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NOTES-Assisted Laparoscopic Cholecystectomy Surgery (TAS-NOTES)

This study has been completed.
Sponsor:
Collaborator:
Ethicon Endo-Surgery
Information provided by (Responsible Party):
Eric Hungness, Northwestern University
ClinicalTrials.gov Identifier:
NCT00848146
First received: February 19, 2009
Last updated: July 3, 2012
Last verified: July 2012
History of Changes
  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: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Natural Orifice Translumenal Endoscopic Surgery (NOTES)-Assisted Laparoscopic Cholecystectomy Surgery

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

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 ]

Enrollment: 4
Study Start Date: February 2009
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • NOTES
  • Natural orifice translumenal endoscopic surgery
  • Transgastric Cholecystectomy

  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

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
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: Eric Hungness, Assistant professor of surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT00848146     History of Changes
Other Study ID Numbers: 23522, NU IRB# 1452-006
Study First Received: February 19, 2009
Last Updated: July 3, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 19, 2013