Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Change in Gastrointestinal Symptoms and Quality of Life Scores | 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) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Association Between Residual Bowel Wall Thickness and Surgical Complications | 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. | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
The study population consists of women of reproductive age diagnosed with deep infiltrating endometriosis involving the rectum or sigmoid colon, with muscularis propria infiltration between 1 and 20 mm as assessed by expert preoperative transvaginal ultrasound. Eligible patients are those scheduled to undergo laparoscopic rectal shaving as part of standard clinical care at a tertiary referral center for endometriosis. All participants provide written informed consent prior to enrollment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Giorgia Gaia | Contact | +393384406299 | giorgia.gaia@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| Giorgia Gaia | Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Principal Investigator |
Not provided
Not provided
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Identification of Predictive Ultrasound Cut-off Values | 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. | 12 months |
| D000091662 | Genital Diseases |