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
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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

Locations
United States, Texas
UT Southwestern
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Homero Rivas, MD UTSouthwestern
  More Information

No publications provided

Responsible Party: Homero Rivas, UT Southwestern
ClinicalTrials.gov Identifier: NCT00678873     History of Changes
Other Study ID Numbers: 8843
Study First Received: May 14, 2008
Last Updated: December 14, 2009
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on April 17, 2014