Evaluating bowel involvement in deep infiltrative endometriosis using ultrasound during surgery
Evaluation of Rectal Infiltration Depth and Length in Bowel Involvement of Deep Infiltrative Endometriosis (DIE) Using Intraoperative Transrectal Ultrasound (TRUS)
This study is testing if a special ultrasound used during surgery can help doctors better understand how deep endometriosis affects the bowel in women who need surgery for it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | Female |
| Sponsor | Başakşehir Çam & Sakura City Hospital Government |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT06776536 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of intraoperative transrectal ultrasound (TRUS) in measuring the depth and extent of bowel involvement in patients diagnosed with deep infiltrative endometriosis (DIE) who are scheduled for bowel resection. It will include 15-40 female patients aged 18-55, with preoperative evaluations conducted using transvaginal ultrasound and MRI. During surgery, TRUS will be utilized to gather data on rectal infiltration, which will then be compared to preoperative imaging results. The study will analyze the diagnostic performance of TRUS through various statistical methods.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18-55 with bowel involvement due to deep infiltrative endometriosis requiring bowel resection.
Not a fit: Patients with bowel endometriosis who do not require bowel resection or have other bowel diseases like rectal tumors or Crohn's disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve surgical outcomes and precision in treating bowel endometriosis.
How similar studies have performed: While the use of transrectal ultrasound in this context is innovative, similar studies have shown promise in improving diagnostic accuracy for bowel conditions.
Eligibility criteria
Show full inclusion / exclusion 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. \-
Where this trial is running
Istanbul
- Basaksehir Cam ve Sakura City Hospital, Başakşehir Mahallesi G-434 Caddesi No: 2L Başakşehir / İSTANBUL — Istanbul, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Baris Kaya, Associate Professor,MD — Başakşehir Çam & Sakura City Hospital
- Study coordinator: Baris Kaya, Associate Professor
- Email: mdbariskaya@gmail.com
- Phone: +905323469156
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.