Total Versus Subtotal Hysterectomy:a Randomised, Prospective Multicentre Study of the Effect on Urinary, Sexual and Bowel Function
1 other identifier
interventional
279
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 1996
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 1996
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2000
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2000
CompletedFirst Submitted
Initial submission to the registry
September 9, 2008
CompletedFirst Posted
Study publicly available on registry
September 10, 2008
CompletedOctober 24, 2008
September 1, 2008
4.3 years
September 9, 2008
October 23, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Main outcome measure was stress incontinence
Completed
Secondary Outcomes (1)
Quality of life
Completed
Study Arms (2)
1
EXPERIMENTALtotal abdominal hysterectomy and
2
EXPERIMENTALSubtotal hysterectomy
Interventions
Total abdominal hysterectomy and Subtotal abdominal hysterectomy
Eligibility Criteria
You may qualify if:
- Women having abdominal hysterectomy for benign conditions of the uterus
You may not qualify if:
- Suspected cancer
- A body weight that exceeded 100 kg
- Previous pelvic surgery
- Known endometriosis
- Abnormal cervical smears,
- Symptomatic uterine prolapse
- Symptomatic urinary incontinence
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St George's Healthcare NHS Trust
London, SW17 0QT, United Kingdom
Related Publications (3)
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.
PMID: 12397189BACKGROUNDThakar 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.
PMID: 15383114BACKGROUNDThakar 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.
PMID: 19037034DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 9, 2008
First Posted
September 10, 2008
Study Start
January 1, 1996
Primary Completion
April 1, 2000
Study Completion
April 1, 2000
Last Updated
October 24, 2008
Record last verified: 2008-09