Using ultrasound during surgery for bowel deep endometriosis
Intraoperative Transvaginal and Endorectal Ultrasound for the Assessment of Bowel Deep Infiltrating Endometriosis
This study is testing if using ultrasound during surgery for bowel deep endometriosis can help doctors see the problem better and improve recovery for patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fundacion Dexeus Academic / other |
| Locations | 1 site (Barcelona) |
| Trial ID | NCT06876376 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of intraoperative transvaginal and endorectal ultrasound in the surgical treatment of bowel deep infiltrating endometriosis. It aims to improve surgical outcomes by providing real-time imaging that helps assess the depth and extent of lesions, thereby guiding surgical decisions. Participants will undergo health and pain assessments before and after surgery to evaluate the impact of these techniques on their quality of life and postoperative pain management. The study seeks to enhance surgical precision and minimize unnecessary resections of healthy tissue.
Who should consider this trial
Good fit: Ideal candidates are women scheduled for surgical treatment of bowel deep infiltrating endometriosis with preoperative imaging suggesting bowel involvement.
Not a fit: Patients undergoing surgery solely for diagnostic purposes or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate surgeries and improved quality of life for patients with bowel deep infiltrating endometriosis.
How similar studies have performed: While intraoperative ultrasound has been explored in various surgical contexts, this specific application in bowel deep infiltrating endometriosis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Barcelona
- Departamento de Ginecología Obstetricia y Reproducción. Hospital Universitari Dexeus — Barcelona, Spain (Recruiting)
Study contacts
- Study coordinator: Yannick Hurni, MD
- Email: yanhur@dexeus.com
- Phone: 0034932274700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.