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Surgical Success After Laparoscopic vs Abdominal Hysterectomy

This study is currently recruiting participants.
Verified February 2013 by University of Texas Southwestern Medical Center
Sponsor:
Information provided by (Responsible Party):
Kinberly Kho, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01793584
First received: February 13, 2013
Last updated: February 27, 2013
Last verified: February 2013
History of Changes
  Purpose

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.

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.


Condition Intervention Phase
Metrorrhagia
Menorrhagia
Leiomyoma
Adenomyosis
Pelvic Pain
Endometriosis
Pelvic Inflammatory Disease
 Procedure: Laparoscopic hysterectomy
Procedure: Abdominal hysterectomy
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Quality of life [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Hospital charges and indirect costs of missed work/caregiving due to hysterectomy will be calculated

  • Complications [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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: June 2015
Estimated Primary Completion Date: June 2015 (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 Procedure: Abdominal hysterectomy

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01793584

Contacts
Contact: Kimberly Kho, MD, MPH 2146486430 kimberly.kho@utsouthwestern.edu
Contact: Joseph Schaffer, MD 2146487211 Joseph.Schaffer@utsouthwestern.edu

Locations
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
Investigators
Principal Investigator: Kimberly Kho, MD, MPH University of Texas Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Kinberly Kho, Assistant Professor, Department of Obstetrics and Gynecology, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01793584     History of Changes
Other Study ID Numbers: STU 032012-067
Study First Received: February 13, 2013
Last Updated: February 27, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Endometriosis
Leiomyoma
Myofibroma
Menorrhagia
Metrorrhagia
Pelvic Pain
Pelvic Inflammatory Disease
Pelvic Infection
Genital Diseases, Female
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
 Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Uterine Hemorrhage
Uterine Diseases
Menstruation Disturbances
Pathologic Processes
Hemorrhage
Pain
Signs and Symptoms
Infection
Adnexal Diseases

ClinicalTrials.gov processed this record on May 23, 2013