Intraoperative Sono-assessment In Deep Endometriosis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age20-60
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Previous major bowel surgery or primary indication for bowel resection

Inflammatory bowel disease, malignancy, or severe pelvic pathology

Inability to complete study questionnaires

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed

Locations

This trial has no locations