Single Incision Laparoscopic Cholecystectomy (SILC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00678873
Recruitment Status : Completed
First Posted : May 16, 2008
Last Update Posted : December 15, 2009
Information provided by:
North Texas Veterans Healthcare System

Brief 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.

Condition or disease Intervention/treatment Phase
Cholelithiasis Procedure: Single Incision Laparoscopic Cholecystectomy Phase 1

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).

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Single Incision Laparoscopic Cholecystectomy
Study Start Date : March 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones

Arm Intervention/treatment
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 access laparoscopic cholecystectomy
  • Cholecystectomy

Primary Outcome Measures :
  1. Safety and feasibility [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Short-term clinical outcomes [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00678873

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

Responsible Party: Homero Rivas, UT Southwestern Identifier: NCT00678873     History of Changes
Other Study ID Numbers: 8843
First Posted: May 16, 2008    Key Record Dates
Last Update Posted: December 15, 2009
Last Verified: August 2008

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

Additional relevant MeSH terms:
Surgical Wound
Wounds and Injuries
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical