RCT on 3 Types of Hysterectomy (VANOLAH)

Dr Jan Baekelandt, MD

Status: Enrolling

Conditions: Minimally Invasive Surgery

Treatments: Procedure: vNOTES vs Vaginal Hysterectomy; Procedure: vNOTES vs Laparoscopic Hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT05971875

Vanolah

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,000 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,000 participants in 2 patient groups

vNOTES vs Vaginal Hysterectomy

Active Comparator group

Description:

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

Treatment:

Procedure: vNOTES vs Vaginal Hysterectomy

vNOTES vs Laparoscopic Hysterectomy

Active Comparator group

Description:

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

Treatment:

Procedure: vNOTES vs Laparoscopic Hysterectomy