Single Incision Laparoscopic Cholecystectomy - Full Text View

Purpose

We aim to investigate the safety, feasibility and short-term outcomes of Single Incision Laparoscopic Cholecystectomy.

We hypothesize that Single Incision Laparoscopic Cholecystectomy is safe and feasible.

Condition	Intervention	Phase
Cholelithiasis	Procedure: Single Incision Laparoscopic Cholecystectomy	Phase I

MedlinePlus related topics:

Gallstones

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	Single Incision Laparoscopic Cholecystectomy

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
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 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

Contacts


Contact: Homero Rivas, MD	214-645-8190	homero.rivas@utsouthwestern.edu

Contact: Esteban Varela, MD, MPH	214-857-1800	esteban.varela@utsouthwestern.edu

Locations


United States, Texas
	UT Southwestern	Recruiting
	Dallas, Texas, United States, 75390
	Contact: Homero Rivas, MD 214-645-8190 homero.rivas@utsouthwestern.edu
	Principal Investigator: Esteban Varela, MD, MPH

Sponsors and Collaborators

University of Texas Southwestern Medical Center

North Texas Veterans' Healthcare System

Investigators


Principal Investigator:	Homero Rivas, MD	UTSouthwestern

Principal Investigator:	Daniel Scott, MD	UT Southwestern

Principal Investigator:	Esteban Varela, MD, MPH	UT Southwestern and VA North Texas

More Information

Surgeons complete North Texas' first single-incision gallbladder removal This link exits the ClinicalTrials.gov site

Responsible Party:	UT Southwestern ( Homero Rivas )
Study ID Numbers:	8843
First Received:	May 14, 2008
Last Updated:	August 25, 2008
ClinicalTrials.gov Identifier:	NCT00678873
Health Authority:	United States: Federal Government

Keywords provided by North Texas Veterans' Healthcare System:

Single Incision

Single Access

Surgery

Cholecystectomy

Study placed in the following topic categories:

Pathological Conditions, Anatomical

Gallbladder Diseases

Cholecystolithiasis

Digestive System Diseases

Cholelithiasis

Gallstones

Biliary Tract Diseases

Calculi

ClinicalTrials.gov processed this record on August 29, 2008

Sponsors and Collaborators:	University of Texas Southwestern Medical Center North Texas Veterans' Healthcare System
Information provided by:	North Texas Veterans' Healthcare System
ClinicalTrials.gov Identifier:	NCT00678873