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

Not Applicable

Withdrawn

• Conditions: Pain; Cholelithiasis
• Interventions: Device: Flexible endoscope and Ethicon Manually Articulating Device

• Registration Number: NCT01146184
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-11
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Study First Submitted: 2010-06-01
• Study First Submitted QC: 2010-06-15
• Study First Posted: 2010-06-17
• Status Verified: 2015-08
• Last Update Submitted: 2016-03-04
• Last Update Posted: 2016-03-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Uncomplicated Biliary Colic
• ASA I or II

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Exclusion Criteria

• Pregnant Women
• Children
• Institutionalized mentally disabled
• Prisoners

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single-Incision Cholecystectomy	Flexible endoscope and Ethicon Manually Articulating Device	Extracting the gallbladder laparoscopically is made difficult through a single incision.

Primary Outcome Measures

Name	Time	Method
Improving the technique of laparoscopic Cholecystectomy with Flexible Endoscope and Ethicon Manually Articulating Device	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

Name	Time	Method
Post-operative Pain	1 month	Single-Incision laparoscopic cholecystectomy to reduce pain, improve patient outcomes and minimize invasiveness.
Complications	1 month	Measure intra-operative and post-operative complications

Trial Locations

Locations (1)

St Luke's-Roosevelt Hospital Center; 🇺🇸 New York, New York, United States