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Trial Title:
Intraoperative Hemodynamic Instability During Unilateral Adrenalectomy for Pheochromocytoma
NCT ID:
NCT06062082
Condition:
Pheochromocytoma
Non-Secretory Adrenal Adenoma
Conditions: Official terms:
Adenoma
Pheochromocytoma
Adrenocortical Adenoma
Conditions: Keywords:
adrenalectomy
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Procedure
Intervention name:
adrenalectomy
Description:
laparoscopic exeresis of the adrenal gland
Arm group label:
Control
Arm group label:
Pheochromocytoma
Summary:
Pheochromocytomas are tumors of the adrenal gland that develop from cells producing
adrenaline and noradrenaline. Consequently, intraoperative blood pressure variations
(hypertensive and hypotensive episodes) are characteristic of pheochromocytoma surgery,
when these tumors are removed. However, recommendations for the management of these
tumors are based on data essentially dating from the 1960s-1990s. Since then, anesthesia
and surgery for patients with pheochromocytoma have evolved considerably, and have become
more effective with time. In these circumstances, a review of the current situation is
necessary. The aim of this study is to investigate the intraoperative hemodynamic changes
observed in patients undergoing adrenalectomy for pheochromocytoma, comparing them with
the hemodynamic profile observed in patients undergoing adrenal surgery for a pathology
other than pheochromocytoma (control group).
Detailed description:
Each patient included in this study underwent unilateral adrenalectomy for adrenal
pathology during the inclusion period. For each patient included, intraoperative
hemodynamic data were collected every 20 seconds by the monitoring system used by the
anesthesia team (VitalSignsCapture v1.004 program via RS232 port). For each patient, the
HI score (a clinical tool validated in two previously published articles) was calculated
for the intraoperative period (time between induction of anesthesia and patient discharge
from the operating room). This enabled a comparison to be made between patients operated
on for pheochromocytoma (30 patients) and patients operated on for a cause other than
pheochromocytoma (30 patients).
Criteria for eligibility:
Study pop:
Patients operated on for unilateral adrenal pathology by laparosocopic approach
(pheochromocytoma and non-pheochromocytoma) in the department of gastrointestinal,
metabolic and cancer surgery (CVMC, CHU Nancy)
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
- Patients operated on for unilateral adrenal pathology by laparosocopic approach
(pheochromocytoma and non-pheochromocytoma)
Exclusion Criteria:
- Patients operated on for unilateral adrenal pathology by laparosocopic approach
(pheochromocytoma and non-pheochromocytoma)
- Patients operated on for bilateral adrenal pathology
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
CHRU Nancy - Département Chirurgie Viscérale, Métabolique et Cancérologique CVMC (7ème étage)
Address:
City:
Nancy
Zip:
54511
Country:
France
Status:
Recruiting
Contact:
Last name:
Laurent Brunaud
Start date:
September 1, 2015
Completion date:
September 1, 2024
Lead sponsor:
Agency:
Central Hospital, Nancy, France
Agency class:
Other
Source:
Central Hospital, Nancy, France
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06062082