Evaluation of Rectal Infiltration Depth and Length in Bowel Involvement of Deep Infiltrative Endometriosis (DIE) Using Intraoperative Transrectal Ultrasound (TRUS)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Başakşehir Çam & Sakura City Hospital
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Intraoperative transrectal ultrasound of the rectal involvement of the deep infiltrating endometriosis will be compared with preoperative MRI
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
we aim to evaluate the success of intraoperative transrectal ultrasound in measuring the depth and extent of bowel involvement in patients preoperatively diagnosed with intestinal endometriosis using transvaginal ultrasound and MRI, and who are planned for bowel resection
Detailed Description
This is a prospective, single-arm study aimed at evaluating the efficacy of intraoperative transrectal ultrasound (TRUS) in assessing rectal infiltration depth and length in patients with bowel involvement due to deep infiltrative endometriosis (DIE). The study will include 15-40 female patients aged 18-55, diagnosed with intestinal endometriosis preoperatively using transvaginal ultrasound and MRI, and scheduled for bowel resection. Preoperative evaluations will include pelvic examination, imaging (TVUS and MRI), and pain assessment using a visual analog scale (VAS). During surgery, TRUS will be used to measure the depth and length of rectal involvement, and findings will be compared with preoperative MRI results. Data will be analyzed using statistical methods, including sensitivity, specificity, and ROC curve analysis, to determine the diagnostic performance of TRUS. The study will be conducted at Istanbul Başakşehir Çam and Sakura City Hospital, with multidisciplinary contributions from gynecology, radiology, and general surgery teams.
Investigators
Baris KAYA
Associate Professori,MD
Başakşehir Çam & Sakura City Hospital
Eligibility Criteria
Inclusion Criteria
- •The study will include a minimum of 15 female patients aged 18-55 with bowel involvement due to deep infiltrative endometriosis, requiring bowel resection.
Exclusion Criteria
- •Patients with bowel endometriosis who does not require bowel resection, patients who have other bowel diseases, such as rectal tumors, Crohn's disease, or ulcerative colitis, will be excluded.
Outcomes
Primary Outcomes
Intraoperative transrectal ultrasound of the rectal involvement of the deep infiltrating endometriosis will be compared with preoperative MRI
Time Frame: From enrollment to the 16 months
Patients diagnosed with rectal endometriosis and planned for bowel resection will undergo intraoperative transrectal ultrasound during laparoscopy. The transrectal ultrasound will be performed by a blinded radiologist, and the location, depth, and length of rectal involvement in DIE will be measured in millimeters using TRUS. These findings will be recorded. The results will be compared with preoperative MRI results which was performed by another radiologist for this study.
Secondary Outcomes
- Demographic informations, patient characteristics, disease related pain scores, surgical informations(From enrollment to 16 months.)