Single Incision Laparoscopic Cholecystectomy - Full Text View

Sponsor:	University of Texas Southwestern Medical Center
Information provided by:	North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier:	NCT00678873

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 I

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Single Incision Laparoscopic Cholecystectomy

Resource links provided by NLM:

MedlinePlus related topics: Gallstones Surgery

U.S. FDA Resources

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
Surgical group: Experimental 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.

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

Keywords provided by North Texas Veterans Healthcare System:

Single Incision
Single Access
Surgery
Cholecystectomy

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Gallbladder Diseases
Cholecystolithiasis
Digestive System Diseases

Cholelithiasis
Gallstones
Biliary Tract Diseases
Calculi

ClinicalTrials.gov processed this record on February 08, 2010