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

• Sponsor: St George's Healthcare NHS Trust (Other)
• Overall Status: Completed
• CT.gov ID: NCT00750035
• Collaborator: (none)
• Enrollment: 279
• Location: 1
• Arms: 2
• Duration (Months): 51
• Patients Per Site Per Month: 5.5

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 279 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Jan 1, 1996
• Actual Primary Completion Date: Apr 1, 2000
• Actual Study Completion Date: Apr 1, 2000

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Main outcome measure was stress incontinence [Completed]

Secondary Outcome Measures

1. Quality of life [Completed]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	St George's Healthcare NHS Trust	London		United Kingdom	SW17 0QT

Sponsors and Collaborators

• St George's Healthcare NHS Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

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.

• ClinicalTrials.gov Identifier: NCT00750035
• Other Study ID Numbers: 95.59.14
• First Posted: Sep 10, 2008
• Last Update Posted: Oct 24, 2008
• Last Verified: Sep 1, 2008

• Keywords provided by , ,: Total hysterectomy; subtotal hysterectomy; urinary function; bowel function; sexual function; Quality of life; Psychological function

Study Results

No Results Posted as of Oct 24, 2008