RecruitingNot ApplicableNCT05971875
RCT on 3 Types of Hysterectomy
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.
Sponsor
Dr Jan Baekelandt, MD
Enrollment
1,000 participants
Start Date
Jan 1, 2024
Study Type
INTERVENTIONAL
Conditions
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
Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years
Inclusion Criteria1
- • Women aged 18 to 75 years regardless of parity with benign indication for hysterectomy
Exclusion Criteria10
- 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
Interventions
PROCEDUREvNOTES vs Vaginal Hysterectomy
Comparison of vNOTES vs VH
PROCEDUREvNOTES vs Laparoscopic Hysterectomy
Comparison of vNOTES vs LH
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05971875
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