Intraoperative Ultrasound in Bowel Deep Endometriosis

NCT ID: NCT06876376

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-20
• Study Completion Date: 2027-06-30

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.

Conditions

Deep Infiltrating Endometriosis With or Without Bowel Involvement

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

posterior compartment deep infiltrating endometriosis

intraoperative ultrasound for the assessment of bowel deep infiltrating endometriosis

Intervention Type: PROCEDURE

Women with posterior compartment deep infiltrating endometriosis with or without bowel involvement scheduled for surgical treatment at the Department of Obstetrics, Gynecology, and Reproductive Medicine of Dexeus University Hospital.

Interventions

intraoperative ultrasound for the assessment of bowel deep infiltrating endometriosis

Women with posterior compartment deep infiltrating endometriosis with or without bowel involvement scheduled for surgical treatment at the Department of Obstetrics, Gynecology, and Reproductive Medicine of Dexeus University Hospital.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fundacion Dexeus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Yannick Hurni, MD

Role: CONTACT

yanhur@dexeus.com

0034932274700

Ignacio Rodríguez, MSc

Role: CONTACT

nacrod@dexeus.com

0034932274700 ext. 22029

Facility Contacts

Ignacio Rodríguez, BsC

Role: primary

nacrod@dexeus.com

0034932274700 ext. 22029

References

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Reference Type: BACKGROUND

PMID: 15541453 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 15947176 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 21718982 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Abrao MS, Andres MP, Barbosa RN, Bassi MA, Kho RM. Optimizing Perioperative Outcomes with Selective Bowel Resection Following an Algorithm Based on Preoperative Imaging for Bowel Endometriosis. J Minim Invasive Gynecol. 2020 May-Jun;27(4):883-891. doi: 10.1016/j.jmig.2019.06.010. Epub 2019 Jun 22.

Reference Type: BACKGROUND

PMID: 31238150 (View on PubMed)

Puppo A, Olearo E, Gattolin A, Rimonda R, Novelli A, Ceccaroni M. Intraoperative Ultrasound for Bowel Deep Infiltrating Endometriosis: A Preliminary Report. J Ultrasound Med. 2021 Jul;40(7):1417-1425. doi: 10.1002/jum.15511. Epub 2020 Sep 29.

Reference Type: BACKGROUND

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Related Links

http://www.dexeus.com

Related Info

Other Identifiers

FSD-DIE-2024-18

Identifier Type: -

Identifier Source: org_study_id