RCT on 3 Types of Hysterectomy

Not Applicable

Recruiting

• Conditions: Minimally Invasive Surgery
• Interventions: Procedure: vNOTES vs Laparoscopic Hysterectomy; Procedure: vNOTES vs Vaginal Hysterectomy

• Registration Number: NCT05971875
• Lead Sponsor: Dr Jan Baekelandt, MD

Brief Summary

A randomized controlled trial comparing the vaginal, vNOTES ( vaginal natural orifice transluminal surgery) or laparoscopic approach for hysterectomy in women with benign gynaecological disease

Detailed Description

Multi-center pragmatic non-blinded RCT including 1000 women 18-75 years in need of hysterectomy for benign disease; comparing VH vs vNOTES or LH vs vNOTES.

Study Timeline

• Study First Submitted: 2023-07-07
• Study First Submitted QC: 2023-08-01
• Study First Posted: 2023-08-02
• Study Start: 2024-01-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-22
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

• Women aged 18 to 75 years regardless of parity with benign indication for hysterectomy

Exclusion Criteria

• Women with a stage II+ prolapse in need of a hysterectomy as part of vaginal prolapse repair
• hysterectomy due to suspected endometriosis
• subtotal hysterectomy
• history of rectal surgery
• suspected malignancy
• suspected obliteration of the pouch of Douglas following severe PID or other causes
• active lower genital tract infection
• pregnancy
• failure to provide written informed consent prior to surgery
• requirement of in-patient care due to other co-morbidities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
vNOTES vs Laparoscopic Hysterectomy	vNOTES vs Laparoscopic Hysterectomy	If VH is not concidered safe and feasable; The patient is randomized between LH and vNOTES
vNOTES vs Vaginal Hysterectomy	vNOTES vs Vaginal Hysterectomy	Group A: If VH is concidered safe and feasable; the patient is randomized between VH and vNOTES

Primary Outcome Measures

Name	Time	Method
proportion of women leaving the hospital within 12 hours after surgery complications.	12 hours	Day sugery

Secondary Outcome Measures

Name	Time	Method
postoperative complications,	6 weeks	Clavien Dindo
conversion rates	12 hours	conversion to different surgival technique
re-admission requiring hospitalization	6 weeks	Readminssion
Patient Reported Outcome Measures.	3 months postop	Short Female Sexual Function Index.
duration of the surgical procedure	12 hours	from placement of Foley to last stich
Hospitalization time	6 weeks	Time admitted
Intraoperative complications.	12 hours	Complication

Trial Locations

Locations (1)

Dept of Obstetrics and Gynecology; 🇸🇪 Helsingborg, Sweden