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| Sponsors and Collaborators: |
University of Texas Southwestern Medical Center North Texas Veterans' Healthcare System |
| Information provided by: | North Texas Veterans' Healthcare System |
| ClinicalTrials.gov Identifier: | NCT00678873 |
Purpose
We aim to investigate the safety, feasibility and short-term outcomes of Single Incision Laparoscopic Cholecystectomy.
We hypothesize that Single Incision Laparoscopic Cholecystectomy is safe and feasible.
| Condition | Intervention | Phase |
|
Cholelithiasis |
Procedure: Single Incision Laparoscopic Cholecystectomy |
Phase I |
| MedlinePlus related topics: | Gallstones |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Single Incision Laparoscopic Cholecystectomy |
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2008 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|
Surgical group: Experimental
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.
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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).
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Homero Rivas, MD | 214-645-8190 | homero.rivas@utsouthwestern.edu |
| Contact: Esteban Varela, MD, MPH | 214-857-1800 | esteban.varela@utsouthwestern.edu |
| United States, Texas | |||||
| UT Southwestern | Recruiting | ||||
| Dallas, Texas, United States, 75390 | |||||
| Contact: Homero Rivas, MD 214-645-8190 homero.rivas@utsouthwestern.edu | |||||
| Principal Investigator: Esteban Varela, MD, MPH | |||||
| University of Texas Southwestern Medical Center |
| North Texas Veterans' Healthcare System |
| Principal Investigator: | Homero Rivas, MD | UTSouthwestern |
| Principal Investigator: | Daniel Scott, MD | UT Southwestern |
| Principal Investigator: | Esteban Varela, MD, MPH | UT Southwestern and VA North Texas |
More Information
Surgeons complete North Texas' first single-incision gallbladder removal 
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| Responsible Party: | UT Southwestern ( Homero Rivas ) |
| Study ID Numbers: | 8843 |
| First Received: | May 14, 2008 |
| Last Updated: | August 25, 2008 |
| ClinicalTrials.gov Identifier: | NCT00678873 |
| Health Authority: | United States: Federal Government |
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