Intraoperative Sono-assessment In Deep Endometriosis

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.

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Key information

Conditions

Endometriosis Endometriosis of Colon Endometriosis, Rectum Endometriosis-related Pain Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Pelvic Pain Syndrome Urogenital Diseases

Age range

20 year–60 year

Sex eligibility

Female

Study type

Observational

About this study

Endometriosis affects approximately 7-10% of women of reproductive age and is frequently associated with delayed diagnosis. Deep infiltrating endometriosis involving the posterior compartment often causes gastrointestinal symptoms such as dyschezia, constipation, diarrhea, and rectal bleeding.

Surgical management of bowel DIE includes conservative approaches (rectal shaving) and radical procedures (disc excision or segmental resection). Current guidelines emphasize individualized treatment decisions.

Rectal shaving avoids bowel resection and is associated with lower morbidity but carries risks of residual disease and bowel wall thinning. Intraoperative ultrasound enables precise measurement of residual lesions and bowel wall thickness, potentially improving surgical outcomes.

This study evaluates whether:

Greater residual nodule thickness is associated with persistent or recurrent symptoms;
Reduced bowel wall thickness is associated with increased postoperative complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Previous major bowel surgery or primary indication for bowel resection
Inflammatory bowel disease, malignancy, or severe pelvic pathology
Inability to complete study questionnaires

Treatment and study plan

Primary outcomes

Change in Gastrointestinal Symptoms and Quality of Life Scores

Time frame: 12 months

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)

Secondary outcomes

Association Between Residual Bowel Wall Thickness and Surgical Complications

Time frame: 12 months

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

Time frame: 12 months

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Giorgia Gaia

CONTACT

[email protected]

+393384406299

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

Intraoperative Ultrasound in Rectal Shaving for Deep Infiltrating Endometriosis: Evaluation of Residual Disease, Bowel Wall Thickness, and Clinical Outcomes

Acronym: INSIDE

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2028
First posted: Apr 8, 2026
Registry last updated: Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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