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Intraoperative Ultrasound in Bowel Deep Endometriosis

Intraoperative Transvaginal and Endorectal Ultrasound for the Assessment of Bowel Deep Infiltrating Endometriosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06876376
Enrollment
200
Registered
2025-03-14
Start date
2025-01-20
Completion date
2027-06-01
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Infiltrating Endometriosis With or Without Bowel Involvement

Keywords

Endometriosis, Intraoperative Ultrasound, Ultrasound, surgery, minimally invasive surgery

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.

Interventions

PROCEDUREintraoperative 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.

Sponsors

Fundacion Dexeus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Feasibility of intraoperative ultrasoundDay of surgeryo 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 ultrasoundDay of surgeryo Agreement between intraoperative ultrasound findings and histopathological results regarding the depth of infiltration and size of bowel DIE nodules.

Secondary

MeasureTime frameDescription
Impact on Surgical Decision-MakingDay of surgeryo Changes in surgical strategy (shaving, discoid excision, or segmental resection) based on intraoperative ultrasound findings.
Postoperative Pain and Functionat 3-months, 6-months and 12-months follow-upImprovement in pain symptoms and quality of life
Complication RatesFrom day of surgery to 7 days latero Frequency of intraoperative or postoperative complications (ClassIntra and Clavien-Dindo ≥ III).

Countries

Spain

Contacts

CONTACTYannick Hurni, MD
yanhur@dexeus.com0034932274700
CONTACTIgnacio Rodríguez, MSc
nacrod@dexeus.com0034932274700

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026