RCT on 3 Types of Hysterectomy (VANOLAH)

March 20, 2024 updated by: Dr Jan Baekelandt, MD

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.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Croatia
      • Zadar, Croatia
        • Recruiting
        • Dept of Obstetrics and Gynecology
        • Contact:
          • Luka Matak
  • Sweden
      • Helsingborg, Sweden, 25438
        • Recruiting
        • Dept of Obstetrics and Gynecology
        • Contact:
          • Andrea Stuart, phD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: vNOTES vs Vaginal Hysterectomy
Group A: If VH is concidered safe and feasable; the patient is randomized between VH and vNOTES
Procedure: vNOTES vs Vaginal Hysterectomy
Comparison of vNOTES vs VH
Active Comparator: vNOTES vs Laparoscopic Hysterectomy
If VH is not concidered safe and feasable; The patient is randomized between LH and vNOTES
Procedure: vNOTES vs Laparoscopic Hysterectomy
Comparison of vNOTES vs LH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
proportion of women leaving the hospital within 12 hours after surgery complications.
Time Frame: 12 hours
Day sugery
12 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Jan Baekelandt, MD

Investigators

  • Principal Investigator: JAn Baekelandt, Imeldaziekenhuis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

July 7, 2023

First Submitted That Met QC Criteria

August 1, 2023

First Posted (Actual)

August 2, 2023

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Vanolah

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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