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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic hysterectomy | Active Comparator | Total laparoscopic hysterectomy, laparoscopic assisted vaginal hysterectomy |
|
| Abdominal hysterectomy | Active Comparator | Total Abdominal Hysterectomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic hysterectomy | Procedure | LAVH, TLH |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life | 1) Patient-centered outcomes composite
| 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Cost | Hospital charges and indirect costs of missed work/caregiving due to hysterectomy will be calculated | 1 year |
| Complications | Intraoperative and postoperative complications including conversions, unintentional lacerations/injury to organs, hemorrhage, infection, wound complications, VTE, death, pain, neuropathy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kimberly Kho, MD, MPH | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Parkland Hospital | Dallas | Texas | 75235 | United States |
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| ID | Term |
|---|---|
| D008796 | Metrorrhagia |
| D008595 | Menorrhagia |
| D007889 | Leiomyoma |
| D062788 | Adenomyosis |
| D017699 | Pelvic Pain |
| D004715 | Endometriosis |
| D000292 | Pelvic Inflammatory Disease |
| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
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| Abdominal hysterectomy |
| Procedure |
TAH |
|
| 1 year |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008599 | Menstruation Disturbances |
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D034161 | Pelvic Infection |
| D007239 | Infections |
| D000291 | Adnexal Diseases |