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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00750035
Other study ID # 95.59.14
Secondary ID
Status Completed
Phase N/A
First received September 9, 2008
Last updated October 23, 2008
Start date January 1996
Est. completion date April 2000

Study information

Verified date September 2008
Source St George's Healthcare NHS Trust
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 279
Est. completion date April 2000
Est. primary completion date April 2000
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Total abdominal hysterectomy
Total abdominal hysterectomy and Subtotal abdominal hysterectomy
Subtotal abdominal hysterectomy


Locations

Country Name City State
United Kingdom St George's Healthcare NHS Trust London

Sponsors (1)

Lead Sponsor Collaborator
St George's Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Main outcome measure was stress incontinence Completed No
Secondary Quality of life Completed No
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