RECRUITING Not applicable ClinicalTrials.gov

vNOTES Versus Vaginal Hysterectomy for Benign Gynecologic Indications

Sponsor: Hatice Nur ÖZGEN • ClinicalTrials.gov ID: NCT07846670

Registry updated: 2026-09-29

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

This randomized non-inferiority trial aims to compare early and late postoperative outcomes of transvaginal natural orifice transluminal endoscopic surgery (vNOTES) hysterectomy and vaginal hysterectomy in women undergoing hysterectomy for benign gynecological indications. Eligible participants will be randomly assigned to either vNOTES hysterectomy or vaginal hysterectomy. The primary outcome is postoperative pain at 24 hours measured by the Visual Analog Scale (VAS). Secondary outcomes include postoperative recovery, complications, length of hospital stay, return of bowel function, urinary catheter duration, readmission, and recovery index scores. The study will be conducted at Harran University Hospital.

Interventions

vNOTES Hysterectomy (Procedure)
Transvaginal natural orifice transluminal endoscopic surgery (vNOTES) hysterectomy performed for benign gynecologic indications. The procedure is conducted through a transvaginal endoscopic approach without abdominal incisions and is compared with conventional vaginal hysterectomy.
Vaginal Hysterectomy (Procedure)
Conventional vaginal hysterectomy performed for benign gynecologic indications using the standard vaginal surgical approach.

Eligibility criteria

Inclusion Criteria: Women aged 18-65 years. Presence of an indication for hysterectomy due to benign gynecological conditions (uterine leiomyoma, adenomyosis, treatment-resistant abnormal uterine bleeding, endometrial polyp, non-atypical endometrial hyperplasia, or high-grade cervical intraepithelial neoplasia). Uterine size corresponding to ≤14 weeks of gestation. Mobile uterus on gynecological examination. Vaginal access suitable for surgical intervention (absence of vaginal stenosis or severe anatomical restrictions). Considered eligible for both vaginal hysterectomy and vNOTES hysterectomy during preoperative evaluation. Provision of written informed consent. Exclusion Criteria: Confirmed or suspected gynecological malignancy. Active pelvic inflammatory disease or lower genital tract infection. History of rectal surgery or suspicion of rectovaginal endometriosis. Severe endometriosis or obliteration of the posterior cul-de-sac on pelvic examination. Stage III-IV uterine prolapse according to the International Continence Society (ICS) classification. Anatomical conditions that severely restrict vaginal access. Pregnancy or virginity.

Conditions

Hysterectomy, Benign Uterine Diseases

Locations

Harran University Hospital — Sanliurfa, Şanlıurfa, Turkey (Türkiye)

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment