Randomized Trial of Laparoscopic Versus Abdominal Hysterectomy for Benign Indications and Impact on Surgical Success
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Quality of life
Study Overview
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Laparoscopic hysterectomy
Total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy
Intervention: Laparoscopic hysterectomy (Procedure)
Abdominal hysterectomy
Total Abdominal Hysterectomy
Intervention: Abdominal hysterectomy (Procedure)
Outcomes
Primary Outcomes
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 Outcomes
- Cost(1 year)
- Complications(1 year)
Investigators
Kinberly Kho
Associate Professor, Department of Obstetrics and Gynecology
University of Texas Southwestern Medical Center