Laparoscopic Supracervical Hysterectomy Versus Total Laparoscopic Hysterectomy
NCT ID: NCT00734812
Last Updated: 2013-01-24
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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WITHDRAWN
PHASE3
INTERVENTIONAL
2008-05-31
2012-01-31
Brief Summary
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Patients will be assigned by chance (like a coin toss) to have either a LSH or a TLH. Preoperatively, participants will complete a quality of life questionnaire (SF-36), a sexual function questionnaire (FSFI)and a 3 question questionnaire about urinary function (3IQ).
Following surgery participants will be asked to keep a diary of pain symptoms and use of narcotics. The diary will be filled out daily until patients have resumed normal activities from prior to the surgery. The SF-36 will be completed again 6 weeks following the original surgery.
6 months following surgery participants will receive a copy of the SF-36 and the FSFI in the mail. They will also be asked questions about urinary symptoms and persistent vaginal bleeding.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Laparoscopic supracervical hysterectomy (LSH)
Laparoscopic supracervical hysterectomy
Patients will be randomized to LSH (retaining the cervix) and TLH (cervix removal)
2
Total Laparoscopic Hysterectomy (TLH)
Total laparoscopic hysterectomy
Patients will be randomized to either removal or retention of cervix
Interventions
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Laparoscopic supracervical hysterectomy
Patients will be randomized to LSH (retaining the cervix) and TLH (cervix removal)
Total laparoscopic hysterectomy
Patients will be randomized to either removal or retention of cervix
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* pre-malignant changes of the uterus, cervix or adnexa
* history of severe cervical dysplasia (CIN II or above)
18 Years
FEMALE
Yes
Sponsors
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Brigham and Women's Hospital
OTHER
Responsible Party
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Jon I. Einarsson
Chief, Division of Minimally Invasive Gynecology
Principal Investigators
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Jon I. Einarsson, MD
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Countries
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Other Identifiers
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2007-P-002591/1
Identifier Type: -
Identifier Source: org_study_id
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