NCT03158870

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,122

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

May 18, 2017

Status Verified

May 1, 2017

Enrollment Period

5 months

First QC Date

May 17, 2017

Last Update Submit

May 17, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    At the time of surgery (less than 4 hours)

Study Arms (1)

Pheochromocytoma

Patient who underwent surgical procedure for pheochromocytoma

Procedure: Surgery complications

Interventions

Assessment of the influence of surgeon-anesthesiologist collaboration on surgery complications during and up to 30 days after pheochromocytoma surgery.

Pheochromocytoma

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients operated for pheochromocytoma

You may qualify if:

  • All patients who underwent surgical procedure for pheochromocytoma in 8 French university hospitals from January 2000 to December 2016

You may not qualify if:

  • Age \< 18 years old
  • Patients operated for incidentaloma or with paraganglioma diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pôle Information Médicale Evaluation Recherche des Hospices Civils de Lyon - Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Pheochromocytoma

Condition Hierarchy (Ancestors)

ParagangliomaNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Central Study Contacts

Jean-Christophe LIFANTE, MD, PhD

CONTACT

Antoine DUCLOS, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2017

First Posted

May 18, 2017

Study Start

July 1, 2017

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

May 18, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations