An interventional study of Laparoscopic hysterectomy and Abdominal hysterectomy in Metrorrhagia, Menorrhagia and Leiomyoma, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-26.
Sponsored by University of Texas Southwestern Medical Center · Not applicable, Interventional, and Health services research
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.
37 studies on the registry are indexed under Pelvic Inflammatory Disease; 5 are open to participants now.
This study's enrollment of 100 is below the median of 163 across 30 interventional studies indexed under Pelvic Inflammatory Disease.
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Exclusion Criteria:
Total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy
Procedure: Laparoscopic hysterectomy
Total Abdominal Hysterectomy
Procedure: Abdominal hysterectomy
LAVH, TLH
TAH
Quality of life
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
Time frame: 1 year
Cost
Hospital charges and indirect costs of missed work/caregiving due to hysterectomy will be calculated
Time frame: 1 year
Complications
Intraoperative and postoperative complications including conversions, unintentional lacerations/injury to organs, hemorrhage, infection, wound complications, VTE, death, pain, neuropathy
Time frame: 1 year
This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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University of Texas Southwestern Medical Center