Laparoscopic Supracervical Hysterectomy Versus Total Laparoscopic Hysterectomy
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|ClinicalTrials.gov Identifier: NCT00734812|
Recruitment Status : Withdrawn (Study was withdrawn prior to any enrollment.)
First Posted : August 14, 2008
Last Update Posted : January 24, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Gynecologic Diseases||Procedure: Laparoscopic supracervical hysterectomy Procedure: Total laparoscopic hysterectomy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||LSH vs. TLH, A Randomized Single Blind Trial|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
Active Comparator: 1
Laparoscopic supracervical hysterectomy (LSH)
Procedure: Laparoscopic supracervical hysterectomy
Patients will be randomized to LSH (retaining the cervix) and TLH (cervix removal)
Active Comparator: 2
Total Laparoscopic Hysterectomy (TLH)
Procedure: Total laparoscopic hysterectomy
Patients will be randomized to either removal or retention of cervix
- Return to normal activities [ Time Frame: 3-6 weeks after surgery ]
- Sexual function [ Time Frame: 6 months after surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00734812
|United States, Massachusetts|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Jon I. Einarsson, MD||Brigham and Women's Hospital|