Single Incision Laparoscopic Cholecystectomy

Cholelithiasis Clinical Trial

— SILC  

Official title:

Single Incision Laparoscopic Cholecystectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00678873
• Other study ID #: 8843
• Status: Completed
• Phase: Phase 1
• First received: May 14, 2008
• Last updated: December 14, 2009
• Start date: March 2008
• Est. completion date: December 2009

Study information

• Verified date: August 2008
• Source: North Texas Veterans Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Procedure:
• Single Incision Laparoscopic Cholecystectomy
A single trans-umbilical incision laparoscopic cholecystectomy will be performed by standard fashion and under general anesthesia.

Locations

Country	Name	City	State
United States	UT Southwestern	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and feasibility		12 months	Yes
Secondary	Short-term clinical outcomes		12 months	No