- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01146184
Single Incision Laparoscopic Cholecystectomy Using a Flexible Endoscope and Ethicon Manually Articulating Devices (MAD) (IRB#08-181)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10025
- St Luke's-Roosevelt Hospital Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Uncomplicated Biliary Colic
- ASA I or II
Exclusion Criteria:
- Pregnant Women
- Children
- Institutionalized mentally disabled
- Prisoners
Study Plan
How is the study designed?
Design Details
- Primary Purpose: HEALTH_SERVICES_RESEARCH
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Single-Incision Cholecystectomy
Extracting the gallbladder laparoscopically is made difficult through a single incision.
|
Using the Flexible Endoscope and the Ethicon Manually Articulating Device, removal of the gallbladder through a single incision is improved.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Intra-Operative
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-operative Pain
Time Frame: 1 month
|
Single-Incision laparoscopic cholecystectomy to reduce pain, improve patient outcomes and minimize invasiveness.
|
1 month
|
Complications
Time Frame: 1 month
|
Measure intra-operative and post-operative complications
|
1 month
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Julio Teixeira, MD, St Luke's Roosevelt Hospital Center- Surgery Department
Publications and helpful links
General Publications
- Ng WT, Kong CK, Wong YT. One-wound laparoscopic cholecystectomy. Br J Surg. 1997 Nov;84(11):1627. No abstract available.
- Teixeira J, McGill K, Koshy N, McGinty J, Todd G. Laparoscopic single-site surgery for placement of adjustable gastric band--a series of 22 cases. Surg Obes Relat Dis. 2010 Jan-Feb;6(1):41-5. doi: 10.1016/j.soard.2009.03.220. Epub 2009 Apr 16.
- Petersen LR, Doll LS. Human immunodeficiency virus type 1-infected blood donors: epidemiologic, laboratory, and donation characteristics. The HIV Blood Donor Study Group. Transfusion. 1991 Oct;31(8):698-703. doi: 10.1046/j.1537-2995.1991.31892023493.x.
- Slim K, Pezet D, Stencl J Jr, Lechner C, Le Roux S, Lointier P, Chipponi J. Laparoscopic cholecystectomy: an original three-trocar technique. World J Surg. 1995 May-Jun;19(3):394-7. doi: 10.1007/BF00299168.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-181
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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