Pheochromocytoma and Hemodynamic Instability

Risk Factors for Hemodynamic Instability During Laparoscopic Pheochromocytoma Resection - Single Centre Experience

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Surgery; Pheochromocytoma
• Intervention / Treatment: Procedure: Laparoscopic adrenalectomy

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 96

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with histologically confirmed pheochromocytoma undergoing laparoscopic adrenalectomy

Description

Inclusion Criteria:

• patients with histologically confirmed pheochromocytoma undergoing laparoscopic adrenalectomy

Exclusion Criteria:

• bilateral tumour
• no histopathological result
• neoplastic spread

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Hemodynamic Instability (n, %)	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.	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Complications in Patients (n, %)	Data on morbidity were classified according to the Clavien-Dindo classification.	Within 30 days after surgery
Number of Cardiovascular Complications in Patients (n, %)	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.	Within 30 days after surgery

Other Outcome Measures

Outcome Measure	Time Frame
Length of hospital stay (days)	Up to 30 days
Duration of anaesthesia (min)	Intraoperative
Duration of surgery (min)	Intraoperative
Patients needing blood transfusion, n (%)	Intraoperative
Mean intraoperative blood loss (ml)	Intraoperative
Number of participants who required intraoperative vasodilators administration (n, %)	Intraoperative
Number of participants who required intraoperative vasopressors administration (n, %)	Intraoperative
Patients with episodes systolic blood pressure >200 mmHg (n, %)	Intraoperative
Patients with episodes systolic blood pressure >180 mmHg (n, %)	Intraoperative
Patients with episodes systolic blood pressure >160 mmHg (n, %)	Intraoperative
Number of participants who required postoperative vasopressorss administration (n, %)	Within 24 hours after surgery

Collaborators and Investigators

• Sponsor: Jagiellonian University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2003
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: September 17, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2020
• Last Update Submitted That Met QC Criteria: September 22, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: surgery; laparoscopy; pheochromocytoma; haemodynamics
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Paraganglioma; Pheochromocytoma
• Other Study ID Numbers: Pheochromocytoma&HI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No