The Italian Unitary Society of Colon-proctology (SIUCP: Società Italiana Unitaria di Colonproctologia) guidelines for the management of anal fissure.

INTRODUCTION: The aim of these evidence-based guidelines is to present a consensus position from members of the Italian Unitary Society of Colon-Proctology (SIUCP: Società Italiana Unitaria di Colon-Proctologia) on the diagnosis and management of anal fissure, with the purpose to guide every physician in the choice of the best treatment option, according with the available literature. METHODS: A panel of experts was designed and charged by the Board of the SIUCP to develop key-questions on the main topics covering the management of anal fissure and to performe an accurate search on each topic in different databanks, in order to provide evidence-based answers to the questions and to summarize them in statements. All the clinical questions were discussed by the expert panel in different rounds through the Delphi approach and, for each statement, a consensus among the experts was reached. The questions were created according to the PICO criteria, and the statements developed adopting the GRADE methodology. CONCLUSIONS: In patients with acute anal fissure the medical therapy with dietary and behavioral norms is indicated. In the chronic phase of disease, the conservative treatment with topical 0.3% nifedipine plus 1.5% lidocaine or nitrates may represent the first-line therapy, eventually associated with ointments with film-forming, anti-inflammatory and healing properties such as Propionibacterium extract gel. In case of first-line treatment failure, the surgical strategy (internal sphincterotomy or fissurectomy with flap), may be guided by the clinical findings, eventually supported by endoanal ultrasound and anal manometry.

Topical treatment of anal condylomata with Propionibacterium acnes lysate: results of a multicentric observational study.

BACKGROUND: Condylomata are a manifestation of HPV infection of the ano-genital epithelium. Recurrence is frequent after any type of treatment (from 20% up to 50%). We assessed the use of a gel containing panthenol, tocopheryl acetate and Propionibacterium extract in the treatment of anal warts. METHODS: Enrollment period was from January 15 to June 15, 2018. Main exclusion criteria were immunodepression, extensive condylomatosis and other treatments (topical/ablative) in the previous six months. RESULTS: Seventy-nine patients were included. Median age was 33 years (19-65), 72.2% were males. Median number of partners and symptoms duration were 6 (1-98) and 3 months (1-18), respectively. Almost all cases had perianal disease (97.5%), while endoanal warts were present in 51.9% of cases. After 30 days of treatment, complete regression occurred in 17 (21.5%) patients, while partial or absent response was reported in 36 (45.6%) and 26 (32.9%) cases, respectively. Forty-seven (59.5%) patients underwent a second month of topical therapy. After a 6-month follow-up, complete or partial response was reported in 53 (67.1%) patients, while in 26 (32.9%) cases the disease remained stable or even worsened. Nineteen (24.1%) patients required cryotherapy, 23 (29.1%) surgical excision, while 2 (2.5%) needed both cryotherapy and surgery. Absence of clinical response was associated with a number of partners ≥10 and symptoms duration of 6 months or shorter (P<0.001 and P=0.050). CONCLUSIONS: In our study, the gel containing P. acnes lysate was a safe topical treatment for perianal and endoanal condylomata and could help to overcome HPV infection. A high number of partners and short symptoms duration appeared to worsen the outcome.

A 10-year retrospective cohort study to assess objective and subjective outcomes of combined stapled transanal rectal resection and urogynecological surgery for pelvic floor dysfunction.

PURPOSE: To assess the subjective and objective outcomes of combined stapled transanal rectal resection (STARR) and urogynecological surgery to treat pelvic organ prolapse, with a 10-year follow-up. METHODS: This was a retrospective cohort study analyzing prospectively collected data from 53 consecutive patients who underwent combined stapled transanal rectal resection and urogynecological surgery, from 1 January 2005 to 31 December 2007 at a tertiary referral Pelvic Floor Unit of an Italian hospital. RESULTS: Fifty-three patients with a median age of 60 years (interquartile range (IQR) 67-52t), underwent STARR and concomitant urogynecological surgery. No serious postoperative complications were recorded, and 37/53 women (70%) were evaluated at the 10-year follow-up visit. The cure rate was optimal in 34 women (64.1%). Regarding persistent and/or recurrent symptoms, five sexually-active patients (9%) reported dyspareunia only; obstructed defecation symptoms recurred in ten women (19%); urinary incontinence occurred in eight patients (15%); four patients (11%) reported persistent perineal pain; and two patients (5%) experienced both the urge to defecate and voiding dysfunction. At the 10-year follow-up, 14/27 patients (52%) stated that they would undergo the same operation again, if necessary. Furthermore, the survey found that patients would recommend the combined surgery. CONCLUSION: The 10-year results of this study proved that combined rectal and urogynecological surgery is well tolerated, associated with low morbidity, and more effectively treats a distressing and debilitating condition vs separate surgeries for rectal and pelvic organ prolapse. We recommend complementing the relatively small scale of this study with randomized trials involving a sufficient number of patients, to provide more conclusive evidence on the cumulative long-term effects of combined surgery vs 2- or 3-stage surgery.

Effects of Extracorporeal Magnetic Stimulation in Fecal Incontinence.

Background: Fecal incontinence (FI) is a common condition that has devastating consequences for patients' QOL. In some patients, the conventional functional pelvic floor electrical stimulation has been effective but is an invasive and embarrassing treatment. The object of the study was to evaluate the feasibility of functional extracorporeal magnetic stimulation (FMS) in strengthening the pelvic floor muscles without an anal plug and the embarrassment of undressing. Materials and Methods: Thirty patients (26 female and 4 males) with FI were enrolled. All patients were assessed during a specialized coloproctology evaluation followed by endoanal ultrasonography and anorectal manometry. All patients underwent an FMS treatment once weekly for 8 weeks. Patients' outcome was assessed by the Cleveland Clinic Fecal Incontinence Score (CCFIS) and by the fecal incontinence QOL questionnaire (FIQL). Results: After 8 weeks, the number of solid and liquid stool leakage per week was significantly reduced (p<0.05) with a significant improvement of the CCFIS and of the FIQL (p<0.05). Moreover, the authors recorded a missed recruitment of the agonist and antagonists' defecation muscles. Conclusion: FMS is a safe, non-invasive and painless treatment for FI. It could be recommended for selected patients with non-surgical FI to ensure a rapid clinical improvement.

Middle-term Outcomes of Gatekeeper Implantation for Fecal Incontinence.

BACKGROUND: Intersphincteric injectable bulking agents are one of the current treatment options for fecal incontinence, failing behavioral and medical therapy. Gatekeeper showed promising short-term results, but long-term outcomes are unknown. OBJECTIVE: The purpose of this study was to clinically evaluate a prospective cohort of fecal incontinence patients up to 36 months after implantation of Gatekeeper. DESIGN: This was a prospective clinical study. SETTINGS: The study was conducted at a large university tertiary care hospital. PATIENTS: Consecutive female patients were eligible if fecal incontinence onset was ≥6 months before the first visit and symptoms were refractory to standard conservative measures. INTERVENTIONS: All of the patients underwent implantation of 4 or 6 Gatekeeper prostheses. Three-dimensional endoanal ultrasonography and high-resolution anorectal manometry were performed preoperatively and postoperatively at 2 and 3 months after implantation. MAIN OUTCOME MEASURES: The Cleveland Clinic Fecal Incontinence score was calculated at baseline and 1, 3, 12, 24, and 36 months postoperatively. RESULTS: Twenty patients (all women; median age, 59 y) were enrolled, and all implants were uneventful. Postoperative endoanal ultrasonography showed normal prosthesis localization in 16 patients (80%). At manometry, mean anal resting pressure significantly improved (57.8 ± 7.5 mm Hg; p = 0.0004). Mean preoperative Cleveland Clinic Fecal Incontinence score was 12.4 ± 1.8, with significant improvements initially documented at 3 months (4.9 ± 1.5; p < 0.0001) and sustained up to 36 months (4.9 ± 1.7; p < 0.0001). Patients receiving only 4 (compared with 6) prostheses and those experiencing pudendal neuropathy (compared with those who did not) showed significantly higher Cleveland Clinic Fecal Incontinence score values in the middle term. LIMITATIONS: The study was limited by its small sample size and absence of quality-of-life data. CONCLUSIONS: Initial improvements after Gatekeeper implantation for fecal incontinence are sustained in the middle term. Accurate preoperative evaluation of coexistent clinical conditions that may negatively affect outcomes is recommended for patient selection. See Video Abstract at http://links.lww.com/DCR/B109. RESULTADOS A MEDIANO PLAZO EN LA IMPLANTACIÓN DE GATEKEEPER PARA LA INCONTINENCIA FECAL: Los agentes de volumen inyectables interesfintéricos, son opciones actuales de tratamiento para la incontinencia fecal, ante fallas de terapias conductuales y médicas. Gatekeeper mostró resultados prometedores a corto plazo, pero resultados a largo plazo aún son desconocidos.Evaluar clínicamente una cohorte prospectiva de pacientes con incontinencia fecal, hasta 36 meses después de la implantación de Gatekeeper.Estudio clínico prospectivo.El estudio se realizó en un gran hospital universitario de atención terciaria.Fueron elegibles pacientes femeninas consecutivas, si el inicio de la incontinencia fecal, fue al menos 6 meses antes de la primera visita, y que los síntomas fueron refractarios a las medidas conservadoras estandarizadas.Todas las pacientes fueron sometidas a implantación de 4 o 6 prótesis Gatekeeper. Se realizó ecografía endoanal de 3D y manometría anorrectal de alta resolución, antes de la implantación y después a los 2 y 3 meses.Se calculó el puntaje de incontinencia fecal de la Cleveland Clinic al inicio, y a los 1, 3, 12, 24 y 36 meses después de la operación.Se inscribieron veinte pacientes (todas mujeres; con edad media de 59 años), y todos los implantes transcurrieron sin incidentes. La ecografía endoanal postoperatoria, mostró localización normal de la prótesis en 16 (80%) pacientes. A la manometría, la presión media de reposo anal, mejoró significativamente (57.8 ± 7.5 mmHg, p = 0.0004). La puntuación media preoperatoria de la incontinencia fecal de la Cleveland Clinic, fue de 12.35 ± 1.75, con mejoras significativas documentadas inicialmente a los 3 meses (4.9 ± 1.5, p <0.0001) y sostenidas hasta los 36 meses (4.9 ± 1.7, p <0.0001). Los pacientes que recibieron solo 4 prótesis (en comparación con 6) y que padecían neuropatía pudenda (en comparación con aquellas que no la padecían), mostraron valores de puntaje de Incontinencia Fecal de la Clínica Cleveland, significativamente más altos en el mediano plazo.El tamaño pequeño de la muestra y la ausencia de datos en calidad de vida.Las mejoras iniciales después de la implantación de Gatekeeper para la incontinencia fecal, se mantienen en el mediano plazo. Para la selección de pacientes, se recomienda una precisa evaluación preoperatoria de las condiciones clínicas coexistentes, que puedan afectar negativamente los resultados. Consulte Video Resumen en http://links.lww.com/DCR/B109.

Postoperative discomfort and pain in the management of hemorrhoidal disease: laser hemorrhoidoplasty, a minimal invasive treatment of symptomatic hemorrhoids.

Hemorrhoidal disease (HD) treatment still remains controversial. In fact, despite many surgical progresses, postoperative pain, and discomfort remain the major weaknesses. Laser hemorrhoidoplasty (LHP) is a minimal invasive procedure for HD treatment determining the shrinkage of the hemorrhoidal piles by diode laser. The aim of the current study is to analyze the feasibility and efficacy of LHP in patients with II-III degrees hemorrhoids. Consecutive patients with II-III degree hemorrhoids were enrolled in the study and underwent an LHP treatment using a 1470-nm diode laser. Operative time, postoperative pain and complications, resolution of symptoms, and length of return to daily activity were prospectively evaluated. Recurrence of prolapsed hemorrhoid or symptoms at a minimum follow-up of 6 months was evaluated. Fifty patients (28 males and 22 females) were enrolled in the study. No significant intraoperative complications occurred. Postoperative pain score (at 12, 18, and 24 h postoperatively), evaluated through visual analogue scale, was extremely low (mean value 2). No postoperative spontaneous bleeding occurred. The 100% of our population came back to daily activity 2 days after surgery. At a mean follow-up period of 8.6 months, we reported a recurrence rate of 0%. LHP demonstrated a large efficacy in selected patients. The greatest strength points were low postoperative pain, the presence of slightly significant peri-anal wounds, no special anal hygienic measures and low surgical time. Thus, resulting in a negligible postoperative discomfort, LHP could be considered a painless and minimal invasive technique in the treatment of HD.

Sacral nerve stimulation in slow-transit constipation: effectiveness at 5-year follow-up.

AIM: The aim of this study is to evaluate the short- and long-term efficacy of sacral nerve stimulation (SNS) for treating slow-transit constipation (STC). METHOD: This is a retrospective cohort analysis of the efficacy of SNS in treating patients affected by STC, who previously failed to respond to conservative therapies. Only patients free of concomitant diseases were enrolled in our study. A temporary stimulation lead was initially implanted; patients with a > 50% symptom reduction were eventually deemed eligible for a permanent implant. RESULTS: This study enrolled 25 patients who underwent a SNS test stimulation; 21 patients (13 women; median age 32 years) eventually got a permanent implant. The median preoperative Cleveland Clinic Constipation Score (CCCS) was 21 (16-25). Preoperative colorectal transit time recorded a median of 10 markers (7-19) retained in the colorectal tract. At 6-month postoperative follow-up, the total number of markers retained in the colorectal tract decreased to 3 (0-4). The CCCS score improved during the first postoperative year (P < 0.001), but progressively worsened over the longer term. The SF-36 questionnaire showed an improvement in all 8 scales measuring physical and psycho-emotional states; all parameters recorded into the bowel diary also improved. Overall, at 60-month follow up, the overall neuromodulator removal rate was 48%. CONCLUSIONS: The SNS is a minimally invasive surgical procedure that we tested for treating STC. The short-term outcome was promisingly after 6 months; however, there was a declining trend beyond this interval. Thus, the long-term efficacy of SNS needs to be further assessed.

D-shape asymmetric excision in recurrent pilonidalis disease: an analytic longitudinal long-term evaluation.

Sacrococcigeal pilonidalis disease (SPD) recurrence is a major factor influencing surgical outcomes. Several different surgical treatments have been reported, however, there is a lack of long-term data on reoperation. Aim of this study was to analyze outcomes of a single center adopting a standardized off-midline asymmetric procedure (D-shape). Analytic longitudinal assessment of 83 patients (median age 35 years, range 23-59 years) with recurrent SPD that completed the 5-year study design following D-shape reoperation. Among a cohort of 607 patients, we enrolled 83 recurrent SPD. After D-shape reoperation, second recurrence rate was 9.6% (8/83). Second recurrence rate was not statistically significantly different among patients undergone D-shape as first surgery compared to patients of symmetric excision group (11.8% vs. 7.4%, p = 0.57). Similarly, there was no statistical difference among patients who underwent D-shape as first surgery compared to patients who underwent symmetric excision elsewhere (11.8% vs. 9.1%, p = .75). D-shape is a safe and effective when adopted as revisional surgery at a long-term follow-up. Comparative evaluation is warranted to establish the potential superiority over different surgical surgery in case of recurrence.

A mini-invasive procedure for the treatment of supralevator abscess of cryptoglandular origin by extrasphincteric extension: preliminary results at 1-year follow-up.

AIM: The aim of this retrospective study is to evaluate the preliminary results of a mini-invasive procedure for the treatment of supralevator abscesses (SLA) of cryptoglandular origin by extrasphincteric extension. METHOD: In this clinical study, an innovative two-stage procedure was tested for the surgical treatment of SLA. As first step and as a preparation for surgery, the interventional radiologist positioned a CT-guided percutaneous perianal guidewire inside the abscess cavity under local anesthesia. As second step, the surgeon performed an abscess incision and drainage around the guidewire, with a complete debridement of all the necrotic tissue. If a complex anal fistula was identified, a loose seton was placed in situ. RESULTS: Nine patients, comprising 5 men (55%) and 4 women (45%), underwent the above-mentioned two-stage procedure to treat SLA of cryptoglandular origin. Median age was 32 years (range, 25-42 years). A silicone draining seton was placed during the surgical procedure in 5 patients (55%), since a coexisting fistula was also revealed by surgery. A repeat surgery, along with a new drainage procedure, was required in one patient out of nine (11.1%) for a complete wound healing. The complete wound healing was achieved after a median of 30 days (range, 26-38). At the 1-year follow-up, the healing rate was 89%. CONCLUSIONS: The treatment of SLA of cryptoglandular origin by using this innovative two-stage procedure may be a safe and convenient surgical option to effectively decrease the risk of recurrence and anal sphincteric injuries.

Permacol Collagen Paste Injection for Treatment of Complex Cryptoglandular Anal Fistulas: An Observational Cohort Study With a 2-Year Follow-up.

BACKGROUND: Permacol paste injection is a novel treatment approach for complex cryptoglandular anal fistulas. This study was performed to evaluate the long-term clinical outcomes of treatment with Permacol paste for complex cryptoglandular fistulas. METHODS: Patients with primary or recurrent complex cryptoglandular anal fistulas treated with Permacol paste from 2014 to 2016 were retrospectively analyzed. RESULTS: A total of 46 patients (median age, 41.3 years; 21 female) underwent Permacol paste injection; 20 patients (43%) had previously undergone failed fistula surgery. The patients had experienced anal fistula-related symptoms for a median of 10 weeks (range, 3-50 weeks). All patients had a draining seton in situ for a median of 10 weeks (range, 4-46 weeks). The median follow-up time was 24 months (range, 1-25 months). At the 1-month follow-up, 2 patients had paste extrusion and 2 had anal abscesses. The mean preoperative Continence Grading Scale score was 1.10 ± 1.40, and that at 3 months postoperatively was 1.13 ± 1.39 ( P = .322). There was a significant difference in the preoperative and the 1- and 3-month postoperative pain scores ( P < .001). At the 24-month follow-up, the healing rate was 50% (n = 23). A total of 19 patients (41%) with a recurrent fistula after failed Permacol paste injection required additional operative procedures. The satisfaction rate at the 2-year follow-up was 65%. CONCLUSION: Permacol paste injection is minimally invasive and technically easy to perform. It can be considered as a viable and reasonable option for the treatment of complex cryptoglandular anal fistulas in patients with fecal continence disorders.

Comparison of porcine collagen paste injection and rectal advancement flap for the treatment of complex cryptoglandular anal fistulas: a 2-year follow-up study.

BACKGROUND: Rectal advancement flap is the standard surgical treatment for complex cryptoglandular anal fistulas, while Permacol™ collagen paste is considered an innovative treatment option for anorectal fistulas. This study aimed to compare the clinical outcomes of patients with complex cryptoglandular fistulas treated by endorectal advancement flap versus Permacol™ paste. METHODS: This study was a retrospective analysis of patients with complex cryptoglandular anal fistulas. Thirty-one patients were treated with the rectal advancement flap (RAF group), while 21 were treated with Permacol™ paste injection (PP group). In PP group, the approach consisted of loose seton positioning followed several weeks later by closure internal opening with a resorbable sutures associated with paste injection into the fistula track. Clinical outcomes were assessed in terms of healing rate, faecal continence and patient satisfaction. RESULTS: Seton drainage was done in all patients in both groups for a median duration of 8 weeks (range 4-18 weeks) before the final surgery (p = 0.719). No patient had faecal incontinence (CGS ≥ 5) preoperatively. Five patients (16%) in the RAF group and one (5%) in the PP group experienced faecal incontinence postoperatively. The 2-year disease-free survival was 65% in the RAF group and 52% in the PP group (p = 0.659). The median satisfaction scores were 5 (range 1-10) in the RAF group and 7 (range 2-10) in the PP group (p = 0.299). CONCLUSION: The RAF appeared superior to PP in terms of fistula healing, although this result was not statistically significant. On the contrary, PP has a potential advantage in terms of continence disorders. Permacol™ paste can be considered as the initial treatment option for complex cryptoglandular anal fistulas in patients with faecal continence disorders.

Stapled Hemorrhoidopexy: Results at 10-Year Follow-up.

BACKGROUND: Despite the advantages of stapled hemorrhoidopexy reported in the literature in terms of postoperative pain, hospital stay, and duration of convalescence, it was described to have a higher recurrence rate compared with conventional hemorrhoidectomy. OBJECTIVE: The aim of this study was to evaluate clinical outcomes and patient satisfaction after stapled hemorrhoidopexy at 10-year follow-up. DESIGN: This was a retrospective cohort analysis conducted on prospectively collected data. SETTINGS: The study was conducted at a single tertiary care center. PATIENTS: Eighty-six consecutive patients treated with stapled hemorrhoidopexy for grade 3 hemorrhoidal prolapse between January and December 2006 were included. MAIN OUTCOME MEASURES: Patients satisfaction and recurrence rates were measured. RESULTS: Eighty-six patients (45 men and 41 women; median age, 49 y (range, 31-74 y)) underwent stapled hemorrhoidopexy. Eight patients had urinary retention during the immediate postoperative period, and 2 patients required a reoperation for suture line bleeding. The median hospital stay was 12 hours (range, 12-96 h). No suture line dehiscence, rectovaginal fistula, pelvic sepsis, anal abscess, or anal stenosis was recorded during the follow-up. Seventy-seven patients (90%) completed the expected follow-up, with a median duration of 119.0 months (range 115.4-121.8 mo). Among them, 30 patients (39%) experienced a recurrent hemorrhoidal prolapse, 8 of whom needed a reoperation. Thirty-four patients (44%) reported urge to defecate with a median visual analog scale of 1 (range, 1-7). Six patients (8%) reported gas leakage at the last follow-up visit, whereas no liquid or solid stool leakage was recorded. Satisfaction rate at 10-year follow-up was 68%. LIMITATIONS: The study was limited by its small sample size and lack of a control group. CONCLUSIONS: The high recurrence rate and low patient satisfaction rate showed that stapled hemorrhoidopexy reduces its efficacy in the long-term. See Video Abstract at http://links.lww.com/DCR/A510.

A new technique for tension-free reconstruction in large incisional hernia.

In the surgical management of large incisional hernias, the main target is the closure of the abdominal wall defect on the midline without a dangerous increase in the intraabdominal pressure. In this setting, new intraperitoneal prosthesis and components separation techniques were proposed to solve this problem. Both solutions present some critical issues. A new surgical approach with a free lateral double layer prosthesis totally in polypropylene both sides (FLaPp®) is proposed to overcome this problem. This is a retrospective cohort analysis study with a prospectively collected database from two different Italian hospitals. Twenty-nine patients operated from April 2010 to December 2015 were treated using the new prosthesis. Four patients developed postoperative complications: one (3.4%) presented wound infection, two (6.9%) experienced seroma, and one had a hematoma (3.4%). No deaths were recorded. At a median follow-up of 28.5 months (IQR 22-36), no hernia relapse occurred. The application of FLaPp® mesh is a safe and feasible option that can be employed to manage Rives repair in cases of abdominal wall defects with difficult closure of the posterior plan when the conventional prosthetic meshes could be unsuitable.

Effect of a mixture of diosmin, coumarin glycosides, and triterpenes on bleeding, thrombosis, and pain after stapled anopexy: a prospective, randomized, placebo-controlled clinical trial.

PURPOSE: We evaluated the efficacy of oral administration of a mixture of diosmin, coumarin glycosides, and Centella asiatica (Venoplant®) in preventing bleeding, pain, and thrombosis of internal and external hemorrhoids after stapled anopexy (SA). METHODS: SA was conducted in 182 patients with third-degree hemorrhoids. Preoperatively, patients were randomized evenly into two groups. Group A patients were administered Venoplant for 30 days post-SA, and group B received a placebo for 30 days post-SA. Patients received paracetamol for postoperative pain. Visit (v)1, v2, and v3 took place 7, 15, and 30 days postoperatively, respectively; bleeding (clinical examination), visual analog scale (VAS), thrombosis (clinical examination), and pain (paracetamol dosage, VAS) were evaluated. RESULTS: At v1, v2, and v3, the numbers of patients with bleeding in groups A and B were 21 and 46, 3 and 25, and 1 and 5, respectively (p < 0.05). At v1, v2, and v3, the numbers of patients in groups A and B with thrombosed internal hemorrhoids were 3 and 13, 2 and 11, and 1 and 8, respectively (p < 0.05). The number of patients who took at least one paracetamol tablet was similar in both groups at v1 but was significantly greater in group B than group A at v2 and v3 (p < 0.05); pain VAS scores were equivalent at v1 and significantly greater in group B than group A at v2 and v3 (p < 0.05). CONCLUSIONS: Venoplant effectively reduced bleeding after SA, decreased the incidence of thrombosed internal hemorrhoids, and decreased postoperative pain.

Tailored prolapse surgery for the treatment of haemorrhoids and obstructed defecation syndrome with a new dedicated device: TST STARR Plus.

OBJECTIVE: The aim of the study was to assess the safety, efficacy and feasibility of stapled transanal procedures performed by a new dedicated device, TST STARR Plus, for tailored transanal stapled surgery. METHODS: All the consecutive patients admitted to eight referral centres affected by prolapses with III-IV degrees haemorrhoids or obstructed defecation syndrome (ODS) with rectocele and/or rectal intussusception that underwent stapled transanal resection with TST STARR plus were included in the present study. Haemostatic stitches for bleeding of the suture line, specimen volume, operative time, hospital stay and perioperative complications were recorded. RESULTS: From 1 November 2012 to 31 March 2013, 160 consecutive patients (96 females) were enrolled in the study. In 94 patients, the prolapse was over the half of the circular anal dilator (CAD). The mean duration of the procedure was 25 min. The mean resected volume of the specimen was 13.3 cm(3), the mean hospital stay was 2.2 days. In 88 patients (55%), additional stitches on the suture line were needed (mean 2.1). Suture line dehiscence was reported in four cases, with intraoperative reinforcement. Bleeding was reported in seven patients (5%). Urgency after 30 days was reported in one patient. No major complication occurred. CONCLUSIONS: The new device seems to be safe and effective for a tailored approach to anorectal prolapse due to haemorrhoids or obstructed defecation.

Italian Biological Prosthesis Work-Group (IBPWG): proposal for a decisional model in using biological prosthesis.

INTRODUCTION: Indications for repair of abdominal hernia are well established and widely diffused. Controversies still exist about the indication in using the different prosthetic materials and principally about the biological ones. MATERIAL AND METHODS: In February 2012, the Italian Biological Prosthesis Work-Group (IBPWG), counting a background of 264 biologic implants, met in Bergamo (Italy) for 1-day meeting with the aim to elaborate a decisional model on biological prosthesis use in abdominal surgery. RESULTS: A diagram to simplify the decisional process in using biologics has been elaborated. CONCLUSION: The present score represents a first attempt to combine scientific knowledge and clinical expertise in order to offer precise indications about the kind of biological mesh to use.

Glyceryl trinitrate ointment (0.25%) and anal cryothermal dilators in the treatment of chronic anal fissures.

INTRODUCTION: Chronic anal fissure is a common benign disorder; for this condition, lateral internal sphincterotomy is the "gold standard" of treatment. Alternative medical treatments have not proven to be as effective as left lateral internal sphincterotomy. AIM: This randomized trial was designed to compare the use of 0.25% glyceryl trinitrate ointment and anal cryothermal dilators with the use of 0.4% glyceryl trinitrate ointment alone in the treatment of chronic anal fissures. METHODS: Between 1 June 2006 and 31 December 2007, 60 consecutive patients who were suffering from chronic anal fissures were randomized into two groups. The patients in group A (n = 30) were treated with 0.25% glyceryl trinitrate ointment and anal cryothermal dilators twice daily, and those in group B (n = 30) were treated with 0.4% glyceryl trinitrate ointment alone twice daily. The treatment was administered to the patients in each group for 6 weeks, and all patients were examined 7 weeks after the start of the trial. RESULTS: Prior to treatment, the symptoms and the measurements of anal pressure were similar in both groups. At 7 weeks, the maximum resting pressure was significantly lower in group A (P < 0.05), in which 86.6% of the patients were asymptomatic in comparison with 73.3% of the patients in group B. After 1 year of follow-up, 25 patients (83.3%) in group A and 18 patients (60%) in group B presented no recurrence of symptoms (P < 0.05) CONCLUSIONS: Treatment of chronic anal fissures with 0.25% glyceryl trinitrate ointment and anal cryothermal dilators was more effective than the administration of 0.4% glyceryl trinitrate ointment alone.

Cost-revenue analysis in the surgical treatment of the obstructed defecation syndrome.

The obstructed defecation syndrome is a frequent condition in the female population. Rectocele and rectal intussusception may cause symptoms of obstructed defecation. The aim of this study is to carry out an economic cost-revenue analysis comparing the rectocele and the rectal intussusception surgical techniques using a double-transanal, circular stapler (Stapled Trans-Anal Rectal Resection - STARR) with other techniques used to repair the same defects. The analysis involved the systematic calculation of the costs incurred during hospitalisation. The revenue estimate was obtained according to the rate quantification of the Diagnosis Related Group (DRG) associated with each hospitalisation. Our analysis confirmed that the global expenditure for the STARR technique amounts to 3,579.09 Euro as against 5,401.15 Euro for rectocele abdominal repair and 3,469.32 Euro for perineal repair. The intussusception repair cost according to Delorme's procedure amounts to 5,877.41Euro as against 3,579.09 Euro for the STARR technique. The revenue analysis revealed a substantial gain for the Health Authority as regards the treatment of rectocele and rectal intussusception for obstructed defecation syndrome. The highest revenue, 6,168. 52 Euro, was obtained with intussusception repair with STARR as compared to Delorme's procedure which presented revenue amounting to 2,359.04. Lower revenues are recorded if the STARR technique is intended for rectocele repair; in this case the revenue amounts to 1,778.12 Euro as against 869.67 Euro and 1,887.89 Euro for abdominal and perineal repair, respectively.

Randomized, prospective trial comparing 0.25 percent glycerin trinitrate ointment and anal cryothermal dilators only with 0.25 percent glycerin trinitrate ointment and only with anal cryothermal dilators in the treatment of chronic anal fissure: a two-year follow-up.

PURPOSE: The objective of this study was to compare the efficacy of 0.25 percent glycerin trinitrate ointment in association with cryothermal anal dilators with 0.25 percent glycerin trinitrate ointment only and cryothermal anal dilators only. METHODS: A total of 48 patients suffering from chronic anal fissure were enrolled in this prospective, randomized study between January 2002 and December 2003: Group A, 16 patients were treated with 0.25 percent glycerin trinitrate ointment and also used cryothermal anal dilators; Group B, 16 patients were treated with 0.25 percent glycerin trinitrate ointment only; Group C, 16 patients were treated with cryothermal anal dilator use only. All patients in each group followed the specified treatment protocol for six weeks. RESULTS: After seven weeks of treatment, the symptoms complained of were resolved in 15 patients (93.7 percent) in Group A, 12 patients (75 percent) in Group B, and 12 patients (78 percent) in Group C. After two years of follow-up, 14 patients (87.5 percent) in Group A, 9 patients (56.2 percent) in Group B, and 10 patients (62.5 percent) in Group C presented no recurrence of symptoms. No patient in any group reported serious side effects of the treatment proposed, and treatment did not have to be withdrawn in any of the randomized patients. No episodes of anal incontinence of gas or feces were recorded in the patients who had used the anal dilators. CONCLUSIONS: The combined treatment for chronic anal fissure proved to be efficacious, safe, and with statistically significant better results than the other treatments analyzed.