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Laparoscopic Supracervical Hysterectomy Versus Total Laparoscopic Hysterectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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Recruitment Status : Withdrawn (Study was withdrawn prior to any enrollment.)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
Information provided by (Responsible Party):
Jon I. Einarsson, 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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: LSH vs. TLH, A Randomized Single Blind Trial
Study Start Date : May 2008
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Return to normal activities [ Time Frame: 3-6 weeks after surgery ]

Secondary Outcome Measures :
  1. Sexual function [ Time Frame: 6 months after surgery ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

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
Sponsors and Collaborators
Brigham and Women's Hospital
Principal Investigator: Jon I. Einarsson, MD Brigham and Women's Hospital

Responsible Party: Jon I. Einarsson, Chief, Division of Minimally Invasive Gynecology, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00734812     History of Changes
Other Study ID Numbers: 2007-P-002591/1
First Posted: August 14, 2008    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: January 2013

Keywords provided by Jon I. Einarsson, Brigham and Women's Hospital:

Additional relevant MeSH terms:
Genital Diseases, Female