Clinical Trial

Intraoperative Sono-assessment In Deep Endometriosis

Study acronym: INSIDE
Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
Deep infiltrating endometriosis (DIE) involving the bowel, particularly the rectosigmoid region, is associated with significant gastrointestinal symptoms and impaired quality of life. Rectal shaving is a conservative surgical technique aimed at removing endometriotic lesions while preserving bowel integrity; however, it may result in residual disease or excessive thinning of the bowel wall, potentially leading to recurrence or complications. Intraoperative ultrasound (IOUS) allows real-time assessment of residual nodule thickness and bowel wall thickness after shaving. This prospective observational study aims to evaluate the relationship between intraoperative ultrasound measurements and postoperative clinical outcomes, including gastrointestinal symptoms and quality of life. The study also seeks to identify ultrasound cut-off values that may guide intraoperative surgical decision-making and optimize the balance between radicality and safety.
Trial Details
NCT Number NCT07517081
Lead Sponsor Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions Endometriosis, Endometriosis-related Pain, Pelvic Pain Syndrome, Endometriosis, Rectum, Endometriosis of Colon
Enrollment 57 participants
Start Date 2026-04-07
Primary Completion 2027-04-07 (estimated)
Study Completion 2028-07-07 (estimated)
Updated on ClinicalTrials.gov 2026-04-08