Ultrasound Evaluation for Improving Patient Selection in vNOTES

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT05623514
Status
Recruiting
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Conditions

  • Surgery

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Trans-vaginal ultrasound — COMBINATION_PRODUCT
    Pre-operative trans-vaginal ultrasound in order to evaluate sliding sign between the uterus and the rectum

Study Details

Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is an emerging field in minimally invasive surgery. International consensus-based statement was recently published to help guide the basis for adopting vNOTES into clinical practice, including regarding patient selection. It was agreed that women with potential adhesions are not appropriate candidates for vNOTES approach including women with suspected adhesions due to history of severe pelvic inflammatory disease (PID) or endometriosis. However, as some pelvic infections might be asymptomatic, pre-operation imaging might be beneficial to complete improved selection of patients. Moreover, women with previous severe PID or endometriosis might still have favorable pelvic to perform the vNOTES approach. Therefore, we aim to compare pre-operation ultrasound evaluation to operative characteristics and outcomes in women undergoing VNOTES approach surgery.

Key Dates

Start date
May 16, 2022
Status verified
Nov 2024
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
75 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Candidates for vaginal natural orifice trans-luminal surgery approach
    Candidates for benign gynecological surgery in the vaginal natural orifice trans-luminal surgery approach

Primary Outcome Measure

The rate of adhesions/ complicated entry to the Douglas space reported during surgery. [ Time Frame: From recruitment in the clinics until one month post operation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of TexasHoustonTexas77030
Aya Mohr-Sasson, M.D
[email protected]
346-270-4682
Sunbola Ashimi
[email protected]

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By research site
University of Texas· Houston, TX

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