Intraoperative Ultrasound in Bowel Deep Endometriosis

Last updated: March 13, 2025
Sponsor: Fundacion Dexeus
Overall Status: Active - Recruiting

Phase

N/A

Condition

Endometriosis

Treatment

intraoperative ultrasound for the assessment of bowel deep infiltrating endometriosis

Clinical Study ID

NCT06876376
FSD-DIE-2024-18
  • Ages > 18
  • Female

Study Summary

This study investigates the use of intraoperative transvaginal (IOTVUS) and/or endorectal ultrasound (IOERUS) in the surgical treatment of bowel deep infiltrating endometriosis (DIE).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Preoperative sonographic and/or MRI findings suggestive of bowel DIE (uterosacralligaments, posterior vaginal wall, parametrium, retrocervical area, rectovaginalseptum, rectum, and/or sigmoid colon).

  • Scheduled for surgical treatment (laparoscopy or robot-assisted laparoscopy).

  • Planned postoperative follow-up for at least 12 months.

  • Written informed consent provided before surgery.

Exclusion

Exclusion Criteria:

  • Planned surgery for diagnostic purposes only.

  • Pregnancy at the time of enrollment.

  • Poor understanding of Spanish or English.

Study Design

Total Participants: 200
Treatment Group(s): 1
Primary Treatment: intraoperative ultrasound for the assessment of bowel deep infiltrating endometriosis
Phase:
Study Start date:
January 20, 2025
Estimated Completion Date:
June 30, 2027

Study Description

Bowel DIE is a severe form of endometriosis that often infiltrates the rectum and the sigmoid colon, requiring precise surgical techniques to achieve complete excision while minimizing unnecessary resections of healthy tissues and organs. Current preoperative imaging techniques, such as transvaginal ultrasound and magnetic resonance imaging, are often limited in their ability to assess lesion depth and extent in cases of severe pelvic anatomical distortion. Intraoperative ultrasound offers a real-time evaluation after rectal mobilization, allowing for a more accurate assessment of lesion location, depth, and bowel wall infiltration. The primary objectives are to evaluate the feasibility and accuracy of intraoperative ultrasound in detecting rectal and RSJ DIE nodules and to guide surgical decision-making. Secondary objectives include determining the impact of these techniques on surgical outcomes, postoperative pain management, and quality of life. The goal is to enhance surgical decision-making by accurately assessing lesion depth and location, potentially reducing unnecessary colorectal resections or avoiding inadvertent retention of endometrial nodules. Participants will complete health and pain questionnaires preoperatively and at 3, 6, and 12 months postoperatively, evaluating dysmenorrhea, dyspareunia, dyschezia, and quality of life using validated tools. The study will also document intraoperative findings, surgical decisions, complications, and postoperative outcomes. By combining IOTVUS and IOERUS with existing surgical approaches, this study seeks to establish these techniques as standard tools for improving surgical precision in bowel DIE cases. Results could provide valuable insights for tailoring interventions to patient-specific disease presentations, enhancing long-term management strategies.

Connect with a study center

  • Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus

    Barcelona, 08037
    Spain

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.