Status:
RECRUITING
RCT on 3 Types of Hysterectomy
Lead Sponsor:
Dr Jan Baekelandt, MD
Conditions:
Minimally Invasive Surgery
Eligibility:
FEMALE
18-75 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- • Women aged 18 to 75 years regardless of parity with benign indication for hysterectomy
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT05971875
Start Date
January 1 2024
End Date
January 1 2026
Last Update
March 22 2024
Active Locations (2)
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1
Dept of Obstetrics and Gynecology
Zadar, Croatia
2
Dept of Obstetrics and Gynecology
Helsingborg, Sweden, 25438