NOTES-Assisted Laparoscopic Cholecystectomy Surgery - Full Text View

Sponsor:	USGI Medical
Information provided by:	USGI Medical
ClinicalTrials.gov Identifier:	NCT00486655

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:	Treatment, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Gallstones Surgery

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
Estimated 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	Recruiting
Portland, Oregon, United States, 97210
Contact: Lisa Leeth 503-963-2872 lleeth@orclinic.com

Sponsors and Collaborators

USGI Medical

Investigators

Principal Investigator:

Lee Swanstrom, MD

Oregon Clinic

More Information

No publications provided

Study ID Numbers:	LS0701
Study First Received:	June 12, 2007
Last Updated:	June 13, 2007
ClinicalTrials.gov Identifier:	NCT00486655 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by USGI Medical:

Cholecystectomy
NOTES
Transgastric

Additional relevant MeSH terms:

Pathological Conditions, Anatomical
Gallbladder Diseases
Cholecystolithiasis
Digestive System Diseases
Cholelithiasis

Gallstones
Acalculous Cholecystitis
Biliary Tract Diseases
Cholecystitis
Calculi

ClinicalTrials.gov processed this record on November 27, 2009