Surgical Success After Laparoscopic vs Abdominal Hysterectomy

Study ID
STU 032012-067

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • Parkland Health & Hospital System

Contact


Principal Investigator

Official Title

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

Brief Overview


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.

Summary


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.

Participant Eligibility


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