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

This study has been completed.
Sponsor:
Information provided by:
St George's Healthcare NHS Trust
ClinicalTrials.gov Identifier:
NCT00750035
First received: September 9, 2008
Last updated: October 23, 2008
Last verified: September 2008
  Purpose

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.


Condition Intervention
Hysterectomy
Procedure: Total abdominal hysterectomy
Procedure: Subtotal abdominal hysterectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by St George's Healthcare NHS Trust:

Primary Outcome Measures:
  • Main outcome measure was stress incontinence [ Time Frame: Completed ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: Completed ] [ Designated as safety issue: No ]

Enrollment: 279
Study Start Date: January 1996
Study Completion Date: April 2000
Primary Completion Date: April 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
total abdominal hysterectomy and
Procedure: Total abdominal hysterectomy
Total abdominal hysterectomy and Subtotal abdominal hysterectomy
Experimental: 2
Subtotal hysterectomy
Procedure: Subtotal abdominal hysterectomy

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00750035

Locations
United Kingdom
St George's Healthcare NHS Trust
London, United Kingdom, SW17 0QT
Sponsors and Collaborators
St George's Healthcare NHS Trust
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ranee Thakar, St George's Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT00750035     History of Changes
Other Study ID Numbers: 95.59.14
Study First Received: September 9, 2008
Last Updated: October 23, 2008
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by St George's Healthcare NHS Trust:
Total hysterectomy
subtotal hysterectomy
urinary function
bowel function
sexual function
Quality of life
Psychological function

ClinicalTrials.gov processed this record on April 17, 2014