Surgical Success After Laparoscopic vs Abdominal Hysterectomy

Overview

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.

Full Title of Study: “Randomized Trial of Laparoscopic Versus Abdominal Hysterectomy for Benign Indications and Impact on Surgical Success”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2016

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.

Interventions

  • Procedure: Laparoscopic hysterectomy
    • LAVH, TLH
  • Procedure: Abdominal hysterectomy
    • TAH

Arms, Groups and Cohorts

  • Active Comparator: Laparoscopic hysterectomy
    • Total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy
  • Active Comparator: Abdominal hysterectomy
    • Total Abdominal Hysterectomy

Clinical Trial Outcome Measures

Primary Measures

  • Quality of life
    • Time Frame: 1 year
    • 1) Patient-centered outcomes composite Quality of life – measured using the Short Form 12 (SF-12v2), Sexual functioning – measured using the Sexual Activity Questionnaire (SAQ) Body image – measured using the Body Image Scale (BIS) Return to normal activity -measured using the Activities Assessment Scale (AAS) Pain – measured using a 10 point likert scale Productivity – measured using a questionnaire about missed work

Secondary Measures

  • 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

Participating in This Clinical Trial

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 Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Texas Southwestern Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Kinberly Kho, Associate Professor, Department of Obstetrics and Gynecology – University of Texas Southwestern Medical Center
  • Overall Official(s)
    • Kimberly Kho, MD, MPH, Principal Investigator, University of Texas Southwestern Medical Center

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