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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Cholecystolithiasis
Cholelithiasis
Gallstones
Biliary Tract Diseases
Calculi
Digestive System Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 20, 2014