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Single Incision Laparoscopic Cholecystectomy (SILC)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00678873
First Posted: May 16, 2008
Last Update Posted: December 15, 2009
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.
Information provided by:
North Texas Veterans Healthcare System
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]

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

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 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Homero Rivas, UT Southwestern
ClinicalTrials.gov Identifier: NCT00678873     History of Changes
Other Study ID Numbers: 8843
First Submitted: May 14, 2008
First Posted: May 16, 2008
Last Update Posted: December 15, 2009
Last Verified: August 2008

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

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