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RCT on 3 Types of Hysterectomy

RCT on 3 Types of Hysterectomy

Recruiting
18-75 years
Female
Phase N/A

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Overview

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

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.

Eligibility

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 details
    Minimally Invasive Surgery

NCT05971875

Dr Jan Baekelandt, MD

8 March 2024

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