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.

Navigating surgical anatomy of the Denonvilliers' fascia and dissection planes of the anterior mesorectum with a cadaveric simulation model.

Anterior dissection of the rectum in the male pelvis represents one of the most complex phases of total meso-rectal excision. However, the possible existence of different anatomical planes is controversial and the exact anatomical topography of Denonvilliers' fascia is still debated. The aim of the study is to accurately define in a cadaveric simulation model the existence and boundaries of Denonvilliers' fascia, identifying the anatomical planes suitable for surgical dissection. The pelvises of 31 formalin-preserved male cadavers were dissected. Careful and detailed dissection was carried out to visualize the anatomical structures and the potential dissection planes, simulating an anterior meso-rectum dissection. Denonvilliers' fascia was identified in 100% of the pelvises, as a single-layer fascia that originates from the peritoneal reflection and descends until its firm adhesion to the prostate capsule. The fascia divides the space providing an anterior and a posterior plane. Anteriorly to the fascia, during the caudal dissection, its firm adhesion to the prostate capsule forces to section it sharply. The cadaveric simulation model allowed an accurate description of Denonvilliers' fascia, defining several planes for anterior dissection of the meso-rectum.