Laparoscopic Supracervical Hysterectomy Versus Total Laparoscopic Hysterectomy
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.
|Gynecologic Diseases||Procedure: Laparoscopic supracervical hysterectomy Procedure: Total laparoscopic hysterectomy||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Official Title:||LSH vs. TLH, A Randomized Single Blind Trial|
- Return to normal activities [ Time Frame: 3-6 weeks after surgery ]
- Sexual function [ Time Frame: 6 months after surgery ]
|Study Start Date:||May 2008|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: 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|