Assessment of the Use of a Flexible Endoscope to Reduce Incisions and Ports for Laparoscopic Cholecystectomy - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields
Brief Title ^†	Assessment of the Use of a Flexible Endoscope to Reduce Incisions and Ports for Laparoscopic Cholecystectomy
Official Title ^†	Assessment of the Use of a Flexible Endoscope to Reduce Incisions and Ports for Laparascopic Cholecystectomy
Brief Summary	This study will be conducted as a prospective, single site, non-randomized, single arm study among elective patients. The primary purpose of this study is to try to reduce the number of laparoscopic ports and skin incisions that are necessary to perform a cholecystectomy
Detailed Description	Surgical removal of the gallbladder is needed in 1 million people per year in the USA. The procedure is done by placing four tubes (cannula) from 5 to 10 mm through the abdominal wall. Air is placed in the abdominal cavity and a lighted scope is placed through one cannula. The space in the abdominal cavity can then be seen on a video screen. Thin retractors and dissecting instruments are placed through the other cannula and the gallbladder is removed using the video screen for vision. The gallbladder duct and the artery are usually occluded with clips or stitches. In this study we propose to do the procedure though a single 13 mm incision placed at the umbilicus. This will be possible using a flexible endoscope with one or two working channels. The gallbladder will then be retracted using strings (sutures) attached to the gallbladder and brought out through the right side of the abdominal wall through a needle puncture site. The dissection will be done using flexible instruments (scissors, knives, dissectors) placed through the right working channel. A flexible grasper may be used in the left working channel to help with retraction. This study evaluates the ability to do laparoscopic cholecystectomy with a single incision. This will provide the basis for future studies evaluating decreased pain and costs with single port cholecystectomy.
Study Phase
Study Type ^†	Observational
Study Design ^†	Case-Only, Prospective
Primary Outcome Measure ^†
Secondary Outcome Measure ^†
Condition ^†	Cholelithiasis Choledocholithiasis Biliary Dyskinesia
Intervention ^†
MEDLINE PMIDs
Links

Recruitment Information Fields
Recruitment Status ^†	Recruiting
Enrollment ^†	10
Start Date ^†	September 2008
Completion Date	September 2009
Eligibility Criteria ^†	Inclusion Criteria: Age 18 yrs or older Diagnosis of cholelithiasis,choledocholithiasis or biliary dyskinesia and scheduled for laparoscopic cholecystectomy Have an indication for a standard laparoscopic procedure cholecystectomy Females: Not pregnant Exclusion Criteria: Any significant comorbidities, including significant cardiac disease, history of stroke, severe pulmonary disease, hypertension with a diastolic greater than 100, pancreatitis. Patients that are immunosuppressed or on immunosuppression therapy. An unacceptable psychological or medical risk as determined by the primary investigators.
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^††
Location Countries ^†	United States

Administrative Information Fields
NCT ID ^†	NCT00821704
Organization ID	1121177
Secondary IDs ^††
Study Sponsor ^†	University of Missouri-Columbia
Collaborators ^††
Investigators ^†
Information Provided By	University of Missouri-Columbia
Verification Date	January 2009
First Received Date ^†	January 9, 2009
Last Updated Date	January 12, 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.