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

Hysterectomy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00750035
• Other study ID #: 95.59.14
• 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

• Hysterectomy

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