RCT on 3 Types of Hysterectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-01-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Minimally Invasive Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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vNOTES vs Vaginal Hysterectomy

Group A: If VH is concidered safe and feasable; the patient is randomized between VH and vNOTES

Group Type ACTIVE_COMPARATOR

vNOTES vs Vaginal Hysterectomy

Intervention Type PROCEDURE

Comparison of vNOTES vs VH

vNOTES vs Laparoscopic Hysterectomy

If VH is not concidered safe and feasable; The patient is randomized between LH and vNOTES

Group Type ACTIVE_COMPARATOR

vNOTES vs Laparoscopic Hysterectomy

Intervention Type PROCEDURE

Comparison of vNOTES vs LH

Interventions

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vNOTES vs Vaginal Hysterectomy

Comparison of vNOTES vs VH

Intervention Type PROCEDURE

vNOTES vs Laparoscopic Hysterectomy

Comparison of vNOTES vs LH

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No