Pain Clinical Trial
Official title:
Single Incision Laparoscopic Cholecystectomy Using a Flexible Endoscope and Ethicon Manually Articulating Devices (MAD)
The aim of this study is to improve the technique of laparoscopic cholecystectomy by using a flexible endoscope passed through a single umbilical skin incision, as previously reported, now with the use of Manually Articulating Devices (Ethicon Endo-Surgery, Inc.) through the endoscope.
Single incision laparoscopic surgeries (SILS) have taken a step further the field of
minimally invasive surgery with reports of a variety of laparoscopic procedures performed
through a single incision.
However the technique is challenging due to the proximity of the instruments passed through
the single umbilical skin incision. Several improvisions were made to accommodate this
technical restriction by making flexible umbilical ports that accommodate several trocars,
or usage of different length instruments to strategically place the surgeons, minimizing
collision and improving ergonomics.
The flexibility of the endoscope will allow improved freedom of movement within the
abdominal cavity and ease of gallbladder dissection. The investigators believe that this
technique will take advantage of the flexible nature of the endoscope while avoiding the
risks of transluminal surgery inherent in natural orifice surgery. Flexible endoscope offers
an excellent solution to SILS, with its flexible optics and ability to pass working
instruments through it.
The flexible endoscope to be used ia a 12mm dual channel Karl Storz or Olympus
gastroscope.Ethicon instruments are essentially like traditional endoscopic instruments with
an extra joint at the working end, mimicking a wrist joint. These instruments are FDA
listed/cleared pursuant to 510(k) provisions of the Food, Drug and Cosmetic Act with general
indications for use in endoscopic or laparoscopic procedures. We will be using an
articulating grasper, articulating biopsy forcepts, and an articulating needle knife.
We will measure pain with pain scales.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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