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Laparoscopic Supracervical Hysterectomy Versus Total Laparoscopic Hysterectomy

This study has been withdrawn prior to enrollment.
(Study was withdrawn prior to any enrollment.)
Sponsor:
Information provided by (Responsible Party):
Jon I. Einarsson, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00734812
First received: August 12, 2008
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: LSH vs. TLH, A Randomized Single Blind Trial

Resource links provided by NLM:

MedlinePlus related topics: Hysterectomy
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 ]

Enrollment: 0
Study Start Date: May 2008
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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
Boston, Massachusetts, United States, 02115
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: 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
Study First Received: August 12, 2008
Last Updated: January 23, 2013
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 May 21, 2013