Laparoscopic Supracervical Hysterectomy Versus Total Laparoscopic Hysterectomy

Phase 3

Withdrawn

• Conditions: Gynecologic Diseases
• Interventions: Procedure: Total laparoscopic hysterectomy; Procedure: Laparoscopic supracervical hysterectomy

• Registration Number: NCT00734812
• Lead Sponsor: Brigham and Women's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-08-12
• Study First Submitted QC: 2008-08-13
• Study First Posted: 2008-08-14
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-23
• Last Update Posted: 2013-01-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Total laparoscopic hysterectomy	Total Laparoscopic Hysterectomy (TLH)
1	Laparoscopic supracervical hysterectomy	Laparoscopic supracervical hysterectomy (LSH)

Primary Outcome Measures

Name	Time	Method
Return to normal activities	3-6 weeks after surgery

Secondary Outcome Measures

Name	Time	Method
Sexual function	6 months after surgery

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States