Genetic Variants and Perioperative Morbidity and Mortality

NCT ID: NCT02124499

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-02

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Anesthesia Analgesia Surgical Procedure, Operative

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All patients

Patients undergoing elective surgery with anesthesia

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 18 years and older
* Written informed consent
* Scheduled surgery

Exclusion Criteria

* No informed consent
* Cognitive impairment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frank Stüber, Prof. MD

Role: STUDY_CHAIR

Department of Anaestheisolpogy + Pain Medicine, Inselspital, University of Bern

Ulrike M Stamer, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern

Locations

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Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern

Bern, , Switzerland

Site Status RECRUITING

Countries

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Switzerland

Central Contacts

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Ulrike M Stamer, Prof. MD

Role: CONTACT

0041-316329995

Markus Lüdi, MD

Role: CONTACT

0041-316323965

Facility Contacts

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Frank Stüber, Professor MD

Role: primary

041-316322483

Anneliese Hoffmann, PhD

Role: backup

0041-316328872

Other Identifiers

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041/09

Identifier Type: -

Identifier Source: org_study_id

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