Cholecystitis Clinical Trial
Official title:
Laparoscopic Cholecystectomy Using Transvaginal Endoscopic Assistance
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 5 mm incision placed at the
umbilicus and a second access through the vagina using a flexible endoscope. The gallbladder
will be retracted using strings (sutures) attached to the gallbladder. The dissection will
be done using laparoscopic instruments (scissors, knives, dissectors) placed through the
laparoscopic port. A flexible grasper may be used in the endoscope to help with retraction.
An endoscopic snare or grasper will be used to grasp the gallbladder and remove it from the
abdomen through the vagina.
This study evaluates the ability to do laparoscopic cholecystectomy with one skin incision
and one vaginal incision. This will provide the basis for future studies evaluating
decreased pain and costs with transvaginal assisted cholecystectomy.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Female age = 18 yrs - Diagnosis of cholelithiasis, cholecystectomy, choledocholithiasis or biliary dyskinesia and scheduled for laparoscopic cholecystectomy - Have an indication for a standard laparoscopic procedure cholecystectomy - Not pregnant Exclusion Criteria: - Any significant co-morbidities, 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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Missouri-Columbia |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction in the number of laparoscopic ports | Time of surgery | Yes | |
Secondary | Cost analysis comparison of surgical procedures. | Cost analysis will be done at end of study. | No | |
Secondary | Time of procedure | Time recorded during surgical procedure. | No | |
Secondary | Cosmesis and pain | Prior to procedure, 1 to 3 days post op, 7 to 10 days post op, and at follow-up visit ~6 weeks | No |
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