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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
History of Changes
  Purpose

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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assisted Laparoscopic Cholecystectomy Surgery

Resource links provided by NLM:

MedlinePlus related topics: Gallstones
U.S. FDA Resources

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.

  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 EGD
  • Presence of common duct stones
  • Presence of esophageal stricture
  • Altered gastric anatomy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00486655

Locations
United States, Oregon
Oregon Clinic
Portland, Oregon, United States, 97210
Sponsors and Collaborators
USGI Medical
Investigators
Principal Investigator: Lee Swanstrom, MD Oregon Clinic
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00486655     History of Changes
Other Study ID Numbers: LS0701
Study First Received: June 12, 2007
Last Updated: August 7, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by USGI Medical:
Cholecystectomy
NOTES
Transgastric

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

ClinicalTrials.gov processed this record on May 23, 2013