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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Kontakte und Standorte
Studienkontakt
- Name: Hatice N ÖZGEN, PhD
- Telefonnummer: +90-505-494-40-88
- E-Mail: haticenurozgen@harran.edu.tr
Studienorte
-
-
Şanlıurfa
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Sanliurfa, Şanlıurfa, Türkei (türkiye), 63300
- Rekrutierung
- Harran University Hospital
-
Kontakt:
- Hatice N ÖZGEN, PhD
- Telefonnummer: +90-505-494-40-88
- E-Mail: haticenurozgen@harran.edu.tr
-
Hauptermittler:
- Hatice N ÖZGEN, PhD
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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. |
|
Aktiver Komparator: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Postoperative pain score
Zeitfenster: 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
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Studienleiter: Fatma KORUK, PhD, Harran University Faculty of Health Sciences
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- HRU-VNOTES-RCT-2026
Plan für individuelle Teilnehmerdaten (IPD)
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