Single Incision Laparoscopic Cholecystectomy Using a Flexible Endoscope and Ethicon Manually Articulating Devices (MAD) (IRB#08-181)
Primary Purpose
Cholelithiasis, Pain
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Flexible endoscope and Ethicon Manually Articulating Device
Sponsored by
About this trial
This is an interventional health services research trial for Cholelithiasis focused on measuring Cholelithiasis, Single Incision, Flexible Endoscope, Ethicon Manually Articulating Device, Pain
Eligibility Criteria
Inclusion Criteria:
- Uncomplicated Biliary Colic
- ASA I or II
Exclusion Criteria:
- Pregnant Women
- Children
- Institutionalized mentally disabled
- Prisoners
Sites / Locations
- St Luke's-Roosevelt Hospital Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single-Incision Cholecystectomy
Arm Description
Extracting the gallbladder laparoscopically is made difficult through a single incision.
Outcomes
Primary Outcome Measures
Improving the technique of laparoscopic Cholecystectomy with Flexible Endoscope and Ethicon Manually Articulating Device
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 Outcome Measures
Post-operative Pain
Single-Incision laparoscopic cholecystectomy to reduce pain, improve patient outcomes and minimize invasiveness.
Complications
Measure intra-operative and post-operative complications
Full Information
NCT ID
NCT01146184
First Posted
June 1, 2010
Last Updated
March 4, 2016
Sponsor
St. Luke's-Roosevelt Hospital Center
Collaborators
Ethicon Endo-Surgery
1. Study Identification
Unique Protocol Identification Number
NCT01146184
Brief Title
Single Incision Laparoscopic Cholecystectomy Using a Flexible Endoscope and Ethicon Manually Articulating Devices (MAD)
Acronym
IRB#08-181
Official Title
Single Incision Laparoscopic Cholecystectomy Using a Flexible Endoscope and Ethicon Manually Articulating Devices (MAD)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Withdrawn
Why Stopped
the manufacturer never released the instruments
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Luke's-Roosevelt Hospital Center
Collaborators
Ethicon Endo-Surgery
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiasis, Pain
Keywords
Cholelithiasis, Single Incision, Flexible Endoscope, Ethicon Manually Articulating Device, Pain
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single-Incision Cholecystectomy
Arm Type
Experimental
Arm Description
Extracting the gallbladder laparoscopically is made difficult through a single incision.
Intervention Type
Device
Intervention Name(s)
Flexible endoscope and Ethicon Manually Articulating Device
Other Intervention Name(s)
Single Incision cholecystectomy using flexible endoscope, Ethicon instruments
Intervention Description
Using the Flexible Endoscope and the Ethicon Manually Articulating Device, removal of the gallbladder through a single incision is improved.
Primary Outcome Measure Information:
Title
Improving the technique of laparoscopic Cholecystectomy with Flexible Endoscope and Ethicon Manually Articulating Device
Description
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.
Time Frame
Intra-Operative
Secondary Outcome Measure Information:
Title
Post-operative Pain
Description
Single-Incision laparoscopic cholecystectomy to reduce pain, improve patient outcomes and minimize invasiveness.
Time Frame
1 month
Title
Complications
Description
Measure intra-operative and post-operative complications
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Uncomplicated Biliary Colic
ASA I or II
Exclusion Criteria:
Pregnant Women
Children
Institutionalized mentally disabled
Prisoners
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julio Teixeira, MD
Organizational Affiliation
St Luke's Roosevelt Hospital Center- Surgery Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Luke's-Roosevelt Hospital Center
City
New York
State/Province
New York
ZIP/Postal Code
10025
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
9393287
Citation
Ng WT, Kong CK, Wong YT. One-wound laparoscopic cholecystectomy. Br J Surg. 1997 Nov;84(11):1627. No abstract available.
Results Reference
background
PubMed Identifier
19560980
Citation
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.
Results Reference
background
PubMed Identifier
1926312
Citation
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.
Results Reference
background
PubMed Identifier
7638995
Citation
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.
Results Reference
background
Learn more about this trial
Single Incision Laparoscopic Cholecystectomy Using a Flexible Endoscope and Ethicon Manually Articulating Devices (MAD)
We'll reach out to this number within 24 hrs