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NCT Number: NCT06876376

Intraoperative Ultrasound in Bowel Deep Endometriosis

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus

Barcelona, 08037, Spain

Location status: Recruiting

Location contact

Ignacio Rodríguez, BsC

CONTACT

[email protected]

0034932274700 ext. 22029

Nuria Barbany-Freixa, MD

PRINCIPAL_INVESTIGATOR

Pere N Barri-Soldevila, MD

PRINCIPAL_INVESTIGATOR

Yannick Hurni, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

intraoperative ultrasound for the assessment of bowel deep infiltrating endometriosis

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.

Primary outcomes

  1. Feasibility of intraoperative ultrasound

    Time frame: 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.

  2. Accuracy of intraoperative ultrasound

    Time frame: Day of surgery

    o Agreement between intraoperative ultrasound findings and histopathological results regarding the depth of infiltration and size of bowel DIE nodules.

Secondary outcomes

  1. Impact on Surgical Decision-Making

    Time frame: Day of surgery

    o Changes in surgical strategy (shaving, discoid excision, or segmental resection) based on intraoperative ultrasound findings.

  2. Postoperative Pain and Function

    Time frame: at 3-months, 6-months and 12-months follow-up

    Improvement in pain symptoms and quality of life

  3. Complication Rates

    Time frame: From day of surgery to 7 days later

    o Frequency of intraoperative or postoperative complications (ClassIntra and Clavien-Dindo ≥ III).

Study contacts

Contact information is provided by the study sponsor or research team.

Ignacio Rodríguez, MSc

CONTACT

[email protected]

0034932274700 ext. 22029

Yannick Hurni, MD

CONTACT

[email protected]

0034932274700

Sponsors and collaborators

Lead sponsor

Fundacion Dexeus

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 14, 2025
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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