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OpenTrials
Completed

NCT Number: NCT00750035

Total Versus Subtotal Hysterectomy:a Randomised, Prospective Multicentre Study of the Effect on Urinary, Sexual and Bowel Function

Background

It is uncertain whether subtotal abdominal hysterectomy results in better bladder, bowel, or sexual function than total abdominal hysterectomy.

Methods

The investigators conducted a randomized, double-blind trial comparing total and subtotal abdominal hysterectomy in 279 women referred for hysterectomy because of benign disease; most of the women were premenopausal. The main outcomes were measures of bladder, bowel, and sexual function at 12 months. The investigators also evaluated postoperative complications.

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Key information

Conditions

Hysterectomy

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

St George's Healthcare NHS Trust

London, SW17 0QT, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women having abdominal hysterectomy for benign conditions of the uterus

Exclusion criteria

  • Suspected cancer
  • A body weight that exceeded 100 kg
  • Previous pelvic surgery
  • Known endometriosis
  • Abnormal cervical smears,
  • Symptomatic uterine prolapse
  • Symptomatic urinary incontinence

Treatment and study plan

Total abdominal hysterectomy

Procedure

Total abdominal hysterectomy and Subtotal abdominal hysterectomy

Subtotal abdominal hysterectomy

Procedure

Primary outcomes

  1. Main outcome measure was stress incontinence

    Time frame: Completed

Secondary outcomes

  1. Quality of life

    Time frame: Completed

Sponsors and collaborators

Lead sponsor

St George's Healthcare NHS Trust

Other

Registry information

Important dates

Study start
1996
Primary completion
2000
Study completion
2000
First posted
Sep 10, 2008
Registry last updated
Oct 24, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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