Anesthesia Management of Retroperitoneal Adrenalectomies | NCT00894335

Studies
Anesthesia Management of Retroperitoneal Adrenalectomies

NCT00894335

Sponsor

Kliniken Essen-Mitte

Status

Unknown status

Last Update Posted

Jun 28, 2011Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Adrenal Tumors

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2008

Primary Completion Date

Mar 2012Estimated

Completion Date

Jul 2012Estimated

First Submitted Date

May 6, 2009

First Submission Date that Met QC Criteria

May 6, 2009

First Posted Date

May 7, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 27, 2011

Last Update Posted Date

Jun 28, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Pheochromocytoma
2		Conn-Syndrome
3		Cushing disease
4		Metastasis
5		Non-functional tumor

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Arterial-alveolar Carbon dioxide Difference		3 years

Secondary Outcomes

Measure	Description	Time Frame
Perioperative maximal mean arterial pressure		3 Years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with an adrenal tumor

Exclusion Criteria:

Age below 18 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with adrenal tumors scheduled for retroperitoneal adrenalectomies

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Harald Groeben, Prof., M.D.	Contact	##49 201 174	31109	h.groeben@kliniken-essen-mitte.de

Overall Officials

Name	Affiliation	Role
Harald Groeben, Prof, M.D.	Clinics Essen-Mitte	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinics Essen-Mitte	Recruiting	Essen		45136	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17188142	Background	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. doi: 10.1016/j.surg.2006.07.039.

ID	Term
D004701	Endocrine Gland Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D000307	Adrenal Gland Diseases