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RECRUITING
NCT05623514

Ultrasound Evaluation for Improving Patient Selection in vNOTES

Sponsor: The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

Summary

Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is an emerging field in minimally invasive surgery. An 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 characteristics 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. Douglas space characteristics, as assessed by ultrasound evaluation of sliding sign, of the patients undergoing vNOTES approach surgery will be compared to patients that were ruled from vNOTES approach in order to evaluate the association of the presence or absence of sliding sign on pre-operation ultrasound to the clinical findings.

Official title: Pre-surgical Ultrasound Evaluation for Improving Patient Selection for vNOTES Approach

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

75

Start Date

2022-05-16

Completion Date

2027-12

Last Updated

2026-10-01

Healthy Volunteers

Yes

Conditions

Interventions

DIAGNOSTIC_TEST

Trans-vaginal ultrasound

Pre-operative trans-vaginal ultrasound in order to evaluate sliding sign between the uterus and the rectum for the evaluation of the Douglas space

Locations (1)

University of Texas

Houston, Texas, United States