NOTES-Assisted Laparoscopic Cholecystectomy Surgery

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: NCT00486655
Recruitment Status : Terminated (Change of Focus for the company)
First Posted : June 14, 2007
Last Update Posted : August 8, 2012
Information provided by:
USGI Medical

Brief Summary:
This study proposes to evaluate the ability to reduce the size and number of laparoscopic incisions required to perform gall bladder removal by using flexible endoscopic instruments introduced through the mouth, into the stomach and through the stomach wall.

Condition or disease Intervention/treatment
Cholelithiasis Cholecystitis Procedure: NOTES-Assisted Cholecystectomy

Detailed Description:

A typical laparoscopic gall bladder removal procedure requires placement of a rigid laparoscope through a 1.5-2.5 cm incision in the umbilicus and then 2-3 additional 0.5 cm incisions for additional instrumentation. While post-operative complication rates for this procedure are small, wound infection, particularly of the large incision, is one of the most common post-operative complications. There is also a risk of a post-operative hernia at these incision sites.

A less invasive surgical technique that reduces the size or number of laparoscopic incisions offers the potential clinical benefits of eliminating wound infections, hernias and decreasing post-operative pain following laparoscopic gall bladder removal.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assisted Laparoscopic Cholecystectomy Surgery
Study Start Date : May 2007
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Quality of Life [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Incidence of complications [ Time Frame: 2 weeks ]

Information from the National Library of Medicine

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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 EGD
  • Presence of common duct stones
  • Presence of esophageal stricture
  • Altered gastric anatomy

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): NCT00486655

United States, Oregon
Oregon Clinic
Portland, Oregon, United States, 97210
Sponsors and Collaborators
USGI Medical
Principal Investigator: Lee Swanstrom, MD Oregon Clinic Identifier: NCT00486655     History of Changes
Other Study ID Numbers: LS0701
First Posted: June 14, 2007    Key Record Dates
Last Update Posted: August 8, 2012
Last Verified: August 2012

Keywords provided by USGI Medical:

Additional relevant MeSH terms:
Acalculous Cholecystitis
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Pathological Conditions, Anatomical