Single Incision Laparoscopic Cholecystectomy (SILC)
|ClinicalTrials.gov Identifier: NCT00678873|
Recruitment Status : Completed
First Posted : May 16, 2008
Last Update Posted : December 15, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Cholelithiasis||Procedure: Single Incision Laparoscopic Cholecystectomy||Phase 1|
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Single Incision Laparoscopic Cholecystectomy|
|Study Start Date :||March 2008|
|Primary Completion Date :||December 2009|
|Study Completion Date :||December 2009|
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.
- Safety and feasibility [ Time Frame: 12 months ]
- Short-term clinical outcomes [ Time Frame: 12 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00678873
|United States, Texas|
|Dallas, Texas, United States, 75390|
|Principal Investigator:||Homero Rivas, MD||UTSouthwestern|