Clinical Trial: Transvaginal Cholecystectomy Using Endoscopic Assistance
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Laparoscopic Cholecystectomy Using Transvaginal Endoscopic Assistance
Brief Summary:
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.
Detailed Summary:
BACKGROUND When doing laparoscopic cholecystectomy, there are generally four ports placed through four separate skin incisions. One port is used for a rigid laparoscope, two for retraction, and one for dissecting. We have recently started to reduce the number of incisions for laparoscopic cholecystectomy to one umbilical incision. Three ports are used through one incision by suspending the gallbladder to the abdominal wall using sutures. This allows the surgeon to eliminate incisions and the patients have reduced postoperative wound pain and improved cosmesis. However, by using standard laparoscopic rigid instruments and optic systems it is challenging to perform this operation via a single incision.
Recently, natural orifice transluminal endoscopic surgery (NOTES) has been used in females to reduce the size and number of fascial incisions of the anterior abdominal wall. This vaginal approach has generally been done with the aid of laparoscopy (hybrid procedure). The vaginal assistance may allow small abdominal wall incisions resulting in less pain and faster recovery than after the standard laparoscopic approach.
We propose a phase I study of a laparoscopic cholecystectomy using a single 5 mm port and transvaginal endoscopic assistance in 10 female patients. The procedure will have at least one 5 mm laparoscopic port for safety and assistance. Conversions to conventional laparoscopic surgery will be done if difficulties are encountered.
OBJECTIVE Reduction in the number of ports required in laparoscopic cholecystectomy.
Null hypothesis: Laparoscopic cholecystectomy requires two or more fascial port sites to perform.
Alternative hypothesis: Laparoscopic cholecystectomy can be
Sponsor: University of Missouri-Columbia
Current Primary Outcome: Reduction in the number of laparoscopic ports [ Time Frame: Time of surgery ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Cost analysis comparison of surgical procedures. [ Time Frame: Cost analysis will be done at end of study. ]
- Time of procedure [ Time Frame: Time recorded during surgical procedure. ]
- 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 ]
Original Secondary Outcome: Same as current
Information By: University of Missouri-Columbia
Dates:
Date Received: December 29, 2008
Date Started: January 2009
Date Completion:
Last Updated: September 29, 2016
Last Verified: September 2016
