Adenomyosis, Endometriosis, Leiomyoma, Menorrhagia, Metrorrhagia, Pelvic Inflammatory Disease, Pelvic Pain
Conditions
Keywords
Comparative effectiveness, Surgical success
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.
Interventions
PROCEDURELaparoscopic hysterectomy
LAVH, TLH
PROCEDUREAbdominal hysterectomy
TAH
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 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
| Measure | Time frame | Description |
|---|---|---|
| Cost | 1 year | Hospital charges and indirect costs of missed work/caregiving due to hysterectomy will be calculated |
| Complications | 1 year | Intraoperative and postoperative complications including conversions, unintentional lacerations/injury to organs, hemorrhage, infection, wound complications, VTE, death, pain, neuropathy |
Countries
United States
Outcome results
None listed