HysterectomyNCT00750035
Total Versus Subtotal Hysterectomy:a Randomised, Prospective Multicentre Study of the Effect on Urinary, Sexual and Bowel Function
A study testing Total abdominal hysterectomy and Subtotal abdominal hysterectomy in people with Hysterectomy, run by St George's Healthcare NHS Trust at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- Total abdominal hysterectomy and Subtotal abdominal hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 1996to Apr 2000
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women having abdominal hysterectomy for benign conditions of the uterus
Who cannot join
- Suspected cancer
- A body weight that exceeded 100 kg
- Previous pelvic surgery
- Known endometriosis
- Abnormal cervical smears,
- Symptomatic uterine prolapse
- Symptomatic urinary incontinence
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hysterectomy
- Being tested
- Total abdominal hysterectomy, Subtotal abdominal hysterectomy
- Keywords
- Total hysterectomy, subtotal hysterectomy, urinary function, bowel function, sexual function, Quality of life, Psychological function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total abdominal hysterectomyProcedure or surgery
Total abdominal hysterectomy and Subtotal abdominal hysterectomy
Subtotal abdominal hysterectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | total abdominal hysterectomy and Receives: Procedure: Total abdominal hysterectomy |
| 2 | Experimental | Subtotal hysterectomy Receives: Procedure: Subtotal abdominal hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main outcome measure was stress incontinence
Measured: Completed
Secondary outcomes (1)
Quality of life
Measured: Completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2008 (estimated)
- Study startJan 1996
- Primary completionApr 2000
- Study completionApr 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- St George's Healthcare NHS Trust
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00750035
- Sponsor's protocol ID
- 95.59.14
- Status last verified
- Sep 2008
- First submitted
- 9 Sep 2008
- Last updated
- 24 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 12397189Thakar 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.
PubMed 15383114Thakar 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.
PubMed 19037034
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Versus Subtotal Hysterectomy:a Randomised, Prospective Multicentre Study of the Effect on Urinary, Sexual and Bowel Function
- ClinicalTrials.gov ID
- NCT00750035
- Acronym / sponsor ID
- 95.59.14
- Conditions
- Hysterectomy
- Keywords
- Total hysterectomy, subtotal hysterectomy, urinary function, bowel function, sexual function, Quality of life, Psychological function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- St George's Healthcare NHS TrustUniversity, hospital or other
- Study start
- Jan 1996
- Primary completion
- Apr 2000 (actual)
- Study completion
- Apr 2000 (actual)
- First posted
- 10 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Total abdominal hysterectomytotal abdominal hysterectomy and |
| 2 | Experimental | Procedure: Subtotal abdominal hysterectomySubtotal hysterectomy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Women having abdominal hysterectomy for benign conditions of the uterus
Key exclusion criteria (7 listed)
- Suspected cancer
- A body weight that exceeded 100 kg
- Previous pelvic surgery
- Known endometriosis
- Abnormal cervical smears,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total abdominal hysterectomyTotal abdominal hysterectomy and Subtotal abdominal hysterectomy | Procedure or surgery | 1 |
| Subtotal abdominal hysterectomy | Procedure or surgery | 2 |
Primary outcome
Main outcome measure was stress incontinence
Time frame: Completed
1 secondary outcome
Quality of life
Time frame: Completed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2008.
- Background: PubMed 12397189Thakar 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.
- Background: PubMed 15383114Thakar 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.
- Derived from this study: PubMed 19037034Thakar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total abdominal hysterectomy and Subtotal abdominal hysterectomy in people with Hysterectomy, run by St George's Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main outcome measure was stress incontinence (time frame: Completed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00750035, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2008.