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Study was withdrawn prior to any enrollment.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Laparoscopic supracervical hysterectomy (LSH) |
|
| 2 | Active Comparator | Total Laparoscopic Hysterectomy (TLH) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic supracervical hysterectomy | Procedure | Patients will be randomized to LSH (retaining the cervix) and TLH (cervix removal) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Return to normal activities | 3-6 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Sexual function | 6 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon I. Einarsson, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| Total laparoscopic hysterectomy | Procedure | Patients will be randomized to either removal or retention of cervix |
|