Endometriosis, Endometriosis of Colon, Endometriosis, Rectum, Endometriosis-related Pain, Pelvic Pain Syndrome
Conditions
Brief summary
Deep infiltrating endometriosis (DIE) involving the bowel, particularly the rectosigmoid region, is associated with significant gastrointestinal symptoms and impaired quality of life. Rectal shaving is a conservative surgical technique aimed at removing endometriotic lesions while preserving bowel integrity; however, it may result in residual disease or excessive thinning of the bowel wall, potentially leading to recurrence or complications. Intraoperative ultrasound (IOUS) allows real-time assessment of residual nodule thickness and bowel wall thickness after shaving. This prospective observational study aims to evaluate the relationship between intraoperative ultrasound measurements and postoperative clinical outcomes, including gastrointestinal symptoms and quality of life. The study also seeks to identify ultrasound cut-off values that may guide intraoperative surgical decision-making and optimize the balance between radicality and safety.
Detailed description
Endometriosis affects approximately 7-10% of women of reproductive age and is frequently associated with delayed diagnosis. Deep infiltrating endometriosis involving the posterior compartment often causes gastrointestinal symptoms such as dyschezia, constipation, diarrhea, and rectal bleeding. Surgical management of bowel DIE includes conservative approaches (rectal shaving) and radical procedures (disc excision or segmental resection). Current guidelines emphasize individualized treatment decisions. Rectal shaving avoids bowel resection and is associated with lower morbidity but carries risks of residual disease and bowel wall thinning. Intraoperative ultrasound enables precise measurement of residual lesions and bowel wall thickness, potentially improving surgical outcomes. This study evaluates whether: * Greater residual nodule thickness is associated with persistent or recurrent symptoms; * Reduced bowel wall thickness is associated with increased postoperative complications.
Interventions
None listed
Sponsors
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Female patients aged 20-60 years * Rectal or sigmoid nodule with muscularis propria infiltration ≥1 mm and \<20 mm (assessed by expert transvaginal ultrasound) * Indication for surgery agreed upon with the patient * Written informed consent
Exclusion criteria
* Previous major bowel surgery or primary indication for bowel resection * Inflammatory bowel disease, malignancy, or severe pelvic pathology * Inability to complete study questionnaires
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gastrointestinal Symptoms and Quality of Life Scores | 12 months | Change in gastrointestinal symptom severity and quality of life (PAC-SYM and PAC-QOL scores) from baseline to 12 months, stratified by depth of muscular infiltration (1-6 mm, 7-12 mm, 13-20 mm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Association Between Residual Bowel Wall Thickness and Surgical Complications | 12 months | Evaluation of the relationship between intraoperatively measured minimum residual bowel wall thickness at the site of rectal shaving and the occurrence of postoperative complications, including bowel perforation, rectovaginal fistula, anastomotic stenosis, and other complications. |
| Identification of Predictive Ultrasound Cut-off Values | 12 months | Identification of predictive cut-off values for intraoperative ultrasound parameters (e.g., residual nodule thickness, depth of infiltration, and bowel wall thickness) associated with postoperative outcomes and surgical complexity. |
Contacts
CONTACTGiorgia Gaia
PRINCIPAL_INVESTIGATORGiorgia Gaia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Outcome results
None listed