Adrenal TumorsNCT00894335
Anesthesia Management of Retroperitoneal Adrenalectomies
An observational study of Adrenal Tumors, run by Kliniken Essen-Mitte at 1 site in Germany.
Trial summary
This study is a prospective, perioperative evaluation of hemodynamic and respiratory parameters in patients undergoing retroperitoneoscopic adrenalectomies. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Adrenal Tumors
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- May 2008to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with adrenal tumors scheduled for retroperitoneal adrenalectomies
Who may be able to join
- Patients with an adrenal tumor
Who cannot join
- Age below 18 years
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Clinics Essen-Mitte
Essen, 45136
Harald Groeben, Prof, M.D., ##49 201 174 ext. 31109, h.groeben@kliniken-essen-mitte.de
Harald Groeben, Prof, M.D., ##49 201 174 ext. 31109, h.groeben@klinken-essen-mitte.de
About this study
Official title: Anesthesiological Management of Hemodynamics and Gas Exchange for Retroperitoneal Adrenalectomies
This study is a prospective, perioperative evaluation of hemodynamic and respiratory parameters in patients undergoing retroperitoneoscopic adrenalectomies.
Read the 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.
- Conditions
- Adrenal Tumors
- Keywords
- retroperitoneoscopic adrenalectomy, intraoperative arterial-alveolar Carbon dioxide Difference
- Medical subject headings
- Adrenal Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Pheochromocytoma | |
| 2 | Conn-Syndrome | |
| 3 | Cushing disease | |
| 4 | Metastasis | |
| 5 | Non-functional tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial-alveolar Carbon dioxide Difference
Measured: 3 years
Secondary outcomes (1)
Perioperative maximal mean arterial pressure
Measured: 3 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2009 (estimated)
- Study startMay 2008
- Primary completionMar 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adrenal TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kliniken Essen-Mitte
- Sponsor type
- University, hospital or other
- Investigators
- Harald Groeben, Prof, M.D., Principal investigator, Clinics Essen-Mitte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00894335
- Sponsor's protocol ID
- retroper adrenal
- Status last verified
- May 2009
- First submitted
- 6 May 2009
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
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. doi: 10.1016/j.surg.2006.07.039.
PubMed 17188142
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anesthesiological Management of Hemodynamics and Gas Exchange for Retroperitoneal Adrenalectomies
- ClinicalTrials.gov ID
- NCT00894335
- Acronym / sponsor ID
- retroper adrenal
- Conditions
- Adrenal Tumors
- Keywords
- retroperitoneoscopic adrenalectomy, intraoperative arterial-alveolar Carbon dioxide Difference
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Kliniken Essen-MitteUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Mar 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 7 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Pheochromocytoma |
| 2 | – | –Conn-Syndrome |
| 3 | – | –Cushing disease |
| 4 | – | –Metastasis |
| 5 | – | –Non-functional tumor |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with adrenal tumors scheduled for retroperitoneal adrenalectomies
Key inclusion criteria (1 listed)
- Patients with an adrenal tumor
Key exclusion criteria (1 listed)
- Age below 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Arterial-alveolar Carbon dioxide Difference
Time frame: 3 years
1 secondary outcome
Perioperative maximal mean arterial pressure
Time frame: 3 Years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2011.
- Background: PubMed 17188142Walz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harald Groeben, Prof, M.D. principal investigator
Clinics Essen-Mitte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenal Tumors, run by Kliniken Essen-Mitte at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Harald Groeben, Prof., M.D. (##49 201 174 ext. 31109, h.groeben@kliniken-essen-mitte.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial-alveolar Carbon dioxide Difference (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00894335, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2011.