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

Last updated: January 10, 2025
Sponsor: Başakşehir Çam & Sakura City Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Endometriosis

Treatment

Transrectal ultrasound of the bowel endometriosis during operation

Clinical Study ID

NCT06776536
E-96317027-514.10-263823748
  • Ages 18-55
  • Female

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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

Total Participants: 15
Treatment Group(s): 1
Primary Treatment: Transrectal ultrasound of the bowel endometriosis during operation
Phase:
Study Start date:
January 07, 2025
Estimated Completion Date:
April 07, 2026

Study 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.

Connect with a study center

  • Basaksehir Cam ve Sakura City Hospital, Başakşehir Mahallesi G-434 Caddesi No: 2L Başakşehir / İSTANBUL

    Istanbul, 34480
    Turkey

    Active - Recruiting

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