Single Incision Laparoscopic Cholecystectomy (SILC)
The investigators aim to investigate the safety, feasibility and short-term outcomes of Single Incision Laparoscopic Cholecystectomy.
The investigators hypothesize that Single Incision Laparoscopic Cholecystectomy is safe and feasible.
|Cholelithiasis||Procedure: Single Incision Laparoscopic Cholecystectomy||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Single Incision Laparoscopic Cholecystectomy|
- Safety and feasibility [ Time Frame: 12 months ]
- Short-term clinical outcomes [ Time Frame: 12 months ]
|Study Start Date:||March 2008|
|Study Completion Date:||December 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Experimental: Surgical group
Patients with ultrasound proven symptomatic cholelithiasis (gallstones).
Procedure: Single Incision Laparoscopic Cholecystectomy
A single trans-umbilical incision laparoscopic cholecystectomy will be performed by standard fashion and under general anesthesia.
Laparoscopic cholecystectomy is the standard approach for the treatment of gallbladder disease. Laparoscopic cholecystectomy is now performed as an outpatient procedure and it commonly requires the use of 4 separate small incisions. Single incision or single access trans-umbilical surgery may provide less pain, scarring and may improve patient's overall satisfaction.
In this phase I trial we aim to evaluate the safety, feasibility and short-term outcomes of Single Incision Laparoscopic Cholecystectomy for the treatment of symptomatic cholelithiasis (gallstones).
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678873
|United States, Texas|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Homero Rivas, MD||UTSouthwestern|