Intraoperative Sono-assessment In Deep Endometriosis
Starting soon
Conditions studied: Endometriosis, Endometriosis-related Pain, Pelvic Pain Syndrome, Endometriosis, Rectum, Endometriosis of Colon
In brief
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.
Key facts
- Study ID
- NCT07517081
- Run by
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- People needed
- 57
- Starts
- 2026-04-07
- Expected to finish
- 2028-07-07
- Last updated by the study team
- 2026-04-08
Who can join
Age: 20 and older, up to 60. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Previous major bowel surgery or primary indication for bowel resection
- Inflammatory bowel disease, malignancy, or severe pelvic pathology
- Inability to complete study questionnaires
Full record on ClinicalTrials.gov
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