Gynecologic Diseases Clinical Trial
Official title:
LSH vs. TLH, A Randomized Single Blind Trial
Verified date | January 2013 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The purpose of this research study is to evaluate whether there is any difference in
recovery time and return to normal activities following a laparoscopic supracervical
hysterectomy (LSH) compared with total laparoscopic hysterectomy (TLH). Both types of
hysterectomies are commonly performed at our institution.
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 2012 |
Est. primary completion date | January 2012 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Candidates for laparoscopic hysterectomy for benign indications Exclusion Criteria: - Malignancy of the uterus, cervix or adnexa - pre-malignant changes of the uterus, cervix or adnexa - history of severe cervical dysplasia (CIN II or above) |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Return to normal activities | 3-6 weeks after surgery | No | |
Secondary | Sexual function | 6 months after surgery | No |
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