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NOTES-Assisted Laparoscopic Cholecystectomy Surgery
This study is currently recruiting participants.
Study NCT00486655   Information provided by USGI Medical
First Received: June 12, 2007   Last Updated: June 13, 2007   History of Changes

June 12, 2007
June 13, 2007
May 2007
 
Quality of Life [ Time Frame: 2 weeks ]
Same as current
Complete list of historical versions of study NCT00486655 on ClinicalTrials.gov Archive Site
Incidence of complications [ Time Frame: 2 weeks ]
Same as current
 
NOTES-Assisted Laparoscopic Cholecystectomy Surgery
 

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.

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.

 
Interventional
Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
  • Cholelithiasis
  • Cholecystitis
Procedure: NOTES-Assisted Cholecystectomy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
25
June 2007
 

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
Both
18 Years to 85 Years
No
 
United States
 
NCT00486655
 
LS0701
USGI Medical
 
Principal Investigator: Lee Swanstrom, MD Oregon Clinic
USGI Medical
June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP