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NCT07517055Not yet recruiting

Intraoperative vs Transvaginal Ultrasound in Rectosigmoid Endometriosis

Comparative Study of Transvaginal and Intraoperative Ultrasound in Rectosigmoid Deep Infiltrating Endometriosis

Source: ClinicalTrials.gov · Last updated 8 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
98 (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
NCT number
NCT07517055

What you commit to

  • Study type: Observational
  • Planned participants: 98
  • 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 bowel resection for deep infiltrating endometriosis

Other illness

  • Active inflammatory bowel disease

Other

  • Pregnancy
  • Technical inability to perform transvaginal or intraoperative ultrasound
  • Refusal or withdrawal of informed consent

Who the study is looking for

  • 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

Age in the registry: 18 years to 55 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.