Recruiting

Ultrasound Evaluation

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT05623514

Conditions

Surgery

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Trans-vaginal ultrasound

Study Details

Brief 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

Study ID

NCT05623514

Start date

May 16, 2022

Status verified date

Nov, 2024

Completion date

Dec, 2025

Anticipated

Primary completion date

Dec, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

75 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

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

Interventions

Trans-vaginal ultrasound

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

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 and Locations

Central contacts

Locations

University of Texas

Recruiting

Houston, Texas, United States, 77030

Contacts

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Nov 14, 2024

Last verified

Nov, 2024

Keywords

  • vaginal surgery
  • trans-vaginal ultrasound examination
  • sliding sign

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2024-11-14.