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NOTES-Assisted Laparoscopic Cholecystectomy Surgery

This study has been terminated.
(Change of Focus for the company)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00486655
First Posted: June 14, 2007
Last Update Posted: August 8, 2012
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.
Information provided by:
USGI Medical
  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: Intervention Model: Single Group Assignment
Masking: None (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.

  Eligibility

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
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
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 ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00486655     History of Changes
Other Study ID Numbers: LS0701
First Submitted: June 12, 2007
First Posted: June 14, 2007
Last Update Posted: August 8, 2012
Last Verified: August 2012

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