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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
USGI Medical
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholelithiasis focused on measuring Cholecystectomy, NOTES, Transgastric

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 12, 2007
Last Updated
August 7, 2012
Sponsor
USGI Medical
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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

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NOTES-Assisted Laparoscopic Cholecystectomy Surgery

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