NOTES-Assisted Laparoscopic Cholecystectomy Surgery (TAS-NOTES)

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: NCT00848146
Recruitment Status : Completed
First Posted : February 20, 2009
Last Update Posted : July 4, 2012
Ethicon Endo-Surgery
Information provided by (Responsible Party):
Eric Hungness, Northwestern University

Brief Summary:

Refinements in laparoscopic surgery, coupled with advancements in therapeutic flexible endoscopy, have set the stage for surgery to move to even less invasive techniques to treat conditions in the GI tract and peritoneal cavity. Natural orifice translumenal endoscopic surgery (NOTES) offers a means of reducing and ultimately eliminating the need for abdominal incisions to gain access to the peritoneal cavity. In NOTES, a flexible endoscope and accessory instruments are inserted through a natural body orifice and passed through the wall of an organ to reach the abdominal cavity. By reducing or eliminating the need for abdominal incisions, NOTES may provide a least invasive surgical option that can reduce pain, recovery time, complications, and systemic inflammatory response when compared to a laparoscopic surgical approach. In this study, we propose to use the NOTES technique to eliminate the need for a 1.5-2.5 cm umbilical incision.

Hypothesis 1: We hypothesize that a combined endoscopic and laparoscopic approach will be able to eliminate a 1.5 to 2.5 cm infraumbilical incision when performing a laparoscopic cholecystectomy.

Hypothesis 2: Closure of the gastrotomy will be facilitated with the Ethicon TAS system.

Condition or disease Intervention/treatment Phase
Cholecystectomy, Laparoscopic Endoscopy Procedure: Endoscopically assisted Laparoscopic Cholecystectomy Surgery Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Natural Orifice Translumenal Endoscopic Surgery (NOTES)-Assisted Laparoscopic Cholecystectomy Surgery
Study Start Date : February 2009
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: NOTES-Assisted Lap Chole
These patients will undergo an experimental surgical procedure that uses a combination of laparoscopic instruments (i.e., inserted through the skin into the abdominal cavity) and flexible endoscopic instruments (i.e., inserted through the mouth).
Procedure: Endoscopically assisted Laparoscopic Cholecystectomy Surgery
Using endoscopic instruments a small incision will be made in the gastric wall and the endoscope will be advanced into the insufflated peritoneal cavity. At least one laparoscopic trocars will be placed through the abdominal wall for laparoscopic instrument insertion to manipulate and cut tissue. The flexible endoscope will provide visualization of the surgical field and flexible endoscopic instruments may be used to augment surgical manipulation with the laparoscopic instruments. The gallbladder will be removed through the stomach and out of the mouth. Endoscopic clips, sutures or tissue anchors (TAS)will be used to close the gastrotomy.
Other Names:
  • Natural orifice translumenal endoscopic surgery
  • Transgastric Cholecystectomy

Primary Outcome Measures :
  1. post operative pain [ Time Frame: two weeks ]

Secondary Outcome Measures :
  1. quality of life [ Time Frame: two weeks ]

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Ability to undergo general anesthesia
  • Age > 18 yrs. of age and < 85 yrs. of age
  • Ability to give informed consent

Exclusion Criteria:

  • Acute cholecystitis
  • BMI > 40
  • Contraindicated for esophagogastroduodenoscopy (EGD)
  • Presence of common duct stones
  • Presence of esophageal stricture
  • Altered gastric anatomy
  • Gallstone greater than 1.5cm diameter seen on pre-op ultrasound
  • Pregnancy

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): NCT00848146

United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Ethicon Endo-Surgery
Principal Investigator: Eric S Hungness, M.D. Northwestern University

Responsible Party: Eric Hungness, Assistant professor of surgery, Northwestern University Identifier: NCT00848146     History of Changes
Other Study ID Numbers: 23522
NU IRB# 1452-006
First Posted: February 20, 2009    Key Record Dates
Last Update Posted: July 4, 2012
Last Verified: July 2012