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Assessment of the Use of a Flexible Endoscope to Reduce Incisions and Ports for Laparoscopic Cholecystectomy
This study is currently recruiting participants.
Verified by University of Missouri-Columbia, January 2009
Sponsored by: University of Missouri-Columbia
Information provided by: University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00821704
  Purpose

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


Condition
Cholelithiasis
Choledocholithiasis
Biliary Dyskinesia

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia
MedlinePlus related topics: Gallstones
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Assessment of the Use of a Flexible Endoscope to Reduce Incisions and Ports for Laparascopic Cholecystectomy

Further study details as provided by University of Missouri-Columbia:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 10
Study Start Date: September 2008
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Potential subjects will be recruited from the attending surgeons' clinics. The primary investigator designee will be notified of a potential study participant by patient's attending physician. Subjects who meet selection criteria will be offered the opportunity to enroll into the study at the time of their pre-operative clinic.

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00821704

Locations
United States, Missouri
University of Missouri Health Care Recruiting
Columbia, Missouri, United States, 65212
Contact: Kelly M Sullivan, RN     573-884-7211     sullivankm@health.missouri.edu    
Principal Investigator: Brent Miedema, MD            
Sponsors and Collaborators
University of Missouri-Columbia
  More Information

Responsible Party: University of Missouri Healthcare ( Dr. Brent Miedema )
Study ID Numbers: 1121177
Study First Received: January 9, 2009
Last Updated: January 12, 2009
ClinicalTrials.gov Identifier: NCT00821704  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Cholecystolithiasis
Gallbladder Diseases
Pathological Conditions, Anatomical
Cholelithiasis
Gallstones
Central Nervous System Diseases
Calculi
Choledocholithiasis
Dyskinesias
Signs and Symptoms
Digestive System Diseases
Bile Duct Diseases
Movement Disorders
Biliary Tract Diseases
Neurologic Manifestations
Biliary Dyskinesia

Additional relevant MeSH terms:
Common Bile Duct Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009