NOTES-Assisted Laparoscopic Cholecystectomy Surgery
Primary Purpose
Cholelithiasis, Cholecystitis
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NOTES-Assisted Cholecystectomy
Sponsored by
About this trial
This is an interventional treatment trial for Cholelithiasis focused on measuring Cholecystectomy, NOTES, Transgastric
Eligibility 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
Sites / Locations
- Oregon Clinic
Outcomes
Primary Outcome Measures
Quality of Life
Secondary Outcome Measures
Incidence of complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00486655
Brief Title
NOTES-Assisted Laparoscopic Cholecystectomy Surgery
Official Title
Assisted Laparoscopic Cholecystectomy Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Why Stopped
Change of Focus for the company
Study Start Date
May 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
USGI Medical
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiasis, Cholecystitis
Keywords
Cholecystectomy, NOTES, Transgastric
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
NOTES-Assisted Cholecystectomy
Primary Outcome Measure Information:
Title
Quality of Life
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Incidence of complications
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee Swanstrom, MD
Organizational Affiliation
Oregon Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Clinic
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
12. IPD Sharing Statement
Learn more about this trial
NOTES-Assisted Laparoscopic Cholecystectomy Surgery
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