Evaluation of a new synthetic plug in the treatment of anal fistulas: results of a pilot study.

BACKGROUND: The treatment of anal fistulas using plugs is a very promising method because of its simplicity and ability to be carried out on an ambulatory basis. If unsuccessful, it does not compromise subsequent alternative surgical techniques and/or products. However, success rates are variable. OBJECTIVE: This pilot study was designed to investigate the safety and effectiveness of a new synthetic plug in the treatment of transsphincteric anal fistulas. DESIGN: This was a prospective observational study. SETTING: Patients were treated at 2 colorectal surgery centers in Spain (Seville and Huelva). INTERVENTIONS: Anal fistulas were treated with a fistula plug made of bioabsorbable polymers (67% polyglycolide, 33% trimethylene carbonate). PATIENTS: Starting in January 2009, consecutive adult patients with transsphincteric anal fistulas were evaluated. MAIN OUTCOME MEASURES: Outcome measures included rates of successful fistula closure, complications, and continence (Jorge-Wexner incontinence score), assessed postoperatively at 1 week and again at 1, 3, 6, and 12 months. Healing was determined by clinical examination by a surgeon blinded for the intervention. RESULTS: A total of 19 patients (18 men, 1 woman) with transsphincteric anal fistulas were included in the study. The median age was 49 (range, 33-65) years. Of these patients, 12 presented with fistula relapse. The median time from onset of symptoms to surgery was 12 (range, 6-120) months. Three patients had previously placed setons. The follow-up duration was 12 months. Relapse occurred in 16 patients (with a perianal abscess in 1), and successful closure was observed in 3 patients (15.8%). LIMITATIONS: The number of patients was small, and time was needed for the learning curve of the technique. CONCLUSIONS: This study indicates that the new synthetic plug is safe, but the fistula closure rate was low. Randomized studies are needed to further determine the role of the bioabsorbable synthetic plug in the management of anal fistulas.

Evaluation of the use of posterior tibial nerve stimulation for the treatment of fecal incontinence: preliminary results of a prospective study.

PURPOSE: Neuromodulation therapies have been used with success in patients with fecal incontinence. Intermittent percutaneous tibial nerve stimulation is a new, minimally invasive treatment option for these patients. This study was designed to evaluate the results of intermittent percutaneous tibial nerve stimulation in patients with fecal incontinence. METHODS: Sixteen patients (11 females; mean age, 59 +/- 7.9 years) with severe fecal incontinence were treated with percutaneous tibial nerve stimulation. All patients completed a defecation diary, the Wexner Fecal Continence Scale, a fecal incontinence quality-of-life questionnaire, and a visual analog scale before treatment and during each phase of the study. Endoluminal ultrasound and anorectal physiologic studies were also performed in each patient. RESULTS: Continence was improved in 10 of 16 patients after the first phase. Six patients did not continue to the second phase of treatment because of a lack of initial response. During the second phase, 7 of 16 continued to show improvement. After a six-month period without any treatment, 5 of 16 continued to have good continence. Overall, percutaneous tibial nerve stimulation significantly improved fecal continence. The Wexner score improved from a mean of 13.2 +/- 4.1 at baseline to 9 +/- 5.2 at the end of the first phase (P < 0.0005), to 8 +/- 5.7 at the end of the second phase (P = 0.001), and to 9.1 +/- 5 after 6 months without treatment (P = 0.001). Significant improvement was observed in three main domains of the fecal incontinence quality-of-life scale: coping/behavior, depression, and embarrassment. Scores on the visual analog scale improved from a mean of 4.6 +/- 1.5 at baseline to 7 +/- 2.5 at the end of the first phase (P = 0.002) and to 7.2 +/- 2.5 after 6 months without treatment (P = 0.001). CONCLUSION: Percutaneous tibial nerve stimulation is a minimally invasive and effective treatment option for patients with fecal incontinence.

Possible role of chondroitin sulphate and glucosamine for primary prevention of colorectal cancer. Results from the MCC-Spain study.

A safe and effective colorectal cancer (CRC) chemoprevention agent remains to be discovered. We aim to evaluate the association between the use of glucosamine and/or chondroitin sulphate and risk of colorectal cancer (CRC) in the MCC-Spain study, a case-control study performed in Spain that included 2140 cases of CRC and 3950 population controls. Subjects were interviewed on sociodemographic factors, lifestyle, family and medical history and regular drug use. Adjusted odds ratios and their 95% confidence intervals were estimated. The reported frequency of chondroitin and/or glucosamine use was 2.03% in controls and 0.89% in cases. Users had a reduced risk of CRC (OR: 0.47; 95% CI: 0.28-0.79), but it was no longer significant when adjusted for NSAID (nonsteroidal anti-inflammatory drugs) use (OR: 0.82; 95% CI: 0.47-1.40). A meta-analysis with previous studies suggested a protective effect, overall and stratified by NSAID use (OR: 0.77; 95% CI: 0.62-0.97). We have not found strong evidence of an independent preventive effect of CG on CRC in our population because the observed effects of our study could be attributed to NSAIDs concurrent use. These results merit further research due to the safety profile of these drugs.

[Randomised study of the use resorbable mesh for the prevention of evisceration in colorectal surgery]. / Estudio aleatorizado sobre la utilización de mallas reabsorbibles para la prevención de la evisceración en la cirugía colorrectal.

INTRODUCTION: Evisceration is a complication that causes high morbidity and mortality, and its incidence in colorectal surgery varies between 2% and 3.5%. We evaluated the results of the use of resorbable meshes in the primary closure of laparotomies, with the purpose of preventing evisceration in colorectal surgery. PATIENTS AND METHOD: One hundred and forty three patients were included (63 females/80 males) and divided in two groups: simple closed laparotomy (Group A) (72 patients) and closed with polyglycolic mesh (Group B) (73 patients), mean age 64 years (range 24-93). We evaluated: general and previous clinical data, as well as evisceration, infection, seroma and other acute complications after the surgery. RESULTS: There were no differences between group distribution by general performances, associated pathology, clinical state and primary diagnosis. Most of Group B had programmed surgery (p = 0.045); mesh was used in 4 of 5 patients with faecal peritonitis, as expected drainage requirements were significant in Group B was needed significantly needed use drainages (Group A, 2.8%; Group B, 97.2%; p < 0.0005) and subsequent FNA after their withdrawal (p < 0.05). Overall incidence of evisceration was 3.5%, with Group A 5.6% and Group B 1.4%, with no significant differences. There were no differences in wounded infection. CONCLUSIONS: This study has not been able to demonstrate that primary closure with mesh in these patients prevents evisceration, due to small sample size, and having a high incidence of seromas. Until further studies are carried out, its use should be reserved for selected cases, as it can be used in the presence of pus or faeces.

Evaluation of the use of BioGlue in the treatment of high anal fistulas: preliminary results of a pilot study.

PURPOSE: Treatment of anal fistulas by use of adhesives is an attractive method because of its simplicity and it can be performed on an ambulatory basis. Furthermore, if the treatment is unsuccessful, adhesive use does not subsequently prevent the surgeon from utilizing alternative surgical techniques and/or products. BioGlue Surgical Adhesive is a two-component surgical adhesive composed of bovine serum albumin and glutaraldehyde. We evaluated the usefulness of BioGlue for the treatment of high transsphincter anal fistulas. METHODS: Patients diagnosed with high transsphincter anal fistulas of cryptoglandular origin, whether relapsed or not, were included in this study. A seton was placed before the injection of BioGlue into the fistula track of high transsphincter anal fistulas in patients with secondary tracts and/or purulent collections. Clinical charts, operative reports, and endoanal echography results obtained for each patient were reviewed. RESULTS: Fourteen patients (13 males; mean age, 39.9 (range, 24-66) years) with high transsphincter anal fistulas of cryptoglandular origin were recruited into the study. The average time of symptom evolution was 35.6 (range, 2-96) months. Ten of 14 cases were for relapsed fistulas. Six patients required the placement of a seton 37 (range, 32-42) days before the BioGlue injection. Patients were followed for a mean length of 13.92 (range, 3-21) months, and the fistula healed completely in only seven patients (50 percent). CONCLUSIONS: These preliminary results demonstrate that BioGlue may be useful for treating patients with high transsphincter anal fistulas. Further prospective long-term studies are needed.