NCT01793584

Surgical Success After Laparoscopic vs Abdominal Hysterectomy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Conditions

• Metrorrhagia
• Menorrhagia
• Leiomyoma
• Adenomyosis
• Pelvic Pain
• Endometriosis
• Pelvic Inflammatory Disease

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic hysterectomy	LAVH, TLH
PROCEDURE	Abdominal hysterectomy	TAH

Timeline

• Start date: 2013-02-01
• Primary completion: 2016-12-31
• Completion: 2016-12-31
• First posted: 2013-02-15
• Last updated: 2017-10-26

Locations

1 site across 1 country: United States