Surgical Success After Laparoscopic vs Abdominal Hysterectomy



Status:Completed
Conditions:Women's Studies, Endometriosis
Therapuetic Areas:Other, Reproductive
Healthy:No
Age Range:18 - 80
Updated:10/28/2017
Start Date:February 2013
End Date:December 31, 2016

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Randomized Trial of Laparoscopic Versus Abdominal Hysterectomy for Benign Indications and Impact on Surgical Success

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.

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
We found this trial at
1
site
Dallas, Texas 75390
Principal Investigator: Kimberly Kho, MD, MPH
Phone: 214-648-6430
?
mi
from
Dallas, TX
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