Full Text View
Tabular View
No Study Results Posted
Related Studies
NOTES-Assisted Laparoscopic Cholecystectomy Surgery (TAS-NOTES)
This study is currently recruiting participants.
Verified by Northwestern University, February 2009
First Received: February 19, 2009   No Changes Posted
Sponsors and Collaborators: Northwestern University
Ethicon Endo-Surgery
Information provided by: Northwestern University
ClinicalTrials.gov Identifier: NCT00848146
  Purpose

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 Intervention
Cholecystectomy, Laparoscopic
Endoscopy
Procedure: Endoscopically assisted Laparoscopic Cholecystectomy Surgery

Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment
Official Title: Natural Orifice Translumenal Endoscopic Surgery (NOTES)-Assisted Laparoscopic Cholecystectomy Surgery

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • post operative pain [ Time Frame: two weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • quality of life [ Time Frame: two weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: February 2009
Estimated Study Completion Date: March 2011
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
NOTES-Assisted Lap Chole: Experimental
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00848146

Contacts
Contact: Eric S Hungness, M.D. 312-695-1419 ehungnes@nmh.org
Contact: Edward Auyang, M.D., M.S. 312-926-9535 edwardauyang@gmail.com

Locations
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Hungness     312-695-1419     ehungness@nmh.org    
Contact: Auyang     312-926-9535     edwardauyang@gmail.com    
Principal Investigator: Eric S Hungness, M.D.            
Sponsors and Collaborators
Northwestern University
Ethicon Endo-Surgery
Investigators
Principal Investigator: Eric S Hungness, M.D. Northwestern University
  More Information

No publications provided

Responsible Party: Northwestern University ( Eric S. Hungness, M.D. / Assistant Professor of Surgery )
Study ID Numbers: 23522, NU IRB# 1452-006
Study First Received: February 19, 2009
Last Updated: February 19, 2009
ClinicalTrials.gov Identifier: NCT00848146     History of Changes
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 30, 2009