vNOTES Versus Vaginal Hysterectomy for Benign Gynecologic Indications

NCT07846670 | Recruiting

• 1 other identifier: HRU-VNOTES-RCT-2026
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hysterectomy, Benign Uterine Diseases

Keywords

vNOTES; Vaginal Hysterectomy; Benign Gynecologic Disease; Postoperative Outcomes

Outcome Measures

Primary Outcomes (1)

• Postoperative pain score

  Postoperative pain will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).

  24 hours after surgery

Study Arms (2)

vNOTES Hysterectomy

EXPERIMENTAL

Participants undergo hysterectomy using the transvaginal natural orifice transluminal endoscopic surgery (vNOTES) technique.

Procedure: vNOTES Hysterectomy

Vaginal Hysterectomy

ACTIVE COMPARATOR

Participants undergo conventional vaginal hysterectomy using the standard vaginal surgical approach.

Procedure: Vaginal Hysterectomy

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.

vNOTES Hysterectomy

Vaginal Hysterectomy PROCEDURE

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

Vaginal Hysterectomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hatice Nur ÖZGEN: lead
• Harran University: collaborator

Study Sites (1)

Harran University Hospital

Sanliurfa, Şanlıurfa, 63300, Turkey (Türkiye)

RECRUITING

MeSH Terms

Interventions

Hysterectomy, Vaginal

Intervention Hierarchy (Ancestors)

Hysterectomy; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Fatma KORUK, PhD

  Harran University Faculty of Health Sciences

  STUDY DIRECTOR

Central Study Contacts

Hatice N ÖZGEN, PhD

CONTACT

+90-505-494-40-88; haticenurozgen@harran.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer, PhD

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 29, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 29, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)