NCT00734812

Laparoscopic Supracervical Hysterectomy Versus Total Laparoscopic Hysterectomy

LSH vs. TLH, A Randomized Single Blind Trial

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Gynecologic Diseases

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic supracervical hysterectomy	Patients will be randomized to LSH (retaining the cervix) and TLH (cervix removal)
PROCEDURE	Total laparoscopic hysterectomy	Patients will be randomized to either removal or retention of cervix

Timeline

• Start date: 2008-05-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2008-08-14
• Last updated: 2013-01-24

Locations

1 site across 1 country: United States