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

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ClinicalTrials.gov Identifier: NCT00750035
Recruitment Status : Completed
First Posted : September 10, 2008
Last Update Posted : October 24, 2008
Sponsor:
Information provided by:
St George's Healthcare NHS Trust

Brief Summary:

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 or disease Intervention/treatment Phase
Hysterectomy Procedure: Total abdominal hysterectomy Procedure: Subtotal abdominal hysterectomy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 279 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : January 1996
Actual Primary Completion Date : April 2000
Actual Study Completion Date : April 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Main outcome measure was stress incontinence [ Time Frame: Completed ]

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: Completed ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00750035


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

Publications:
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
First Posted: September 10, 2008    Key Record Dates
Last Update Posted: October 24, 2008
Last Verified: September 2008

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