Single Incision Laparoscopic Cholecystectomy Using a Flexible Endoscope and Ethicon Manually Articulating Devices (MAD) (IRB#08-181)
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|ClinicalTrials.gov Identifier: NCT01146184|
Recruitment Status : Withdrawn (the manufacturer never released the instruments)
First Posted : June 17, 2010
Last Update Posted : March 7, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cholelithiasis Pain||Device: Flexible endoscope and Ethicon Manually Articulating Device||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Single Incision Laparoscopic Cholecystectomy Using a Flexible Endoscope and Ethicon Manually Articulating Devices (MAD)|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||November 2009|
|Actual Study Completion Date :||November 2009|
Experimental: Single-Incision Cholecystectomy
Extracting the gallbladder laparoscopically is made difficult through a single incision.
Device: Flexible endoscope and Ethicon Manually Articulating Device
Using the Flexible Endoscope and the Ethicon Manually Articulating Device, removal of the gallbladder through a single incision is improved.
- Improving the technique of laparoscopic Cholecystectomy with Flexible Endoscope and Ethicon Manually Articulating Device [ Time Frame: Intra-Operative ]Using flexible endoscopes and the Ethicon Manually Articulating Device will facilitate the procedure of removing the gallbladder by allowing more flexibility and greater movement in the abdominal cavity, better triangulation for dissection and increased quality of optics for the single-incision technique.
- Post-operative Pain [ Time Frame: 1 month ]Single-Incision laparoscopic cholecystectomy to reduce pain, improve patient outcomes and minimize invasiveness.
- Complications [ Time Frame: 1 month ]Measure intra-operative and post-operative complications
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01146184
|United States, New York|
|St Luke's-Roosevelt Hospital Center|
|New York, New York, United States, 10025|
|Principal Investigator:||Julio Teixeira, MD||St Luke's Roosevelt Hospital Center- Surgery Department|