Intraoperative vs Transvaginal Ultrasound in Rectosigmoid Endometriosis

NCT07517055 | Not Yet Recruiting

• 1 other identifier: 27029
• Study Type: observational
• Target: 98
• Locations: 0 countries
• Sites: N/A

Brief Summary

Deep infiltrating endometriosis (DIE) of the rectum and rectosigmoid colon represents one of the most severe forms of endometriosis and often requires surgical management when symptomatic and unresponsive to medical therapy. Accurate preoperative assessment of lesion size, extent, and depth of bowel infiltration is essential to guide surgical planning and minimize complications. Transvaginal ultrasound (TVUS) is the first-line imaging technique for the diagnosis of pelvic endometriosis and has high diagnostic accuracy for detecting rectosigmoid lesions. However, its ability to precisely assess infiltration depth and guide the choice of surgical technique may be limited by anatomical distortion and technical factors. Intraoperative ultrasound (IO-US) is a real-time imaging modality that can be performed during laparoscopic surgery after adhesiolysis, allowing direct evaluation of bowel lesions. It may improve the assessment of lesion characteristics and support intraoperative decision-making, potentially reducing unnecessary bowel resections. This prospective single-center comparative study aims to evaluate the agreement between preoperative TVUS and intraoperative ultrasound in measuring rectal and rectosigmoid DIE nodules. Secondary objectives include assessing measurement differences, identifying factors associated with discordance, and evaluating the reproducibility of ultrasound measurements. The findings of this study may improve preoperative counseling, optimize surgical planning, and support the integration of intraoperative ultrasound into the management of bowel endometriosis.

Conditions

Endometriosis; Endometriosis of Colon; Endometriosis; Bowel; Endometriosis, Rectum

Outcome Measures

Primary Outcomes (1)

• Agreement Between TVUS and IO-US Measurements

  Agreement between preoperative transvaginal ultrasound (TVUS) and intraoperative ultrasound (IO-US) in measuring rectal and rectosigmoid deep infiltrating endometriosis nodules, assessed using the intraclass correlation coefficient (ICC).

  12 months

Secondary Outcomes (3)

• Measurement Difference Between TVUS and IO-US

  12 months

• Agreement Analysis Between TVUS and IO-US

  12 months

• Intraobserver and Interobserver Reproducibility

  12 months

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with suspected deep infiltrating endometriosis of the posterior compartment involving the rectum or rectosigmoid colon who are scheduled for surgical treatment.

You may qualify if:

• Women aged 18 to 55 years
• Clinical and/or imaging suspicion of rectal or rectosigmoid deep infiltrating endometriosis (DIE)
• Indication for laparoscopic or robotic surgery for DIE
• Ability and willingness to provide written informed consent

You may not qualify if:

• Previous bowel resection for deep infiltrating endometriosis
• Active inflammatory bowel disease
• Pregnancy
• Technical inability to perform transvaginal or intraoperative ultrasound
• Refusal or withdrawal of informed consent

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