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Surgical Success After Laparoscopic vs Abdominal Hysterectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01793584
First Posted: February 15, 2013
Last Update Posted: October 26, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kinberly Kho, University of Texas Southwestern Medical Center
  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.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Kinberly Kho, 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


Enrollment: 100
Study Start Date: February 2013
Study Completion Date: December 31, 2016
Primary Completion Date: December 31, 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
LAVH, TLH
Active Comparator: Abdominal hysterectomy
Total Abdominal Hysterectomy
Procedure: Abdominal hysterectomy
TAH

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01793584


Locations
United States, Texas
Parkland Hospital
Dallas, Texas, United States, 75235
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Kimberly Kho, MD, MPH University of Texas Southwestern Medical Center
  More Information

Responsible Party: Kinberly Kho, Associate 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
First Submitted: February 13, 2013
First Posted: February 15, 2013
Last Update Posted: October 26, 2017
Last Verified: October 2017

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

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