Anesthesia Management of Retroperitoneal Adrenalectomies
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Kliniken Essen-Mitte.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Kliniken Essen-Mitte
Information provided by:
Kliniken Essen-Mitte
ClinicalTrials.gov Identifier:
NCT00894335
First received: May 6, 2009
Last updated: June 27, 2011
Last verified: May 2009
| Tracking Information | |||||
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| First Received Date ICMJE | May 6, 2009 | ||||
| Last Updated Date | June 27, 2011 | ||||
| Start Date ICMJE | May 2008 | ||||
| Estimated Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Arterial-alveolar Carbon dioxide Difference [ Time Frame: 3 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00894335 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Perioperative maximal mean arterial pressure [ Time Frame: 3 Years ] [ Designated as safety issue: No ] | ||||
| 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 | Anesthesia Management of Retroperitoneal Adrenalectomies | ||||
| Official Title ICMJE | Anesthesiological Management of Hemodynamics and Gas Exchange for Retroperitoneal Adrenalectomies | ||||
| Brief Summary | This study is a prospective, perioperative evaluation of hemodynamic and respiratory parameters in patients undergoing retroperitoneoscopic adrenalectomies. |
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| Detailed Description | Due to their underlying disease, patients with adrenal tumors are prone to episodes of hyper- and hypotension. Furthermore, excessive hypercarbia and an increased arterial-alveolar CO2 difference can be seen during these operations. |
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| 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 with adrenal tumors scheduled for retroperitoneal adrenalectomies |
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| Condition ICMJE | Adrenal Tumors | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Walz MK, Alesina PF, Wenger FA, Deligiannis A, Szuczik E, Petersenn S, Ommer A, Groeben H, Peitgen K, Janssen OE, Philipp T, Neumann HP, Schmid KW, Mann K. Posterior retroperitoneoscopic adrenalectomy--results of 560 procedures in 520 patients. Surgery. 2006 Dec;140(6):943-8; discussion 948-50. | ||||
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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 | 500 | ||||
| Estimated Completion Date | July 2012 | ||||
| Estimated Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00894335 | ||||
| Other Study ID Numbers ICMJE | retroper adrenal | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Harald Groeben, Prof. Dr., Department of Anesthesiology and CCM , Clinics Essen-Mitte | ||||
| Study Sponsor ICMJE | Kliniken Essen-Mitte | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Kliniken Essen-Mitte | ||||
| Verification Date | May 2009 | ||||
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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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