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NOTES-Assisted Laparoscopic Cholecystectomy Surgery

This study has been terminated.
(Change of Focus for the company)
Information provided by:
USGI Medical Identifier:
First received: June 12, 2007
Last updated: August 7, 2012
Last verified: August 2012
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 Intervention
Cholelithiasis Cholecystitis Procedure: NOTES-Assisted Cholecystectomy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assisted Laparoscopic Cholecystectomy Surgery

Resource links provided by NLM:

Further study details as provided by USGI Medical:

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

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

Estimated Enrollment: 25
Study Start Date: May 2007
Study Completion Date: June 2007
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.


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00486655

United States, Oregon
Oregon Clinic
Portland, Oregon, United States, 97210
Sponsors and Collaborators
USGI Medical
Principal Investigator: Lee Swanstrom, MD Oregon Clinic
  More Information Identifier: NCT00486655     History of Changes
Other Study ID Numbers: LS0701
Study First Received: June 12, 2007
Last Updated: August 7, 2012

Keywords provided by USGI Medical:

Additional relevant MeSH terms:
Acalculous Cholecystitis
Gallbladder Diseases
Biliary Tract Diseases
Digestive System Diseases
Pathological Conditions, Anatomical processed this record on August 16, 2017