RCT on 3 Types of Hysterectomy
VANOLAH
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.
1 other identifier
interventional
1,000
2 countries
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2024
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2023
CompletedFirst Posted
Study publicly available on registry
August 2, 2023
CompletedStudy Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedMarch 22, 2024
March 1, 2024
2 years
July 7, 2023
March 20, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
proportion of women leaving the hospital within 12 hours after surgery complications.
Day sugery
12 hours
Secondary Outcomes (7)
Hospitalization time
6 weeks
conversion rates
12 hours
duration of the surgical procedure
12 hours
Intraoperative complications.
12 hours
postoperative complications,
6 weeks
- +2 more secondary outcomes
Study Arms (2)
vNOTES vs Vaginal Hysterectomy
ACTIVE COMPARATORGroup A: If VH is concidered safe and feasable; the patient is randomized between VH and vNOTES
vNOTES vs Laparoscopic Hysterectomy
ACTIVE COMPARATORIf VH is not concidered safe and feasable; The patient is randomized between LH and vNOTES
Interventions
Comparison of vNOTES vs LH
Eligibility Criteria
You may qualify if:
- Women aged 18 to 75 years regardless of parity with benign indication for hysterectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Dept of Obstetrics and Gynecology
Zadar, Croatia
Dept of Obstetrics and Gynecology
Helsingborg, 25438, Sweden
Related Publications (1)
Baekelandt JF, Stuart A, Wagenius J, Laenen A, Mol BW, Deprest J, Bosteels JJA. VaNoLaH trial: a study protocol-a multinational randomised controlled trial including two identical substudies comparing vaginal versus vNOTES (vaginal natural orifice transluminal surgery) hysterectomy or laparoscopic versus vNOTES hysterectomy. BMJ Open. 2024 Apr 23;14(4):e081979. doi: 10.1136/bmjopen-2023-081979.
PMID: 38658010DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
JAn Baekelandt
Imeldaziekenhuis
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Prof
Study Record Dates
First Submitted
July 7, 2023
First Posted
August 2, 2023
Study Start
January 1, 2024
Primary Completion
January 1, 2026
Study Completion
January 1, 2026
Last Updated
March 22, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share