Single Incision Laparoscopic Cholecystectomy (SILC)

This study has been completed.
Sponsor:
Information provided by:
North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT00678873
First received: May 14, 2008
Last updated: December 14, 2009
Last verified: August 2008

May 14, 2008
December 14, 2009
March 2008
December 2009   (final data collection date for primary outcome measure)
Safety and feasibility [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00678873 on ClinicalTrials.gov Archive Site
Short-term clinical outcomes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Single Incision Laparoscopic Cholecystectomy
Single Incision Laparoscopic Cholecystectomy

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.

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).

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Cholelithiasis
Procedure: Single Incision Laparoscopic Cholecystectomy
A single trans-umbilical incision laparoscopic cholecystectomy will be performed by standard fashion and under general anesthesia.
Other Names:
  • Single incision surgery
  • Single access surgery
  • Single incision laparoscopy
  • Single access laparoscopy
  • Laparoscopic cholecystectomy
  • Single incision laparoscopic cholecystectomy
  • Single access laparoscopic cholecystectomy
  • Cholecystectomy
Experimental: Surgical group
Patients with ultrasound proven symptomatic cholelithiasis (gallstones).
Intervention: Procedure: Single Incision Laparoscopic Cholecystectomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00678873
8843
No
Homero Rivas, UT Southwestern
University of Texas Southwestern Medical Center
Not Provided
Principal Investigator: Homero Rivas, MD UTSouthwestern
North Texas Veterans Healthcare System
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP