Single Incision Laparoscopic Cholecystectomy Using a Flexible Endoscope and Ethicon Manually Articulating Devices (MAD)

Pain Clinical Trial

— IRB#08-181  

Official title:

Single Incision Laparoscopic Cholecystectomy Using a Flexible Endoscope and Ethicon Manually Articulating Devices (MAD)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01146184
• Other study ID #: 08-181
• Status: Withdrawn
• Phase: N/A
• First received: June 1, 2010
• Last updated: March 4, 2016
• Start date: November 2009
• Est. completion date: November 2009

Study information

• Verified date: August 2015
• Source: St. Luke's-Roosevelt Hospital Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Uncomplicated Biliary Colic

• ASA I or II

Exclusion Criteria:

• Pregnant Women

• Children

• Institutionalized mentally disabled

• Prisoners

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones
• Pain

Intervention

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.

Locations

Country	Name	City	State
United States	St Luke's-Roosevelt Hospital Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
St. Luke's-Roosevelt Hospital Center	Ethicon Endo-Surgery

Country where clinical trial is conducted

United States, 

References & Publications (4)

Ng WT, Kong CK, Wong YT. One-wound laparoscopic cholecystectomy. Br J Surg. 1997 Nov;84(11):1627. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Intra-Operative	No
Secondary	Post-operative Pain	Single-Incision laparoscopic cholecystectomy to reduce pain, improve patient outcomes and minimize invasiveness.	1 month	No
Secondary	Complications	Measure intra-operative and post-operative complications	1 month	No