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

History of Changes

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:

MedlinePlus related topics: Bowel Movement Hysterectomy

U.S. FDA Resources

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:

Thakar R, Ayers S, Clarkson P, Stanton S, Manyonda I. Outcomes after total versus subtotal abdominal hysterectomy. N Engl J Med. 2002 Oct 24;347(17):1318-25.

Thakar R, Ayers S, Georgakapolou A, Clarkson P, Stanton S, Manyonda I. Hysterectomy improves quality of life and decreases psychiatric symptoms: a prospective and randomised comparison of total versus subtotal hysterectomy. BJOG. 2004 Oct;111(10):1115-20.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Thakar R, Ayers S, Srivastava R, Manyonda I. Removing the cervix at hysterectomy: an unnecessary intervention? Obstet Gynecol. 2008 Dec;112(6):1262-9.

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 May 16, 2013

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