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Ultrasound Evaluation for Improving Patient Selection in vNOTES

NCT05623514 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2024-11-14

No results posted yet for this study

Summary

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.

Conditions

  • Surgery

Interventions

COMBINATION_PRODUCT

Trans-vaginal ultrasound

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

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Aya Mohr-Sasson · The University of Texas Health Science Center, Houston, TX

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-16
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05623514 on ClinicalTrials.gov