Clinical Trial: Surgical Success After Laparoscopic vs Abdominal Hysterectomy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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 Summary: 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.
Sponsor: University of Texas Southwestern Medical Center

Current Primary Outcome: Quality of life [ Time Frame: 1 year ]

1) Patient-centered outcomes composite

  1. Quality of life - measured using the Short Form 12 (SF-12v2),
  2. Sexual functioning - measured using the Sexual Activity Questionnaire (SAQ)
  3. Body image - measured using the Body Image Scale (BIS)
  4. Return to normal activity -measured using the Activities Assessment Scale (AAS)
  5. Pain - measured using a 10 point likert scale
  6. Productivity - measured using a questionnaire about missed work


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Cost [ Time Frame: 1 year ]
    Hospital charges and indirect costs of missed work/caregiving due to hysterectomy will be calculated
  • Complications [ Time Frame: 1 year ]
    Intraoperative and postoperative complications including conversions, unintentional lacerations/injury to organs, hemorrhage, infection, wound complications, VTE, death, pain, neuropathy


Original Secondary Outcome: Same as current

Information By: University of Texas Southwestern Medical Center

Dates:
Date Received: February 13, 2013
Date Started: February 2013
Date Completion: December 2016
Last Updated: May 24, 2016
Last Verified: May 2016