Prevention of parastomal hernia with a preperitoneal polypropelene mesh.

OBJECTIVE: To show our results with the use of a polypropylene mesh at the stoma site, as prophylaxis of parastomal hernias in patients with rectal cancer when a terminal colostomy is performed. METHODS: From January 2010 until March 2014, 45 consecutive patients with rectal cancer, underwent surgical treatment with the need of a terminal colostomy. A prophylactic mesh was placed in a sublay position at the stoma site in all cases. We analyze Demographics, technical issues and effectiveness of the procedure, as well as subsequent complications. RESULTS: A prophylactic mesh was placed in 45 patients, 35 male and 10 females, mean age of 66.2 (47-88) and Body Mass Index 29.19 (20.4-40.6). A total of 7 middle rectal carcinoma, 36 low rectal carcinoma, one rectal melanoma and one squamous cell anal carcinoma were electively treated with identical protocol. Abdominoperineal resection was performed in 38 patients, and low anterior resection with terminal colostomy in 7. An open approach was elected in 39 patients and laparoscopy in 6, with 2 conversions to open surgery. Medium follow up was 22 months (2.1-53). Overall, 3 parastomal hernias (6.66%) were found, one of which was a radiological finding with no clinical significance. No complications related to the mesh or the colostomy were found. CONCLUSIONS: The use of a prophylactic polypropylene mesh placed in a sublay position at the stoma site is a safe and feasible technique. It lowers the incidence of parastomal hernias with no increased morbidity.

Endoscopic treatment (endoscopic balloon dilation/self-expandable metal stent) vs surgical resection for the treatment of de novo stenosis in Crohn's disease (ENDOCIR study): an open-label, multicentre, randomized trial.

BACKGROUND: Stenosis is one of the most common complications in patients with Crohn's disease (CD). Endoscopic balloon dilation (EBD) is the treatment of choice for a short stenosis adjacent to the anastomosis from previous surgery. Self-expandable metal stents (SEMS) may be a suitable treatment option for longer stenoses. To date, however, there is no scientific evidence as to whether endoscopic (EBD/SEMS) or surgical treatment is the best approach for de novo or primary stenoses that are less than 10 cm in length. METHODS/DESIGN: Exploratory study as "proof-of-concept", multicentre, open-label, randomized trial of the treatment of de novo stenosis in the CD; endoscopic treatment (EBD/SEMS) vs surgical resection (SR). The type of endoscopic treatment will initially be with EDB; if a therapeutic failure occurs, then a SEMS will be placed. We estimate 2 years of recruitment and 1 year of follow-up for the assessment of quality of life, costs, complications, and clinical recurrence. After the end of the study, patients will be followed up for 3 years to re-evaluate the variables over the long term. Forty patients with de novo stenosis in CD will be recruited from 15 hospitals in Spain and will be randomly assigned to the endoscopic or surgical treatment groups. The primary aim will be the evaluation of the patient quality of life at 1 year follow-up (% of patients with an increase of 30 points in the 32-item Inflammatory Bowel Disease Questionnaire (IBDQ-32). The secondary aim will be evaluation of the clinical recurrence rate, complications, and costs of both treatments at 1-year follow-up. DISCUSSION: The ENDOCIR trial has been designed to determine whether an endoscopic or surgical approach is therapeutically superior in the treatment of de novo stenosis in CD. TRIAL REGISTRATION: ClinicalTrials.gov NCT04330846. Registered on 1 April 1 2020. https://clinicaltrials.gov/ct2/home.