Ultrasound Evaluation for Improving Patient Selection in vNOTES (PUP-VNOTES)

November 12, 2024 updated by: Aya Mohr Sasson, The University of Texas Health Science Center, Houston

Pre-surgical Ultrasound Evaluation for Improving Patient Selection for vNOTES Approach

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is an emerging field in minimally invasive surgery. It has gained the most popularity compared to other transluminal natural orifices such as mouth, rectum or urinary tract. By incorporating the advantages of endoscopic surgery, the vNOTES approach avoids abdominal wall wounds and trocar-related complications. Recent studies report reduced postoperative pain, accelerated postoperative recovery, and decreased postoperative wound infections, as well as achieving highly satisfying cosmetic results. All these made this technique very appealing to surgeons and patients alike.

The feasibility and safety of vNOTES in gynecologic surgeries, was first introduced by Ahn et al. in 2012 that performed vNOTES in ten women with benign uterine adnexal disease. Since then, surgeons have developed the technique in various benign gynecologic surgeries indications. There has been an exponential uptake of the number of surgeons performing vNOTES procedures worldwide with no official guidance to ensure the safe implementation of this technique into gynecological practice. The novelty of the technique is still a matter of concern in sub-populations and different indications.

International consensus-based statement was recently published based on Delphi consensus of expert panel to help guide the basis for adopting vNOTES into clinical practice with respect to eight key domains including patient selection. It was agreed that women with potential adhesions are not appropriate candidates for vNOTES approach including women with a history of a severe PID that is considered contraindication. 97.4% of the experts agreed that it is not necessary to perform a preoperative vaginal culture if the patient is asymptomatic. However, as some pelvic infections might be asymptomatic such as with chlamydia, pre-operation imaging might be beneficial to complete proper patient selection for the vNOTES approach. Moreover, women with previous severe PID infection might still have favorable pelvic to perform the vNOTES approach Aim: To the best of our knowledge no guidelines have been published regarding the pre-operation evaluation and the imaging characteristics. Due to the aforementioned, the aim of our study is to compare pre-operation ultrasound evaluation to operative characteristics and outcomes.

Material and Methods This is a prospective cohort study that will be conducted in a single tertiary medical center. Study population will include all women planned for surgery due to benign indication (adnexectomy/ hysterectomy) that vNOTES approach is considered and have normal vaginal examination (normal mobility of the uterus). Women with history of pelvic radiation, suspected malignancy or combined operations will be excluded from the study.

Intervention:

  1. As part of the evaluation at the pre-operation clinics, women will complete vaginal examination to assess for pelvic organs mobility and potential adhesions.
  2. Trans-vaginal examination will be completed to evaluate uterus and adnexal characteristics in addition to sliding sign between the uterus to the rectum for the evaluation of the Douglas space.
  3. Women with normal ultrasound evaluation and a positive sliding sign will continue with surgery via the vNOTES approach. Women with limited mobility demonstrated on ultrasound will be recommended alternative surgical approaches.

3-Swabs will be collected for potential PID pathogens including chlamydia, gonorrhea, trichomonas and mycoplasma.

4-Operation report- will include information regarding pelvic adhesions, location of the adhesions and abdominal screening (Including diaphragm and liver area). For the study group undergoing vNOTES approach surgery - difficulty to complete anterior or posterior colpotomy will be documented.

Douglas space characteristics 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.

Demographic and clinical characteristics will be collected from women's medical files. Operative and post-operative data will be collected including: operation duration, estimated blood loss, operation complications (hypotension, bladder gut or vascular perforation), post-operative complications (hemorrhage, endometritis, vascular - thromboembolic event, ileus).

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Candidates for vaginal natural orifice trans-luminal surgery approach
Candidates for benign gynecological surgery in the vaginal natural orifice trans-luminal surgery approach
Combination product: Trans-vaginal ultrasound
Pre-operative trans-vaginal ultrasound in order to evaluate sliding sign between the uterus and the rectum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
From recruitment in the clinics until one month post operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Organ damage
Time Frame: From operation until one month post-operation
Damage caused during the surgery to the bladder, the rectum or blood vessel
From operation until one month post-operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Aya Mohr-Sasson, The University of Texas Health Science Center, Houston, TX

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2022

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

November 10, 2022

First Submitted That Met QC Criteria

November 11, 2022

First Posted (Actual)

November 21, 2022

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

November 12, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HSC-MS-22-0947

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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