vNOTES Versus Vaginal Hysterectomy for Benign Gynecologic Indications
Comparison of Early and Late Postoperative Outcomes of vNOTES and Vaginal Hysterectomy in Benign Gynecological Indications: A Randomized Non-Inferiority Trial
- Hysterectomy, Benign Uterine Diseases
At a glance
- Phase
- Phase not stated
- Study type
- Interventional
- Sponsor
- Hatice Nur ÖZGEN
- Enrolment target
- 30
- Started
- 20 April 2026
- Main results due
- 30 June 2027
- Study sites
- 1
- Registry updated
- 29 September 2026
Can you take part?
- Ages 18 years to 65 years.
- Women only.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(1)
Harran University Hospital
Sanliurfa, Şanlıurfa, Turkey (Türkiye)
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07846670. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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