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UNKNOWNNANCT05971875

RCT on 3 Types of 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

Lead sponsor: Dr Jan Baekelandt, MD•2 locations•View source on ClinicalTrials.gov

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Contacts

Jan Baekelandt, Prof

CONTACT

0032499471371 jan.baekelandt@imelda.be

Jan Baekelandt

CONTACT

0032499471371 jan.baekelandt@imelda.be

Sponsors

Lead Sponsor

Dr Jan Baekelandt, MD

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.

Age

18 - 75 years

Sex

FEMALE

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 22, 2024Terms

Trial snapshot

StatusUNKNOWN

PhaseNA

Enrollment1,000

Start dateJan 2024

Last updatedMar 22, 2024

Condition

Minimally Invasive Surgery

Locations shown

Dept of Obstetrics and Gynecology

Zadar

Dept of Obstetrics and Gynecology

Helsingborg

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 22, 2024Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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