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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Trans-vaginal ultrasound
Diagnostic testPre-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
Trial outcomes
Primary outcomes
The rate of adhesions/complicated entry to the Douglas space reported during surgery
Secondary outcomes
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.
Post-operative complication rate
Post-operative complications include surgical site infection (SSI), dyspareunia, vaginal bleeding, re-hospitalization, and pain.
Operation time
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