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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00894335
Other study ID # retroper adrenal
Secondary ID
Status Recruiting
Phase N/A
First received May 6, 2009
Last updated June 27, 2011
Start date May 2008
Est. completion date July 2012

Study information

Verified date May 2009
Source Kliniken Essen-Mitte
Contact Harald Groeben, Prof., M.D.
Phone ##49 201 174
Email h.groeben@kliniken-essen-mitte.de
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial Summary

This study is a prospective, perioperative evaluation of hemodynamic and respiratory parameters in patients undergoing retroperitoneoscopic adrenalectomies.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date July 2012
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Patients with an adrenal tumor

Exclusion Criteria:

- Age below 18 years

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Clinics Essen-Mitte Essen

Sponsors (1)

Lead Sponsor Collaborator
Kliniken Essen-Mitte

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Arterial-alveolar Carbon dioxide Difference 3 years No
Secondary Perioperative maximal mean arterial pressure 3 Years No
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