Single Incision Laparoscopic Cholecystectomy (SILC)
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|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|
|Actual Primary Completion Date :||December 2009|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|