 months (range, 12-71 months). The mean preoperative VAS was 8.1 (range, 6-8) and decreased to 2.1 ± 1.2 at 6-month follow-up (p < 0.0001), to 2.1 ± 1.1 at 12 months (16 patients), to 2.0 ± 1.2 at 24 months (13 patients), to 2.3 ± 1.4 at 36 months (9 patients), to 2.1 ± 1.5 at 48 months (5 patients), and to 1.9 ± 1.3 at 60 months (3 patients). CONCLUSIONS: Sacral neuromodulation proved to be effective in the treatment of some patients affected by chronic pelvic pain, and the effect persists over time. A positive screening phase and a positive response to gabapentin or pregabalin showed to be predictors of a successful response. Multiple localizations of pelvic pain and pain occurred after stapler surgery seem to be negative factors for the success of the treatment.