Laparoscopic Supracervical Hysterectomy (LSH) Versus Total Laparoscopic Hysterectomy (TLH), A Randomized Single Blind Trial - Full Text View

Sponsor:	Brigham and Women's Hospital
Information provided by:	Brigham and Women's Hospital
ClinicalTrials.gov Identifier:	NCT00734812

Purpose

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	Intervention	Phase
Gynecologic Diseases	Procedure: Laparoscopic supracervical hysterectomy Procedure: Total laparoscopic hysterectomy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Parallel Assignment
Official Title:	LSH vs. TLH, A Randomized Single Blind Trial

Resource links provided by NLM:

MedlinePlus related topics: Hysterectomy Reproductive Health Surgery

U.S. FDA Resources

Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:

Return to normal activities [ Time Frame: 3-6 weeks after surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Sexual function [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]

Estimated Enrollment:	172
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Laparoscopic supracervical hysterectomy (LSH)	Procedure: Laparoscopic supracervical hysterectomy Patients will be randomized to LSH (retaining the cervix) and TLH (cervix removal)
2: Active Comparator Total Laparoscopic Hysterectomy (TLH)	Procedure: Total laparoscopic hysterectomy

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00734812

Locations

United States, Massachusetts
Brigham and Women's Hospital	Recruiting
Boston, Massachusetts, United States, 02115
Contact: Jon I Einarsson, MD 617-525-8582 jeinarsson@partners.org
Principal Investigator: Jon I Einarsson, MD MPH

Sponsors and Collaborators

Brigham and Women's Hospital

Investigators

Principal Investigator:

Jon I. Einarsson, MD

Brigham and Women's Hospital

More Information

No publications provided

Responsible Party:	Brigham and Women's Hospital ( Jon Einarsson MD MPH )
Study ID Numbers:	2007-P-002591/1
Study First Received:	August 12, 2008
Last Updated:	September 15, 2009
ClinicalTrials.gov Identifier:	NCT00734812 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:

Hysterectomy
Laparoscopic

Additional relevant MeSH terms:

Genital Diseases, Female

ClinicalTrials.gov processed this record on February 08, 2010