NCT07517055|Not Yet Recruiting
Intraoperative vs Transvaginal Ultrasound in Rectosigmoid Endometriosis
INTREND
Comparative Study of Transvaginal and Intraoperative Ultrasound in Rectosigmoid Deep Infiltrating Endometriosis
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INTREND
Comparative Study of Transvaginal and Intraoperative Ultrasound in Rectosigmoid Deep Infiltrating Endometriosis
Sponsor study identifier
observational
98
0 countries
N/A
Study Start
April 7, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 7, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 7, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 7, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 1, 2026
Actual (reported)April 7, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 8, 2026
Actual (reported)April 7, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 7, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Measurement Difference Between TVUS and IO-US
12 months
Agreement Analysis Between TVUS and IO-US
12 months
Intraobserver and Interobserver Reproducibility
12 months
Women with suspected deep infiltrating endometriosis of the posterior compartment involving the rectum or rectosigmoid colon who are scheduled for surgical treatment.
Giorgia Gaia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
First Submitted
April 1, 2026
First Posted
April 8, 2026
Study Start
April 7, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
April 7, 2027
EstimatedRelugolix for Endometriosis Associated Pain
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 7, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 8, 2026
Record last verified: 2026-03
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