Intraoperative Ultrasound in Bowel Deep Endometriosis

Recruiting

• Conditions: Deep Infiltrating Endometriosis With or Without Bowel Involvement

• Registration Number: NCT06876376
• Lead Sponsor: Fundacion Dexeus

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2025-01-20
• Status Verified: 2025-03
• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-03-10
• Last Update Submitted: 2025-03-13
• Study First Posted: 2025-03-14
• Last Update Posted: 2025-03-17
• Primary Completion: 2027-02
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Preoperative sonographic and/or MRI findings suggestive of bowel DIE (uterosacral ligaments, posterior vaginal wall, parametrium, retrocervical area, rectovaginal septum, 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 Criteria

• Planned surgery for diagnostic purposes only.
• Pregnancy at the time of enrollment.
• Poor understanding of Spanish or English.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of intraoperative ultrasound	Day of surgery	o The proportion of patients in whom intraoperative ultrasound techniques can successfully identify rectal or rectosigmoid junction deep infiltrating endometriosis nodules during surgery.
Accuracy of intraoperative ultrasound	Day of surgery	o Agreement between intraoperative ultrasound findings and histopathological results regarding the depth of infiltration and size of bowel DIE nodules.

Secondary Outcome Measures

Name	Time	Method
Postoperative Pain and Function	at 3-months, 6-months and 12-months follow-up	Improvement in pain symptoms and quality of life
Impact on Surgical Decision-Making	Day of surgery	o Changes in surgical strategy (shaving, discoid excision, or segmental resection) based on intraoperative ultrasound findings.
Complication Rates	From day of surgery to 7 days later	o Frequency of intraoperative or postoperative complications (ClassIntra and Clavien-Dindo ≥ III).

Trial Locations

Locations (1)

Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus; 🇪🇸 Barcelona, Spain