Total Versus Subtotal Hysterectomy:a Randomised, Prospective Multicentre Study of the Effect on Urinary, Sexual and Bowel Function
NCT ID: NCT00750035
Last Updated: 2008-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
279 participants
INTERVENTIONAL
1996-01-31
2000-04-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
total abdominal hysterectomy and
Total abdominal hysterectomy
Total abdominal hysterectomy and Subtotal abdominal hysterectomy
2
Subtotal hysterectomy
Subtotal abdominal hysterectomy
Interventions
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Total abdominal hysterectomy
Total abdominal hysterectomy and Subtotal abdominal hysterectomy
Subtotal abdominal hysterectomy
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* A body weight that exceeded 100 kg
* Previous pelvic surgery
* Known endometriosis
* Abnormal cervical smears,
* Symptomatic uterine prolapse
* Symptomatic urinary incontinence
18 Years
60 Years
FEMALE
No
Sponsors
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St George's Healthcare NHS Trust
OTHER
Responsible Party
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St George's Healthcare NHS Trust
Locations
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St George's Healthcare NHS Trust
London, , United Kingdom
Countries
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References
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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.
Other Identifiers
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95.59.14
Identifier Type: -
Identifier Source: org_study_id