Intraoperative Sono-assessment In Deep Endometriosis

NCT07517081 | Not Yet Recruiting

• 1 other identifier: 27052
• Study Type: observational
• Target: 57
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Endometriosis-related Pain; Pelvic Pain Syndrome; Endometriosis, Rectum; Endometriosis of Colon; Endometriosis

Outcome Measures

Primary Outcomes (1)

• 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)

  12 months

Secondary Outcomes (2)

• Association Between Residual Bowel Wall Thickness and Surgical Complications

  12 months

• Identification of Predictive Ultrasound Cut-off Values

  12 months

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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.

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Giorgia Gaia

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giorgia Gaia

CONTACT

+393384406299; giorgia.gaia@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 8, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): April 7, 2027
• Study Completion (Estimated): July 7, 2028
• Last Updated: April 8, 2026

Record last verified: 2026-03