Pheochromocytoma and Hemodynamic Instability

Completed

• Conditions: Pheochromocytoma; Surgery; Hypertension

• Registration Number: NCT04566406
• Lead Sponsor: Jagiellonian University

Brief Summary

The aims of our study were to define perioperative HI during laparoscopic adrenalectomy for pheochromocytoma, assess the incidence of perioperative HI, and identify predictive factors of perioperative HI in our group of patients.

Detailed Description

The study was a retrospective observation of consecutive patients with histologically confirmed pheochromocytoma undergoing laparoscopic adrenalectomy between years 2003 and 2019.

Study Timeline

• Study Start: 2003-01
• Primary Completion: 2019-12
• Status Verified: 2020-09
• Study Completion: 2020-09
• Study First Submitted: 2020-09-17
• Study First Submitted QC: 2020-09-22
• Last Update Submitted: 2020-09-22
• Study First Posted: 2020-09-28
• Last Update Posted: 2020-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• patients with histologically confirmed pheochromocytoma undergoing laparoscopic adrenalectomy

Exclusion Criteria

• bilateral tumour
• no histopathological result
• neoplastic spread

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Participants with Hemodynamic Instability (n, %)	intraoperative	Hemodynamic instability was defined as an occurrence of both intraoperative episodes of systolic blood pressure above 160 mm Hg and vasoactive (vasodilators or vasoconstrictors) drugs administration. Patients were divided into two groups: one which met both above criteria, and another one without hemodynamic instability.

Secondary Outcome Measures

Name	Time	Method
Number of Complications in Patients (n, %)	Within 30 days after surgery	Data on morbidity were classified according to the Clavien-Dindo classification.
Number of Cardiovascular Complications in Patients (n, %)	Within 30 days after surgery	Cardiovascular morbidity was defined as postoperative morbidity related to the cardiovascular system: postoperative hypotensive or hypertensive episodes requiring pharmacologic treatment, need for blood transfusion, myocardial or digestive ischemia, stroke, and postoperative hospitalization in intensive care unit (ICU) for cardiac-related causes.