Cholelithiasis, Pain
Conditions
Keywords
Cholelithiasis, Single Incision, Flexible Endoscope, Ethicon Manually Articulating Device, Pain
Brief summary
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.
Detailed description
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.
Interventions
DEVICEFlexible 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.
Sponsors
Ethicon Endo-Surgery
St. Luke's-Roosevelt Hospital Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Uncomplicated Biliary Colic * ASA I or II
Exclusion criteria
* Pregnant Women * Children * Institutionalized mentally disabled * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improving the technique of laparoscopic Cholecystectomy with Flexible Endoscope and Ethicon Manually Articulating Device | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain | 1 month | Single-Incision laparoscopic cholecystectomy to reduce pain, improve patient outcomes and minimize invasiveness. |
| Complications | 1 month | Measure intra-operative and post-operative complications |
Countries
United States
Outcome results
None listed