Deep Infiltrating Endometriosis With or Without Bowel Involvement
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Impact on Surgical Decision-Making | Day of surgery | o Changes in surgical strategy (shaving, discoid excision, or segmental resection) based on intraoperative ultrasound findings. |
| Postoperative Pain and Function | at 3-months, 6-months and 12-months follow-up | Improvement in pain symptoms and quality of life |
| Complication Rates | From day of surgery to 7 days later | o Frequency of intraoperative or postoperative complications (ClassIntra and Clavien-Dindo ≥ III). |
Countries
Spain