PheochromocytomaCCAPNCT03158870
Surgeon-Anesthesiologist Collaboration
An observational study of Pheochromocytoma and Collaboration, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Collaboration between the surgeon and the anesthesiologist is key for delivering a safe pheochromocytoma surgery. This study aims to establish the collective performance of surgeon-anesthesiologist team by quantifying the relationship between their previous collaborations and patient complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pheochromocytoma, Collaboration
- What is being tested?
- Surgery complications
- Type of treatment
- Surgery or procedure
- How many people
- 1,122 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2017to Dec 2017
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Patients operated for pheochromocytoma
Who may be able to join
- All patients who underwent surgical procedure for pheochromocytoma in 8 French university hospitals from January 2000 to December 2016
Who cannot join
- Age < 18 years old
- Patients operated for incidentaloma or with paraganglioma diagnosis
Trial locations and contacts
1 site in 1 country.
France1 site
Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon - Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
About this study
Official title: Influence of Surgeon-anesthesiologist Collaboration on Patient Outcomes After Pheochromocytoma Surgery
Collaboration between the surgeon and the anesthesiologist is key for delivering a safe pheochromocytoma surgery. This study aims to establish the collective performance of surgeon-anesthesiologist team by quantifying the relationship between their previous collaborations and patient complications.
- Conditions
- Pheochromocytoma, Collaboration
- Being tested
- Surgery complications
- Medical subject headings
- Pheochromocytoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery complicationsProcedure or surgery
Assessment of the influence of surgeon-anesthesiologist collaboration on surgery complications during and up to 30 days after pheochromocytoma surgery.
| Study group | Role | What they receive |
|---|---|---|
| Pheochromocytoma | Patient who underwent surgical procedure for pheochromocytoma Receives: Procedure: Surgery complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of an intraoperative hemodynamic instability
An intraoperative hemodynamic instability is defined as the occurrence of at least one intraoperative episode of systolic blood pressure ≥ 160 mmHg and at least one episode of mean blood pressure ≤ 60 mmHg
Measured: At the time of surgery (less than 4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2017
- Study startJul 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PheochromocytomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 1,122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03158870
- Sponsor's protocol ID
- 69HCL17_0030
- Acronym
- CCAP
- Status last verified
- May 2017
- First submitted
- 17 May 2017
- Last updated
- 18 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Surgeon-anesthesiologist Collaboration on Patient Outcomes After Pheochromocytoma Surgery
- ClinicalTrials.gov ID
- NCT03158870
- Acronym / sponsor ID
- CCAP / 69HCL17_0030
- Conditions
- Pheochromocytoma, Collaboration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,122 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jul 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 18 May 2017 (actual)
- 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.
Collaboration between the surgeon and the anesthesiologist is key for delivering a safe pheochromocytoma surgery. This study aims to establish the collective performance of surgeon-anesthesiologist team by quantifying the relationship between their previous collaborations and patient complications.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pheochromocytoma | – | Procedure: Surgery complicationsPatient who underwent surgical procedure for pheochromocytoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients operated for pheochromocytoma
Key inclusion criteria (1 listed)
- All patients who underwent surgical procedure for pheochromocytoma in 8 French university hospitals from January 2000 to December 2016
Key exclusion criteria (2 listed)
- Age < 18 years old
- Patients operated for incidentaloma or with paraganglioma diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery complicationsAssessment of the influence of surgeon-anesthesiologist collaboration on surgery complications during and up to 30 days after pheochromocytoma surgery. | Procedure or surgery | Pheochromocytoma |
Primary outcome
Presence of an intraoperative hemodynamic instability
Time frame: At the time of surgery (less than 4 hours)
An intraoperative hemodynamic instability is defined as the occurrence of at least one intraoperative episode of systolic blood pressure ≥ 160 mmHg and at least one episode of mean blood pressure ≤ 60 mmHg
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2017.
- Individual participant dataSharing planned: No
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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.
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 Pheochromocytoma and Collaboration, run by Hospices Civils de Lyon at 1 site in France.
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 2 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 18 May 2017. 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 France. 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 Jean-Christophe LIFANTE, MD, PhD (04 78 56 90 95 ext. +33, jean-christophe.lifante@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of an intraoperative hemodynamic instability (time frame: At the time of surgery (less than 4 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2017.