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vNOTES Versus Vaginal Hysterectomy for Benign Gynecologic Indications

RecruitingNAAges 18 Years - 65 YearsFemaleHatice Nur ÖZGEN
NCT07846670 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • vNOTES Hysterectomy
  • Vaginal Hysterectomy
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Where

1 site
Harran University Hospital
Sanliurfa, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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