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.
Female patients aged 20-60 years
Rectal or sigmoid nodule with muscularis propria infiltration ≥1 mm and <20 mm (assessed by expert transvaginal ultrasound)
Indication for surgery agreed upon with the patient
Written informed consent
Previous major bowel surgery or primary indication for bowel resection
Inflammatory bowel disease, malignancy, or severe pelvic pathology
Inability to complete study questionnaires
The study population consists of women of reproductive age diagnosed with deep infiltrating endometriosis involving the rectum or sigmoid colon, with muscularis propria infiltration between 1 and 20 mm as assessed by expert preoperative transvaginal ultrasound. Eligible patients are those scheduled to undergo laparoscopic rectal shaving as part of standard clinical care at a tertiary referral center for endometriosis. All participants provide written informed consent prior to enrollment.
Cohort
Prospective
Not listed
Change in Gastrointestinal Symptoms and Quality of Life Scores
Change in gastrointestinal symptom severity and quality of life (PAC-SYM and PAC-QOL scores) from baseline to 12 months, stratified by depth of muscular infiltration (1-6 mm, 7-12 mm, 13-20 mm)
Association Between Residual Bowel Wall Thickness and Surgical Complications
Evaluation of the relationship between intraoperatively measured minimum residual bowel wall thickness at the site of rectal shaving and the occurrence of postoperative complications, including bowel perforation, rectovaginal fistula, anastomotic stenosis, and other complications.
Identification of Predictive Ultrasound Cut-off Values
Identification of predictive cut-off values for intraoperative ultrasound parameters (e.g., residual nodule thickness, depth of infiltration, and bowel wall thickness) associated with postoperative outcomes and surgical complexity.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
