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Clinical Trials in Turkey / NCT07846670
Recruiting Not applicable

vNOTES Versus Vaginal Hysterectomy for Benign Gynecologic Indications

NCT07846670 · tracked via the Priya Life Science Turkey tracker
Sponsor
Hatice Nur ÖZGEN
Phase
Not applicable
Started
2026-04-20
Last updated
2026-09-29

Condition(s) studied

Hysterectomy, Benign Uterine Diseases

Investigational drug(s) / intervention(s)

vNOTES HysterectomyVaginal Hysterectomy

vNOTES Hysterectomy: 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: Conventional vaginal hysterectomy performed for benign gynecologic indications using the standard vaginal surgical approach.

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Postoperative pain score — 24 hours after surgery
    Postoperative pain will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).

Trial sites (1)

FacilityCityRegionStatus
Harran University Hospital Sanliurfa Şanlıurfa Recruiting

Other trials for the same condition

Effect of Abdominal Ice Pack After vNOTES Hysterectomy Enrolling by invitation
VNOTES and Vaginal Hysterectomy for Benign Indications Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07846670 on ClinicalTrials.gov ↗ ← All trials in Turkey