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Single Incision Laparoscopic Cholecystectomy (SILC)
This study is currently recruiting participants.
Verified by North Texas Veterans' Healthcare System, August 2008
First Received: May 14, 2008   Last Updated: September 12, 2008   History of Changes
Sponsored by: University of Texas Southwestern Medical Center
Information provided by: North Texas Veterans' Healthcare System
ClinicalTrials.gov Identifier: NCT00678873
  Purpose

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 Intervention Phase
Cholelithiasis
Procedure: Single Incision Laparoscopic Cholecystectomy
Phase I

Study Type: Interventional
Study Design: Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Single Incision Laparoscopic Cholecystectomy

Resource links provided by NLM:


Further study details as provided by North Texas Veterans' Healthcare System:

Primary Outcome Measures:
  • Safety and feasibility [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Short-term clinical outcomes [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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.

Detailed Description:

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
Criteria

Inclusion Criteria:

  • Adults male and female(>18 years old)
  • Capable of giving informed consent
  • Ultrasound proven cholelithiasis
  • Symptomatic cholelithiasis
  • Elective cholecystectomy

Exclusion Criteria:

  • Pregnancy
  • Contraindications for general anesthesia
  • Morbid obesity
  • Multiple previous abdominal surgeries
  • Uncontrolled medical conditions
  • Acute cholecystitis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00678873

Contacts
Contact: Homero Rivas, MD 214-645-8190 homero.rivas@utsouthwestern.edu
Contact: Daniel Scott, MD

Locations
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            
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Homero Rivas, MD UTSouthwestern
Principal Investigator: Daniel Scott, MD UT Southwestern
Principal Investigator: Esteban Varela, MD, MPH UT Southwestern
  More Information

Additional Information:
No publications provided

Responsible Party: UT Southwestern ( Homero Rivas and Daniel Scott )
Study ID Numbers: 8843
Study First Received: May 14, 2008
Last Updated: September 12, 2008
ClinicalTrials.gov Identifier: NCT00678873     History of Changes
Health Authority: United States: Federal Government

Keywords provided by North Texas Veterans' Healthcare System:
Single Incision
Single Access
Surgery
Cholecystectomy

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Gallbladder Diseases
Cholecystolithiasis
Digestive System Diseases
Cholelithiasis
Gallstones
Biliary Tract Diseases
Anesthetics
Calculi

Additional relevant MeSH terms:
Pathological Conditions, Anatomical
Gallbladder Diseases
Cholecystolithiasis
Digestive System Diseases
Cholelithiasis
Gallstones
Biliary Tract Diseases
Calculi

ClinicalTrials.gov processed this record on July 06, 2009