Genetic Variants and Perioperative Morbidity and Mortality
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Anesthesia, Analgesia, Surgical Procedure, Operative. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Primary outcome measures
- Postoperative nausea and vomiting (PONV) [Time frame: Up to 48 hours after surgery]
Secondary outcome measures (5)
- Pain related impairment after surgery [Time frame: up to 2 days after surgery]
- Pain related impairment of patients with chronic pain after surgery versus patients without chronic pain after surgery [Time frame: up to one year after surgery]
- Cardio-vascular events after surgery [Time frame: Up to 30 days after surgery]
- Pain related impairment of patients with chronic neuropathic pain (DN4 positive) after surgery versus patients without neuropathic pain after surgery [Time frame: up to one year after surgery]
- What influences pain related impairment after bariatric surgery [Time frame: up to 1 year after surgery]
Eligibility criteria
Inclusion criteria
- 18 years and older
- Written informed consent
- Scheduled surgery
Exclusion criteria
- No informed consent
- Cognitive impairment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Switzerland · 1 center
- Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern — Bern
Identifiers
NCT: NCT02124499 · 041/09