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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02124499
Other study ID # 041/09
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 2011
Est. completion date June 2026

Study information

Verified date May 2024
Source Insel Gruppe AG, University Hospital Bern
Contact Ulrike M Stamer, Prof. MD
Phone 0041-316329995
Email ulrike.stamer@dbmr.unibe.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20000
Est. completion date June 2026
Est. primary completion date March 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years and older - Written informed consent - Scheduled surgery Exclusion Criteria - No informed consent - Cognitive impairment

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland Department of Anaesthesiology and Pain Medicine, Inselspital, University of Bern Bern

Sponsors (1)

Lead Sponsor Collaborator
Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative nausea and vomiting (PONV) 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 Up to 48 hours after surgery
Secondary Pain related impairment after surgery Measured by the International Pain Outcomes Questionnaire up to 2 days after surgery
Secondary Pain related impairment of patients with chronic pain after surgery versus patients without chronic pain after surgery Measured by the Brief Pain Inventory (BPI) up to one year after surgery
Secondary Cardio-vascular events after surgery Measured by a score for major adverse cardiac events (MACE) Up to 30 days after surgery
Secondary Pain related impairment of patients with chronic neuropathic pain (DN4 positive) after surgery versus patients without neuropathic pain after surgery Measured by the Brief Pain Inventory (BPI) up to one year after surgery
Secondary What influences pain related impairment after bariatric surgery Measurement of patient reported outcome by the BPI (Brief Pain Inventory). up to 1 year after surgery
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