Single Incision Laparoscopic Cholecystectomy - Tabular View

Tracking Information

First Received Date ^ICMJE

May 14, 2008

Last Updated Date

September 12, 2008

Start Date ^ICMJE

March 2008

Estimated Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety and feasibility [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00678873 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Short-term clinical outcomes [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Single Incision Laparoscopic Cholecystectomy

Official Title ^ICMJE

Single Incision Laparoscopic Cholecystectomy

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.

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 Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Cholelithiasis

Intervention ^ICMJE

Procedure: Single Incision Laparoscopic Cholecystectomy

Study Arms / Comparison Groups

Experimental: Patients with ultrasound proven symptomatic cholelithiasis (gallstones).

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2009

Estimated Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00678873

Responsible Party

Homero Rivas and Daniel Scott, UT Southwestern

Study ID Numbers ^ICMJE

8843

Study Sponsor ^ICMJE

University of Texas Southwestern Medical Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:	Homero Rivas, MD	UTSouthwestern
Principal Investigator:	Daniel Scott, MD	UT Southwestern
Principal Investigator:	Esteban Varela, MD, MPH	UT Southwestern

Information Provided By

North Texas Veterans Healthcare System

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP