vNOTES Versus Vaginal Hysterectomy for Benign Gynecologic Indications

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorHatice Nur ÖZGEN

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • vNOTES Hysterectomy

    Procedure/Surgery

    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.

  • Vaginal Hysterectomy

    Procedure/Surgery

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: vNOTES HysterectomyExperimental treatment 1 intervention
Group B: Vaginal HysterectomyActive comparator 1 intervention

Trial outcomes

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).

Time frame
24 hours after surgery

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hatice Nur ÖZGEN

Lead sponsor

Harran University

Sponsor institution

Harran University

Collaborator