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NCT05244655 Clinical Trial

Early Postoperative Pain and 30-day Complications Following Major Abdominal Surgery: an Observational Study

Postoperative Pain Clinical Trial

Official title:
Early Postoperative Pain and 30-day Complications Following Major Abdominal Surgery: an Observational Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05244655
Other study ID # CORE-1
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2021
Est. completion date December 8, 2023

Study information
Verified date November 2021
Source Radboud University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

In this retrospective cohort study, we assess the relationship between the intensity of early postoperative pain and the risk of infectious- and non-infectious complications within 30 days after major abdominal surgery.

Recruitment information / eligibility
Status Completed
Enrollment 1000
Est. completion date December 8, 2023
Est. primary completion date January 3, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Major abdominal surgery under general anesthesia Exclusion Criteria: - younger than 18 years of age - procedures outside the operation room - procedures solely under regional anesthesia, i.e. no general anesthesia

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Netherlands RadboudUMC Nijmegen Gelderland

Sponsors (1)
Lead Sponsor Collaborator
Radboud University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary Acute postoperative pain Early pain following abdominal surgery POD1 1 day
Secondary Infectious complications postoperative within 30 days 30 days
Secondary Overall complications postoperative within 30 days 30 days
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