NCT07517081Not yet recruiting
Intraoperative Sono-assessment In Deep Endometriosis
Intraoperative Ultrasound in Rectal Shaving for Deep Infiltrating Endometriosis: Evaluation of Residual Disease, Bowel Wall Thickness, and Clinical Outcomes
Source: ClinicalTrials.gov · Last updated 8 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 57 (estimated)
- First submitted
- 1 Apr 2026
- Start date
- 7 Apr 2026
- Primary completion date
- 7 Apr 2027
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Endometriosis
- NCT number
- NCT07517081
What you commit to
- Study type: Observational
- Planned participants: 57
- From 7 Apr 2026 to the primary completion date, 7 Apr 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous major bowel surgery or primary indication for bowel resection
Other illness
- Inflammatory bowel disease, malignancy, or severe pelvic pathology
Other
- Inability to complete study questionnaires
Who the study is looking for
- 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
Age in the registry: 20 years to 60 years · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.