NOTES-Assisted Laparoscopic Cholecystectomy Surgery

This study has been terminated.
(Change of Focus for the company)
Sponsor:
Information provided by:
USGI Medical
ClinicalTrials.gov Identifier:
NCT00486655
First received: June 12, 2007
Last updated: August 7, 2012
Last verified: August 2012

June 12, 2007
August 7, 2012
May 2007
Not Provided
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
Not Provided
Not Provided
 
NOTES-Assisted Laparoscopic Cholecystectomy Surgery
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
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cholelithiasis
  • Cholecystitis
Procedure: NOTES-Assisted Cholecystectomy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
25
June 2007
Not Provided

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
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00486655
LS0701
No
Not Provided
USGI Medical
Not Provided
Principal Investigator: Lee Swanstrom, MD Oregon Clinic
USGI Medical
August 2012

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