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Surgical Success After Laparoscopic vs Abdominal Hysterectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2016 by University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
Kinberly Kho, University of Texas Southwestern Medical Center Identifier:
First received: February 13, 2013
Last updated: May 24, 2016
Last verified: May 2016
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.

Condition Intervention Phase
Pelvic Pain
Pelvic Inflammatory Disease
Procedure: Laparoscopic hysterectomy
Procedure: Abdominal hysterectomy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Randomized Trial of Laparoscopic Versus Abdominal Hysterectomy for Benign Indications and Impact on Surgical Success

Resource links provided by NLM:

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • 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

Secondary Outcome 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

Estimated Enrollment: 75
Study Start Date: February 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Laparoscopic hysterectomy
Total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy
Procedure: Laparoscopic hysterectomy
Active Comparator: Abdominal hysterectomy
Total Abdominal Hysterectomy
Procedure: Abdominal hysterectomy

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.

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  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 identifier: NCT01793584

Contact: Kimberly Kho, MD, MPH 2146486430
Contact: Joseph Schaffer, MD 2146487211

United States, Texas
Parkland Hospital Recruiting
Dallas, Texas, United States, 75235
Contact: Kimberly Kho, MD, MPH    214-648-6430      
Principal Investigator: Kimberly Kho, MD, MPH         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Principal Investigator: Kimberly Kho, MD, MPH University of Texas Southwestern Medical Center
  More Information

Responsible Party: Kinberly Kho, Assistant Professor, Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center Identifier: NCT01793584     History of Changes
Other Study ID Numbers: STU 032012-067
Study First Received: February 13, 2013
Last Updated: May 24, 2016

Keywords provided by University of Texas Southwestern Medical Center:
Comparative effectiveness
Surgical success

Additional relevant MeSH terms:
Pelvic Pain
Pelvic Inflammatory Disease
Pelvic Infection
Genital Diseases, Female
Neurologic Manifestations
Signs and Symptoms
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Uterine Hemorrhage
Uterine Diseases
Menstruation Disturbances
Pathologic Processes
Adnexal Diseases processed this record on April 28, 2017