Surgical Success After Laparoscopic vs Abdominal Hysterectomy

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Brief Title

Surgical Success After Laparoscopic vs Abdominal Hysterectomy

Official Title

Randomized Trial of Laparoscopic Versus Abdominal Hysterectomy for Benign Indications and Impact on Surgical Success

Brief Summary

      The purpose of the proposed pilot study is to investigate the effectiveness, cost, safety,
      and long-term impact on quality of life of laparoscopic hysterectomy (LH) in relation to
      abdominal hysterectomy (AH) for the treatment of benign gynecologic disease in women through
      a randomized surgical trial.
    

Detailed Description

      The overall hypothesis is that neither mode of hysterectomy will be consistently superior to
      the other with respect to each of the three domains of complications, cost, and
      patient-centered outcomes. The overall goal of the study is to determine which clinically
      relevant factors may impact the choice of LH compared to AH. The results of the study may be
      useful for clinicians, patients, hospital administrators and health policy makers.
    


Study Type

Interventional


Primary Outcome

Quality of life

Secondary Outcome

 Cost

Condition

Metrorrhagia

Intervention

Laparoscopic hysterectomy

Study Arms / Comparison Groups

 Laparoscopic hysterectomy
Description:  Total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

100

Start Date

February 2013

Completion Date

December 31, 2016

Primary Completion Date

December 31, 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Women undergoing hysterectomy for benign indications within 8 weeks of enrollment

          -  Women >18 years of age

          -  Non-emergent surgery

          -  Non-pregnant

        Exclusion Criteria:

          -  Candidate for vaginal hysterectomy

          -  Uterine size >14 weeks by clinical exam OR >300 mL by ultrasound measurement

          -  History of cancer of reproductive tract

          -  Requires concomitant pelvic organ prolapse (POP) surgery

          -  Requires surgery for urinary incontinence

          -  Has acute angle glaucoma

          -  Has severe cardiac/respiratory disease

          -  Desires supracervical hysterectomy
      

Gender

Female

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Kimberly Kho, MD, MPH, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01793584

Organization ID

STU 032012-067


Responsible Party

Principal Investigator

Study Sponsor

University of Texas Southwestern Medical Center


Study Sponsor

Kimberly Kho, MD, MPH, Principal Investigator, University of Texas Southwestern Medical Center


Verification Date

October 2017