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

This study has been withdrawn prior to enrollment.
(the manufacturer never released the instruments)
Ethicon Endo-Surgery
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center Identifier:
First received: June 1, 2010
Last updated: September 15, 2015
Last verified: August 2015

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
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

Enrollment: 0
Study Start Date: November 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (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.


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

Inclusion Criteria:

  • Uncomplicated Biliary Colic
  • ASA I or II

Exclusion Criteria:

  • Pregnant Women
  • Children
  • Institutionalized mentally disabled
  • Prisoners
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01146184

United States, New York
St Luke's-Roosevelt Hospital Center
New York, New York, United States, 10025
Sponsors and Collaborators
St. Luke's-Roosevelt Hospital Center
Ethicon Endo-Surgery
Principal Investigator: Julio Teixeira, MD St Luke's Roosevelt Hospital Center- Surgery Department
  More Information

Responsible Party: St. Luke's-Roosevelt Hospital Center Identifier: NCT01146184     History of Changes
Other Study ID Numbers: NCT01038181
Study First Received: June 1, 2010
Last Updated: September 15, 2015
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical processed this record on October 08, 2015