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Study 19 of 420 for search of: | received on or after 12/30/2008 |
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Sponsored by: |
University of Missouri-Columbia |
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Information provided by: | University of Missouri-Columbia |
ClinicalTrials.gov Identifier: | NCT00821704 |
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 |
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Cholelithiasis Choledocholithiasis Biliary Dyskinesia |
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 |
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) |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.
Inclusion Criteria:
Exclusion Criteria:
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 |
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 |
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 |
Common Bile Duct Diseases Nervous System Diseases |