vNOTES hysterectomy compared with vaginal hysterectomy for benign gynecologic conditions
Official title: Comparison of Early and Late Postoperative Outcomes of vNOTES and Vaginal Hysterectomy in Benign Gynecological Indications: A Randomized Non-Inferiority Trial
Run by Harran University · NCT07846670 · Data updated 2026-11-12
This randomized trial tests whether vNOTES hysterectomy is not worse than vaginal hysterectomy for women needing a hysterectomy for benign reasons.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | Women only |
| Enrollment | 30 (estimated) |
| Sponsor | Harran University Academic / other |
| Locations | 1 site (Sanliurfa, Şanlıurfa) |
| Status | Recruiting |
| Started | April 20, 2026 |
| Main results expected | June 30, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | September 29, 2026 |
| Trial ID | NCT07846670 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18-65 with benign gynecologic indications for hysterectomy and suitable vaginal access, eligible for both vNOTES and vaginal hysterectomy.
✕Probably not a fit
Patients with gynecologic malignancy, active pelvic infection, severe endometriosis, or anatomical or clinical factors making one technique unsuitable may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, randomized, non-inferiority trial compares transvaginal natural orifice transluminal endoscopic surgery (vNOTES) hysterectomy with vaginal hysterectomy in women with benign gynecologic indications. The primary outcome is postoperative pain at 24 hours measured by a Visual Analog Scale, with secondary outcomes including recovery metrics, complications, length of hospital stay, return of bowel function, catheter duration, readmissions, and recovery scores. Surgeries are performed by experienced surgeons at Harran University Hospital, with blinded assessment of outcomes and analyses. Eligible participants are women aged 18-65 without malignancy or other exclusion criteria, randomized 1:1 to either procedure. Blinding of surgeons and participants is not feasible, but outcome assessors are blinded to reduce bias.
Why it matters
Potential benefit: If vNOTES performs similarly to or better than vaginal hysterectomy, patients may experience comparable or reduced postoperative pain and faster recovery.
How similar studies have gone: Prior studies in minimally invasive hysterectomy suggest potential benefits of alternative approaches, but this exact comparison in a non-inferiority framework is being evaluated in this trial.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Harran University Hospital
Sanliurfa, Şanlıurfa, Turkey (Türkiye) Recruiting
Study contacts
- Study coordinator: Hatice N ÖZGEN, PhD
- Email: haticenurozgen@harran.edu.tr
- Phone: +90-505-494-40-88
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.