A Multinational Randomized Controlled Trial Including Two Identical Sub Studies Comparing Vaginal Versus vNOTES (Vaginal Natural Orifice Transluminal Surgery) Hysterectomy or Laparoscopic Versus vNOTES Hysterectomy.
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• • Women aged 18 to 75 years regardless of parity with benign indication for hysterectomy
Locations
Other Locations
Croatia
Dept of Obstetrics and Gynecology
RECRUITING
Zadar
Sweden
Dept of Obstetrics and Gynecology
RECRUITING
Helsingborg
Contact Information
Primary
Jan Baekelandt, Prof
jan.baekelandt@imelda.be
0032499471371
Backup
Jan Baekelandt
jan.baekelandt@imelda.be
0032499471371
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 1000
Treatments
Active_comparator: vNOTES vs Vaginal Hysterectomy
Group A: If VH is concidered safe and feasable; the patient is randomized between VH and vNOTES
Active_comparator: vNOTES vs Laparoscopic Hysterectomy
If VH is not concidered safe and feasable; The patient is randomized between LH and vNOTES
Related Therapeutic Areas
Sponsors
Leads: Dr Jan Baekelandt, MD