NCT06776536

Evaluation of Rectal Infiltration Depth and Length in Bowel Involvement of Deep Infiltrative Endometriosis (DIE) Using Intraoperative Transrectal Ultrasound (TRUS)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Başakşehir Çam & Sakura City Hospital · Other Government
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

we aim to evaluate the success of intraoperative transrectal ultrasound in measuring the depth and extent of bowel involvement in patients preoperatively diagnosed with intestinal endometriosis using transvaginal ultrasound and MRI, and who are planned for bowel resection

Detailed description

This is a prospective, single-arm study aimed at evaluating the efficacy of intraoperative transrectal ultrasound (TRUS) in assessing rectal infiltration depth and length in patients with bowel involvement due to deep infiltrative endometriosis (DIE). The study will include 15-40 female patients aged 18-55, diagnosed with intestinal endometriosis preoperatively using transvaginal ultrasound and MRI, and scheduled for bowel resection. Preoperative evaluations will include pelvic examination, imaging (TVUS and MRI), and pain assessment using a visual analog scale (VAS). During surgery, TRUS will be used to measure the depth and length of rectal involvement, and findings will be compared with preoperative MRI results. Data will be analyzed using statistical methods, including sensitivity, specificity, and ROC curve analysis, to determine the diagnostic performance of TRUS. The study will be conducted at Istanbul Başakşehir Çam and Sakura City Hospital, with multidisciplinary contributions from gynecology, radiology, and general surgery teams.

Conditions

• Deep Infiltrating Endometriosis (DIE)
• Transrectal Ultrasound
• Bowel Endometriosis
• Bowel Resection

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Transrectal ultrasound of the bowel endometriosis during operation	This is a prospective, single-arm study aimed at evaluating the efficacy of intraoperative transrectal ultrasound (TRUS) in assessing rectal infiltration depth and length in patients with bowel involvement due to deep infiltrative endometriosis (DIE). The study will include 15-40 female patients aged 18-55, diagnosed with intestinal endometriosis preoperatively using transvaginal ultrasound and MRI, and scheduled for bowel resection. Preoperative evaluations will include pelvic examination, imaging (TVUS and MRI), and pain assessment using a visual analog scale (VAS). During surgery, TRUS will be used to measure the depth and length of rectal involvement, and findings will be compared with preoperative MRI results.

Timeline

• Start date: 2025-01-07
• Primary completion: 2026-04-07
• Completion: 2026-04-07
• First posted: 2025-01-15
• Last updated: 2025-01-15

Locations

1 site across 1 country: Turkey (Türkiye)