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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00848146 |
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Date of registration:
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19/02/2009 |
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Primary sponsor: |
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Public title:
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NOTES-Assisted Laparoscopic Cholecystectomy Surgery
TAS-NOTES |
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Scientific title:
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Natural Orifice Translumenal Endoscopic Surgery (NOTES)-Assisted Laparoscopic Cholecystectomy Surgery |
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Date of first enrolment:
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February 2009 |
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Target sample size:
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4 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00848146 |
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Study type:
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Interventional |
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Study design:
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Eric S Hungness, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Northwestern University |
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Key inclusion & exclusion criteria
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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 esophagogastroduodenoscopy (EGD)
- Presence of common duct stones
- Presence of esophageal stricture
- Altered gastric anatomy
- Gallstone greater than 1.5cm diameter seen on pre-op ultrasound
- Pregnancy
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cholecystectomy, Laparoscopic
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Endoscopy
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Intervention(s)
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Procedure: Endoscopically assisted Laparoscopic Cholecystectomy Surgery
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Primary Outcome(s)
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post operative pain
[Time Frame: two weeks]
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Secondary Outcome(s)
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quality of life
[Time Frame: two weeks]
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Secondary ID(s)
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23522
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NU IRB# 1452-006
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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