Analysis of factors that indicated surgery in 400 patients submitted to a complete diagnostic workup for obstructed defecation syndrome and rectal prolapse using a supervised machine learning algorithm.

BACKGROUND: Patient selection is extremely important in obstructed defecation syndrome (ODS) and rectal prolapse (RP) surgery. This study assessed factors that guided the indications for ODS and RP surgery and their specific role in our decision-making process using a machine learning approach. METHODS: This is a retrospective analysis of a long-term prospective observational study on female patients reporting symptoms of ODS who underwent a complete diagnostic workup from January 2010 to December 2021 at an academic tertiary referral center. Clinical, defecographic, and other functional tests data were assessed. A supervised machine learning algorithm using a classification tree model was performed and tested. RESULTS: A total of 400 patients were included. The factors associated with a significantly higher probability of undergoing surgery were follows: as symptoms, perineal splinting, anal or vaginal self-digitations, sensation of external RP, episodes of fecal incontinence and soiling; as physical examination features, evidence of internal and external RP, rectocele, enterocele, or anterior/middle pelvic organs prolapse; as defecographic findings, intra-anal and external RP, rectocele, incomplete rectocele emptying, enterocele, cystocele, and colpo-hysterocele. Surgery was less indicated in patients with dyssynergia, severe anxiety and depression. All these factors were included in a supervised machine learning algorithm. The model showed high accuracy on the test dataset (79%, p < 0.001). CONCLUSIONS: Symptoms assessment and physical examination proved to be fundamental, but other functional tests should also be considered. By adopting a machine learning model in further ODS and RP centers, indications for surgery could be more easily and reliably identified and shared.

Technical modifications for cost optimization in robot-assisted ventral mesh rectopexy: an initial experience.

BACKGROUND: Robot-assisted ventral mesh rectopexy is considered a valid option in the treatment of rectal prolapse. However, it involves higher costs than the laparoscopic approach. The aim of this study is to determine if less expensive robotic surgery for rectal prolapse can be safely performed. METHODS: This study was conducted on consecutive patients who underwent robot-assisted ventral mesh rectopexy at Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, from 7 November 2020 to 22 November 2021. The cost of hospitalization, surgical procedure, robotic materials, and operating room resources in patients undergoing robot-assisted ventral mesh rectopexy with the da Vinci Xi Surgical Systems was analyzed before and after technical modifications, including the reduction of robotic arms and instruments, and the execution of a double minimal peritoneal incision at the pouch of Douglas and sacral promontory (instead of the traditional inverted J incision). RESULTS: Twenty-two robot-assisted ventral mesh rectopexies were performed [21 females, 95.5%, median age 62.0 (54.8-70.0) years]. After an initial experience performing traditional robot-assisted ventral mesh rectopexy in four patients, we adopted technical modifications in other cases. No major complication or conversion to open surgery occurred. In total, mean cost of hospitalization, surgical procedure, robotic materials, and operating room resources was €6995.5 ± 1058.0, €5912.7 ± 877.0, €2797.6 ± 545.6, and €2608.3 ± 351.5, respectively. Technical modifications allowed a significant reduction in the overall cost of hospitalization (€6604.5 ± 589.5 versus €8755.0 ± 906.4, p = 0.001), number of robotic instruments (3.1 ± 0.2 versus 4.0 ± 0.8 units, p = 0.026), and operating room time (201 ± 26 versus 253 ± 16 min, p = 0.003). CONCLUSIONS: Considering our preliminary results, robot-assisted ventral mesh rectopexy with appropriate technical modifications can be cost-effective and safe.

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.

Haemorrhoidal haemodynamic changes in patients with haemorrhoids treated using Doppler-guided dearterialization.

BACKGROUND: Arterial hyperflow to haemorrhoids has been implicated as a possible pathophysiological co-factor in haemorrhoidal disease. The purpose of this study was to investigate how transanal haemorrhoidal dearterialization (THD) can influence haemodynamic parameters at the level of the haemorrhoidal piles. METHODS: Patients with grade III haemorrhoids selected for THD between July and December 2018 were evaluated using endoanal ultrasonography and colour Doppler imaging at the level of internal haemorrhoids before and 1 year after the surgical procedure. Peak systolic velocity, pulsatility index, resistivity index, acceleration time, and end-diastolic velocity were measured, and preoperative and postoperative values compared. Symptom severity was measured using a symptom-based questionnaire (score range 0-20). RESULTS: Of 21 patients treated, 17 completed the study. Compared with preoperative values, postoperative peak systolic velocity (mean(s.d.) 18.7(1.1) versus 10.3(0.4) cm/s; P < 0.05), pulsatility index (5.5(0.3) versus 2.8(0.4); P < 0.050), and resistivity index (1.0(0.2) versus 0.8(0.5); P < 0.050) decreased significantly, whereas acceleration time increased significantly (65.6(3.6) versus 83.3(4.7) cm/s2; P < 0.050); end-diastolic velocity did not change (1.9(0.2) versus 2.0(0.4); P = 0.753). Symptoms disappeared or had improved significantly in all patients by 1 year after surgery. The mean(s.d.) total symptom severity score decreased from 15.8(1.1) to 1.2(1.6) (P < 0.001). CONCLUSION: THD affects the main haemodynamic parameters at the level of internal haemorrhoids and is associated with a decrease in arterial hyperflow.

Simple fistula-in-ano: is it all simple? A systematic review.

BACKGROUND: Simple anal fistula is one of the most common causes of proctological surgery and fistulotomy is considered the gold standard. This procedure, however, may cause complications. The aim of this systematic review was to assess the surgical treatment of simple anal fistula with traditional and sphincter-sparing techniques. METHODS: A literature research was performed using PubMed, Cochrane, and Google Scholar to identify studies on the surgical treatment of simple anal fistulas. Observational studies and randomized clinical trials were included. We assessed the risk of bias of included studies using the Jadad scale for randomized controlled trials, and the MINORS Scale for the remaining studies. RESULTS: The search returned 456 records, and 66 studies were found to be eligible. The quality of the studies was generally low. A total of 4883 patients with a simple anal fistula underwent a sphincter-cutting procedure, mainly fistulotomy, with a weighted average healing rate of 93.7%, while any postoperative continence impairment was reported in 12.7% of patients. Sphincter-sparing techniques were adopted to treat 602 patients affected by simple anal fistula, reaching a weighted average success rate of 77.7%, with no study reporting a significant postoperative incontinence rate. The postoperative onset of fecal incontinence and the recurrence of the disease reduced patients' quality of life and satisfaction. CONCLUSIONS: Surgical treatment of simple anal fistulas with sphincter-cutting procedures provides excellent cure rates, even if postoperative fecal incontinence is not a negligible risk. A sphincter-sparing procedure could be useful in selected patients.

Management of hemorrhoidal disease: new generation of oral and topical treatments.

Hemorrhoidal disease is a widespread proctologic clinical entity. Even if surgical excision is an effective treatment, it only represents the standard procedure for patients with high-grade hemorrhoids. Considering that most cases are grade I or II hemorrhoids, oral or topical therapies are widely used despite, currently, there are no satisfactory options for these kinds of treatments. The pathology involves the degeneration of the supporting tissue of the anal cushions, causing venous dilation, blood stagnation, formation of edematous venous plexus covered by mucosa and inflammation. An effective treatment must, therefore, be multi-targeted and capable of acting on all the pathological mechanisms simultaneously. During the 8th National Congress of the Italian Association of Colorectal Surgery (SICCR), some clinical evidence of hemorrhoidal disease has been discussed along with new opportunities in oral and topical treatment options. Among these, the effectiveness and the safety of two innovative products, a sublingual nanoemulsion and a liquid bandage, has been reported.

Laparoscopic sacrocolpopexy plus ventral rectopexy as combined treatment for multicompartment pelvic organ prolapse.

BACKGROUND: Pelvic organ prolapse (POP) is a dynamic disorder that affects the entire pelvic diaphragm. POP may often involve multiple organs. Abdominal sacrocolpopexy is considered the gold standard to treat female anterior and apical prolapse. Abdominal ventral mesh rectopexy has gained increasing acceptance as an effective treatment for rectal prolapse. The aim of the present study was to assess the safety, feasibility and 1-year outcomes of laparoscopic sacrocolpopexy plus ventral rectopexy as a combined treatment of multicompartment POP. METHODS: All female patients at our institution with anterior and apical prolapse with symptoms of obstructed defecation were examined by an urogynecologist and a colorectal surgeon, and were judged suitable for the study. Patients with Pelvic Organ Prolapse Quantification (POP-Q) system stage III and IV and concomitant rectal prolapse were treated by laparoscopic sacrocolpopexy plus ventral rectopexy. After surgery, 1- and 12-month follow-up was performed and the data were retrospectively analyzed. Patients' symptoms were evaluated using the Female Sexual Distress Scale (FSDS), Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12), and Wexner-Agachan constipation score. RESULTS: A total of 98 patients underwent surgery. No intraoperative or postoperative morbidity occurred. At the time of follow-up, all women expressed great satisfaction with the surgical treatment: all the patients had at most POP-Q Stage 1 and 78.8% had a Patient Global Impression of Improvement (PGI-I) score < 3. Significant improvement of symptoms related to POP and to obstructed defecation syndrome, as shown by the FSDS, PISQ-12, and Wexner-Agachan constipation score, was observed in all patients at follow-up CONCLUSIONS: Laparoscopic sacrocolpopexy with ventral rectopexy is a feasible and safe procedure for the combined surgical management of anterior, apical, and posterior prolapse, and provides excellent objective and subjective outcomes.

Efficacy of Sphinkeeper™ implant in treating faecal incontinence.

The primary aim of this prospective study was to assess the efficacy of Sphinkeeper™ (SK) implantation in patients with faecal incontinence. Forty-two patients with faecal incontinence (14 with sphincter defects) underwent SK implantation and were followed up for a mean(s.d.) of 15·9(8·6) months. SK implantation was a safe and effective method that improved patients' quality of life. Implants and incontinence.

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.

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.

Immunopathological characterization of cryptoglandular anal fistula: a pilot study investigating its pathogenesis.

AIM: The pathogenesis of cryptoglandular anal fistula (AF) is still under debate. Tissue inflammation could play a primary role. The pathological process of epithelial mesenchymal transition (EMT) might be involved but has never been investigated. METHOD: In a prospective pilot study, 12 patients with an AF had a fistulectomy. The excised track was divided into proximal (intrasphincteric) and distal (extrasphincteric) parts which were subjected to standard histopathological examination. The cytokines IL-8 and IL-1beta were analysed as markers of inflammation, while EMT was evaluated by expression of TGF-beta, Vimentin, Zeb-1, Snail and E-cadherin. The mRNA and protein expression of these molecules was investigated by real-time PCR (RT-PCR), Western blot analysis and immunohistochemistry and was compared with that of the normal adjacent tissue. RESULTS: Chronic inflammation and granulation tissue and a stratified epithelium were evident on standard histopathological examination. The cytokine IL-8 was more expressed in the proximal than the distal part of the track (fold increase 4.34 vs 3.60), while the reverse was found for IL-1beta (fold increase 1.33 vs 2.01); both were more intensely expressed compared with the normal anal mucosa. EMT was demonstrated, in both proximal and distal parts of the track, with an increase of TGF-beta, Vimentin, Zeb-1 and Snail and a mean decrease of E-cadherin. Western blot analysis and immunohistochemistry confirmed the protein expression. CONCLUSION: The study suggests that chronic inflammation is present in cryptoglandular fistulas. The inflammatory pattern might be different in the proximal than in the distal part of the fistula track. The cytokines IL-1beta and IL-8 could play a possible role in fistula formation. The study demonstrates for the first time the potential importance of EMT in the pathogenesis of cryptoglandular AF.

Multicentre observational study of the Gatekeeper for faecal incontinence.

BACKGROUND: A variety of therapeutic approaches are available for faecal incontinence. Implantation of Gatekeeper prostheses is a new promising option. The primary endpoint of this prospective observational multicentre study was to assess the clinical efficacy of Gatekeeper implantation in patients with faecal incontinence. Secondary endpoints included the assessment of patients' quality of life, and the feasibility and safety of implantation. METHODS: Patients with faecal incontinence, with either intact sphincters or internal anal sphincter lesions extending for less than 60° of the anal circumference, were selected. Intersphincteric implantation of six prostheses was performed. At baseline, and 1, 3 and 12 months after implantation, the number of faecal incontinence episodes, Cleveland Clinic Faecal Incontinence, Vaizey and American Medical Systems, Faecal Incontinence Quality of Life Scale and Short Form 36 Health Survey scores were recorded. Endoanal ultrasonography was performed at baseline and follow-up. RESULTS: Fifty-four patients were implanted. After Gatekeeper implantation, incontinence to gas, liquid and solid stool improved significantly, soiling was reduced, and ability to defer defaecation enhanced. All faecal incontinence severity scores were significantly reduced, and patients' quality of life improved. At 12 months, 30 patients (56 per cent) showed at least 75 per cent improvement in all faecal incontinence parameters, and seven (13 per cent) became fully continent. In three patients a single prosthesis was extruded during surgery, but was replaced immediately. After implantation, prosthesis dislodgement occurred in three patients; no replacement was required. CONCLUSION: Anal implantation of the Gatekeeper in patients with faecal incontinence was effective and safe. Clinical benefits were sustained at 1-year follow-up.