From Acute to Chronic Postoperative Pain in Patients for Elective Cholecystectomy. Immunological Tests
This study is currently recruiting participants.
Verified March 2012 by Odense University Hospital
Sponsor:
Odense University Hospital
Collaborators:
Vejle Hospital
Oberstinde Kirsten Jensa la Cours Legat
Information provided by (Responsible Party):
Morten Rune Eckhardt, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01546480
First received: March 2, 2012
Last updated: March 9, 2012
Last verified: March 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | March 2, 2012 | ||||||||
| Last Updated Date | March 9, 2012 | ||||||||
| Start Date ICMJE | November 2011 | ||||||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Spinal interleukine levels [ Time Frame: 12 months ] [ Designated as safety issue: No ] 12 months after surgery |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01546480 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | From Acute to Chronic Postoperative Pain in Patients for Elective Cholecystectomy. Immunological Tests | ||||||||
| Official Title ICMJE | From Acute to Chronic Postoperative Pain in Patients for Elective Cholecystectomy. Immunological Tests | ||||||||
| Brief Summary | Chronic Pain after Cholecystectomy is a well known problem. One theory is that it is due to persisting inflammation. The purpose of the study is to measure inflammatory factors in cerebrospinal fluid and blod at patients 12 months after the operation. DNA-samples are collected to examine genetical factors, important for perception of pain, and the development of chronic pain. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Whole blood Serum Plasma Cerebrospinal fluid Saliva |
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients in group 1 and 2 previously participated in a study of postcholecystectomy pain. Patients in group 3 are patients scheduled for elective surgery in spinal anesthesia at the participating centres. |
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| Condition ICMJE | Pain | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 45 | ||||||||
| Estimated Completion Date | September 2012 | ||||||||
| Estimated Primary Completion Date | August 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Group 1: Inclusion Criteria:
Exclusion Criteria:
Group 2: Inclusion Criteria:
Exclusion Criteria:
Group 3: Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Denmark | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01546480 | ||||||||
| Other Study ID Numbers ICMJE | ImmT, 119 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Morten Rune Eckhardt, Odense University Hospital | ||||||||
| Study Sponsor ICMJE | Odense University Hospital | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Odense University Hospital | ||||||||
| Verification Date | March 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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