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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014