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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01146184
Recruitment Status : Withdrawn (the manufacturer never released the instruments)
First Posted : June 17, 2010
Last Update Posted : March 7, 2016
Ethicon Endo-Surgery
Information provided by (Responsible Party):
St. Luke's-Roosevelt Hospital Center

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.

Condition or disease Intervention/treatment Phase
Cholelithiasis Pain Device: Flexible endoscope and Ethicon Manually Articulating Device Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Single Incision Laparoscopic Cholecystectomy Using a Flexible Endoscope and Ethicon Manually Articulating Devices (MAD)
Study Start Date : November 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Post-operative Pain [ Time Frame: 1 month ]
    Single-Incision laparoscopic cholecystectomy to reduce pain, improve patient outcomes and minimize invasiveness.

  2. Complications [ Time Frame: 1 month ]
    Measure intra-operative and post-operative complications

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Uncomplicated Biliary Colic
  • ASA I or II

Exclusion Criteria:

  • Pregnant Women
  • Children
  • Institutionalized mentally disabled
  • Prisoners

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: St. Luke's-Roosevelt Hospital Center Identifier: NCT01146184     History of Changes
Other Study ID Numbers: 08-181
First Posted: June 17, 2010    Key Record Dates
Last Update Posted: March 7, 2016
Last Verified: August 2015

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

Additional relevant MeSH terms:
Surgical Wound
Wounds and Injuries
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Pathological Conditions, Anatomical