Using ultrasound to improve patient selection for vaginal surgery
Pre-surgical Ultrasound Evaluation for Improving Patient Selection for vNOTES Approach
This study is testing if using trans-vaginal ultrasound can help doctors choose the right women for a specific type of minimally invasive vaginal surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05623514 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of trans-vaginal ultrasound in selecting appropriate candidates for Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES). The research aims to determine if pre-operative imaging can enhance patient selection, particularly for women with a history of pelvic inflammatory disease or endometriosis. By comparing ultrasound evaluations with surgical outcomes, the study seeks to improve the safety and efficacy of vNOTES procedures. This approach addresses the need for better guidelines in the rapidly evolving field of minimally invasive surgery.
Who should consider this trial
Good fit: Ideal candidates are women scheduled for hysterectomy or adnexal surgery who have normal vaginal examinations and are being considered for the vNOTES approach.
Not a fit: Patients with a history of pelvic radiation, malignancy, or those undergoing concurrent vaginal operations for prolapse or urinary issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective surgical options for women undergoing gynecologic procedures.
How similar studies have performed: While the vNOTES technique has shown promise in previous studies, this specific approach using ultrasound for patient selection is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: \- Women planned to undergo surgery for hysterectomy or adnexal indication with normal vaginal examination, that are considered for vNOTES approach. Exclusion criteria: * History of radiation to the pelvis * Malignancy * Combined current vaginal operation (for the treatment of prolapse/ urinary complaints)
Where this trial is running
Houston, Texas
- University of Texas — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Aya Mohr-Sasson — The University of Texas Health Science Center, Houston, TX
- Study coordinator: Aya Mohr-Sasson, M.D
- Email: aya.mohrsasson@uth.tmc.edu
- Phone: 13462704682
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.