Intraoperative Sono-assessment In Deep Endometriosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Endometriosis, Endometriosis-related Pain, Pelvic Pain Syndrome, Endometriosis, Rectum. Basic parameters: 20 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Intraoperative Ultrasound in Rectal Shaving for Deep Infiltrating Endometriosis: Evaluation of Residual Disease, Bowel Wall Thickness, and Clinical Outcomes
Overview
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.
Primary outcome measures
- Change in Gastrointestinal Symptoms and Quality of Life Scores [Time frame: 12 months]
Secondary outcome measures (2)
- Association Between Residual Bowel Wall Thickness and Surgical Complications [Time frame: 12 months]
- Identification of Predictive Ultrasound Cut-off Values [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07517081 · 27052