Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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This study has been withdrawn prior to enrollment.
(Study was withdrawn prior to any enrollment.)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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 20, 2014