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

Not Applicable

Recruiting

• Conditions: Deep Infiltrating Endometriosis (DIE); Transrectal Ultrasound; Bowel Endometriosis; Bowel Resection

• Registration Number: NCT06776536
• Lead Sponsor: Başakşehir Çam & Sakura City Hospital

Brief 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.

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-07
• Study First Submitted: 2025-01-10
• Study First Submitted QC: 2025-01-10
• Last Update Submitted: 2025-01-10
• Study First Posted: 2025-01-15
• Last Update Posted: 2025-01-15
• Primary Completion: 2026-04-07
• Study Completion: 2026-04-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

• The study will include a minimum of 15 female patients aged 18-55 with bowel involvement due to deep infiltrative endometriosis, requiring bowel resection.

Exclusion Criteria

Patients with bowel endometriosis who does not require bowel resection, patients who have other bowel diseases, such as rectal tumors, Crohn's disease, or ulcerative colitis, will be excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Intraoperative transrectal ultrasound of the rectal involvement of the deep infiltrating endometriosis will be compared with preoperative MRI	From enrollment to the 16 months	Patients diagnosed with rectal endometriosis and planned for bowel resection will undergo intraoperative transrectal ultrasound during laparoscopy. The transrectal ultrasound will be performed by a blinded radiologist, and the location, depth, and length of rectal involvement in DIE will be measured in millimeters using TRUS. These findings will be recorded. The results will be compared with preoperative MRI results which was performed by another radiologist for this study.

Secondary Outcome Measures

Name	Time	Method
Demographic informations, patient characteristics, disease related pain scores, surgical informations	From enrollment to 16 months.	Patient demographic information, including age, BMI, known comorbidities, mode and number of deliveries, previous surgeries, and preoperative medical treatments, will be collected. Pain characteristics and visual analog score (VAS) scores for dysmenorrhea, dyspareunia, dysuria, dyschezia, and chronic pelvic pain will be retrieved from the hospital records or patient files. Surgical parameters, such as the type and duration of surgery will be recorded. Early postoperative complications will be recorded.

Trial Locations

Locations (1)

Basaksehir Cam ve Sakura City Hospital, Başakşehir Mahallesi G-434 Caddesi No: 2L Başakşehir / İSTANBUL; 🇹🇷 Istanbul, Turkey