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
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
This prospective, randomized, non-inferiority controlled trial is designed to compare transvaginal natural orifice transluminal endoscopic surgery (vNOTES) hysterectomy and vaginal hysterectomy in women with benign gynecological indications requiring hysterectomy.
The study will be conducted at Harran University Hospital after ethics committee approval and clinical trial registration. Eligible participants will include women aged 18-65 years who are suitable candidates for both surgical techniques. Patients with gynecological malignancy, severe endometriosis, advanced uterine prolapse, pregnancy, active pelvic infection, or high surgical risk will be excluded.
Participants will be randomized in a 1:1 ratio to either the vNOTES hysterectomy group or the vaginal hysterectomy group using computer-based block randomization. All surgical procedures will be performed by an experienced surgeon. Although blinding of surgeons and participants is not feasible, postoperative outcome assessments and statistical analyses will be conducted by blinded researchers.
The primary outcome measure is postoperative pain at 24 hours assessed using the Visual Analog Scale (VAS). Secondary outcomes include postoperative recovery, return of bowel motility, urinary catheter duration, hospital stay, postoperative complications according to the Clavien-Dindo classification, readmission rates, and postoperative recovery index scores.
Data will be collected during the preoperative, intraoperative, and postoperative periods using standardized forms. Patients will be evaluated on postoperative day 0, day 1, day 7, and at postoperative month 1.
Statistical analyses will be performed using SPSS software. Appropriate parametric or non-parametric tests will be used according to data distribution. Non-inferiority analysis will be performed using the 95% confidence interval of the between-group difference for the primary outcome.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Hatice N ÖZGEN, PhD
- Telefoonnummer: +90-505-494-40-88
- E-mail: haticenurozgen@harran.edu.tr
Studie Locaties
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Şanlıurfa
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Sanliurfa, Şanlıurfa, Turkije (Türkiye), 63300
- Werving
- Harran University Hospital
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Contact:
- Hatice N ÖZGEN, PhD
- Telefoonnummer: +90-505-494-40-88
- E-mail: haticenurozgen@harran.edu.tr
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Hoofdonderzoeker:
- Hatice N ÖZGEN, PhD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: vNOTES Hysterectomy
Participants undergo hysterectomy using the transvaginal natural orifice transluminal endoscopic surgery (vNOTES) technique. |
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. |
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Actieve vergelijker: Vaginal Hysterectomy
Participants undergo conventional vaginal hysterectomy using the standard vaginal surgical approach. |
Conventional vaginal hysterectomy performed for benign gynecologic indications using the standard vaginal surgical approach. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Postoperative pain score
Tijdsspanne: 24 hours after surgery
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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
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Studie directeur: Fatma KORUK, PhD, Harran University Faculty of Health Sciences
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- HRU-VNOTES-RCT-2026
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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