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Not Yet Recruiting NCT05623514

Ultrasound Evaluation for Improving Patient Selection in vNOTES

Conditions: Surgery

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: 1
Phase: NA
Enrollment: 75
Sponsor: The University of Texas Health Science Center, Houston

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.

Eligibility Criteria

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05623514). StuddyBuddy aggregates publicly available trial information.