Economisation of Whipple Resection Using an Ultrasonic Dissection Device
This study has been completed.
Sponsor:
Universitätsklinikum Hamburg-Eppendorf
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01321450
First received: January 24, 2011
Last updated: November 5, 2011
Last verified: November 2011
| Tracking Information | |||||
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| First Received Date ICMJE | January 24, 2011 | ||||
| Last Updated Date | November 5, 2011 | ||||
| Start Date ICMJE | March 2009 | ||||
| Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Total operation time [ Time Frame: end of operation ] [ Designated as safety issue: No ] Measurement of time regarding incision-closure-time |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01321450 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 | Economisation of Whipple Resection Using an Ultrasonic Dissection Device | ||||
| Official Title ICMJE | Economisation of Preparation by Using an Ultrasonic Dissection Device in Partial Pancreatoduodenectomy | ||||
| Brief Summary | Including 150 randomised patient, the studies aim is to determine whether an economisation and/or improvement in terms of operating time, drainage fluid, blood loss, time of hospitalisation can be found using an ultrasonic dissection device versus traditional surgical methods such as stitches an ligations.The study is performed for patients undergoing partial pancreatoduodenectomy. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients planned for partial pancreatoduodenectomy for pancreatic head carcinoma, periampullary carcinoma, chronic pancreatitis and other benign lesions. |
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| Condition ICMJE | Patients Planned for Partial Pancreatoduodenectomy for Pancreatic Head Carcinoma, Periampullary Carcinoma, Chronic Pancreatitis and Other Benign Lesions. | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * |
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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 | Completed | ||||
| Estimated Enrollment ICMJE | 150 | ||||
| Completion Date | October 2011 | ||||
| Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: resectable tumor Exclusion Criteria: palliative resection |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany, Greece, Italy | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01321450 | ||||
| Other Study ID Numbers ICMJE | 2908 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Universitätsklinikum Hamburg-Eppendorf | ||||
| Study Sponsor ICMJE | Universitätsklinikum Hamburg-Eppendorf | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Universitätsklinikum Hamburg-Eppendorf | ||||
| Verification Date | November 2011 | ||||
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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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