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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Hatice N ÖZGEN, PhD
- Numéro de téléphone: +90-505-494-40-88
- E-mail: haticenurozgen@harran.edu.tr
Lieux d'étude
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Şanlıurfa
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Sanliurfa, Şanlıurfa, Turquie (Türkiye), 63300
- Recrutement
- Harran University Hospital
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Contact:
- Hatice N ÖZGEN, PhD
- Numéro de téléphone: +90-505-494-40-88
- E-mail: haticenurozgen@harran.edu.tr
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Chercheur principal:
- Hatice N ÖZGEN, PhD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
|
Comparateur actif: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Postoperative pain score
Délai: 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). |
24 hours after surgery
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Directeur d'études: Fatma KORUK, PhD, Harran University Faculty of Health Sciences
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HRU-VNOTES-RCT-2026
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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