Intraoperative vs Transvaginal Ultrasound in Rectosigmoid Endometriosis

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-55
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Previous bowel resection for deep infiltrating endometriosis

Active inflammatory bowel disease

Pregnancy

Technical inability to perform transvaginal or intraoperative ultrasound

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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).

Time frame
12 months

Secondary outcomes

1

Measurement Difference Between TVUS and IO-US

Mean and absolute differences between lesion measurements obtained by TVUS and IO-US (craniocaudal diameter, laterolateral diameter, depth of infiltration, and percentage of bowel circumference involvement).

Time frame
12 months
2

Agreement Analysis Between TVUS and IO-US

Assessment of agreement between TVUS and IO-US measurements using Bland-Altman plots, including bias and limits of agreement.

Time frame
12 months
3

Intraobserver and Interobserver Reproducibility

Assessment of reproducibility of ultrasound measurements using intraclass correlation coefficient (ICC) for intra- and interobserver variability.

Time frame
12 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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