Transvaginal Cholecystectomy Using 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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Laparoscopic Cholecystectomy Using Transvaginal Endoscopic Assistance|
- Reduction in the number of laparoscopic ports [ Time Frame: Time of surgery ] [ Designated as safety issue: Yes ]
- Cost analysis comparison of surgical procedures. [ Time Frame: Cost analysis will be done at end of study. ] [ Designated as safety issue: No ]
- Time of procedure [ Time Frame: Time recorded during surgical procedure. ] [ Designated as safety issue: No ]
- Cosmesis and pain [ Time Frame: Prior to procedure, 1 to 3 days post op, 7 to 10 days post op, and at follow-up visit ~6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||January 2009|
|Study Completion Date:||May 2011|
|Primary Completion Date:||May 2011 (Final data collection date for primary outcome measure)|
Experimental: Surgical Procedure
Laparoscopic transvaginal cholecystectomy with endoscopic assistance.
Patients enrolled in the study will have a flexible transvaginal endoscopy used during laparoscopic cholecystectomy.
Other Name: Gallbladder removal
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00815438
|Principal Investigator:||Brent Miedema, MD||University of Missouri-Columbia|