Single Incision Laparoscopic Cholecystectomy Using a Flexible Endoscope and Ethicon Manually Articulating Devices (MAD) (IRB#08-181)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by St. Luke's-Roosevelt Hospital Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ethicon Endo-Surgery
Information provided by:
St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier:
NCT01146184
First received: June 1, 2010
Last updated: June 15, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention
Cholelithiasis
Pain
Device: Flexible endoscope and Ethicon Manually Articulating Device

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Single Incision Laparoscopic Cholecystectomy Using a Flexible Endoscope and Ethicon Manually Articulating Devices (MAD)

Resource links provided by NLM:


Further study details as provided by St. Luke's-Roosevelt Hospital Center:

Primary Outcome Measures:
  • Improving the technique of laparoscopic Cholecystectomy with Flexible Endoscope and Ethicon Manually Articulating Device [ Time Frame: Intra-Operative ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Single-Incision laparoscopic cholecystectomy to reduce pain, improve patient outcomes and minimize invasiveness.

  • Complications [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Measure intra-operative and post-operative complications


Estimated Enrollment: 15
Study Start Date: November 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • Single Incision cholecystectomy using flexible endoscope
  • Ethicon instruments

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Uncomplicated Biliary Colic
  • ASA I or II

Exclusion Criteria:

  • Pregnant Women
  • Children
  • Institutionalized mentally disabled
  • Prisoners
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01146184

Locations
United States, New York
St Luke's-Roosevelt Hospital Center Recruiting
New York, New York, United States, 10025
Contact: Julio Teixeira, MD    212-636-1000    JTeixeira@chpnet.org   
Contact: Beatriz Ryan, BA    212 636 1000    bryan@chpnet.org   
Principal Investigator: Julio Teixeira, MD         
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Ethicon Endo-Surgery
Investigators
Principal Investigator: Julio Teixeira, MD St Luke's Roosevelt Hospital Center- Surgery Department
  More Information

Publications:
Responsible Party: Julio Teixeira, MD, St. Luke's-Roosevelt Hospital Center
ClinicalTrials.gov Identifier: NCT01146184     History of Changes
Other Study ID Numbers: NCT01038181
Study First Received: June 1, 2010
Last Updated: June 15, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by St. Luke's-Roosevelt Hospital Center:
Cholelithiasis
Single Incision
Flexible Endoscope
Ethicon Manually Articulating Device
Pain

Additional relevant MeSH terms:
Cholelithiasis
Cholecystolithiasis
Gallstones
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 17, 2014