Total Versus Subtotal Hysterectomy:a Randomised, Prospective Multicentre Study of the Effect on Urinary, Sexual and Bowel Function
October 23, 2008 updated by: St George's Healthcare NHS Trust
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
279
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London, United Kingdom, SW17 0QT
- St George's Healthcare NHS Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 1
total abdominal hysterectomy and
|
Total abdominal hysterectomy and Subtotal abdominal hysterectomy
|
|
EXPERIMENTAL: 2
Subtotal hysterectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Main outcome measure was stress incontinence
Time Frame: Completed
|
Completed
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Quality of life
Time Frame: Completed
|
Completed
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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. doi: 10.1056/NEJMoa013336.
- 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. doi: 10.1111/j.1471-0528.2004.00242.x.
- Thakar R, Ayers S, Srivastava R, Manyonda I. Removing the cervix at hysterectomy: an unnecessary intervention? Obstet Gynecol. 2008 Dec;112(6):1262-1269. doi: 10.1097/AOG.0b013e31818f3bf5.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 1996
Primary Completion (ACTUAL)
April 1, 2000
Study Completion (ACTUAL)
April 1, 2000
Study Registration Dates
First Submitted
September 9, 2008
First Submitted That Met QC Criteria
September 9, 2008
First Posted (ESTIMATE)
September 10, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
October 24, 2008
Last Update Submitted That Met QC Criteria
October 23, 2008
Last Verified
September 1, 2008
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 95.59.14
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