Ultrasound Evaluation for Improving Patient Selection in vNOTES

ConditionSurgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorThe University of Texas Health Science Center, Houston

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

History of radiation to the pelvis

Malignancy

Combined current vaginal operation (for the treatment of prolapse/ urinary complaints)

Trial population

Women who are patients at UT Physicians gynecological clinics, are planned to undergo benign gynecological surgery (hysterectomy or adnexectomy) with normal vaginal examination (normal mobility of the uterus), and are considered for the vNOTES surgical approach.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Trans-vaginal ultrasound

    Diagnostic test

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

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: Candidates for the vaginal natural orifice trans-luminal surgery (vNOTES) approach1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Operative complication rate

Operative complications include organ damage (damage caused during the surgery to the bladder, the rectum or blood vessel), bleeding, and vascular damage.

Time frame
during the operation
2

Post-operative complication rate

Post-operative complications include surgical site infection (SSI), dyspareunia, vaginal bleeding, re-hospitalization, and pain.

Time frame
from operation until one month post-operation
3

Operation time

Time frame
during the operation

Other outcomes

Sponsors and contacts

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