NCT Number: NCT02124499
Prospective association study to analyse perioperative patients' outcome. Outcome comprises intraoperative and postoperative complications e.g. cardio-vascular events, allergic reactions, Possible variables which might have on influence: patient- and surgery-related data, patients' genetic background etc.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Bern, 3010, Switzerland
Location status: Recruiting
Anneliese Hoffmann, PhD
CONTACT
Frank Stüber, Professor MD
CONTACT
Ulrike M Stamer, MD
SUB_INVESTIGATOR
Background Anesthesia and surgery are related to unwanted adverse events, side effects and postoperative discomfort. Whereas severe complications like cardiovascular events are rare, postoperative side effects like nausea and vomiting, pain, long-lasting pain and pain related interference of daily activities are frequent. The question arises which patient is at specific risk for this sequelae. Pre-exiting predisposing factors (e.g. patients' genetic background), surgery and anesthesia related variables (drugs, techniques administered for anesthesia and analgesia) as well as psychological and social factors might influence the outcome.
In this prospective association study these variables will be investigated in a well-described patient cohort presenting for elective surgery.
Objective
The aim of this study is to associate perioperative and postoperative complications and side effects as well as long-term outcome after surgery to patient- and surgery-related variables, including genetic variants.
Methods
Prospective association study performed in two independent patient cohorts.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Up to 48 hours after surgery
Percent of patients with no PONV, medium PONV and severe PONV PONV outcome measured by a composite score: number of episodes of vomiting + severity of nausea (NRS score) + need for antiemetic treatment Patients with no PONV are compared to those with intermediate and severe PONV
Time frame: up to 2 days after surgery
Measured by the International Pain Outcomes Questionnaire
Time frame: up to one year after surgery
Measured by the Brief Pain Inventory (BPI)
Time frame: Up to 30 days after surgery
Measured by a score for major adverse cardiac events (MACE)
Time frame: up to one year after surgery
Measured by the Brief Pain Inventory (BPI)
Time frame: up to 1 year after surgery
Measurement of patient reported outcome by the BPI (Brief Pain Inventory).
Contact information is provided by the study sponsor or research team.
Markus Lüdi, MD
CONTACT
Ulrike M Stamer, Prof. MD
CONTACT
Insel Gruppe AG, University Hospital Bern
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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