Early Postoperative Pain and 30-day Complications Followi... | NCT05244655

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

NCT05244655

Sponsor

Radboud University Medical Center

Status

Completed

Last Update Posted

Apr 4, 2024Actual

Enrollment

1,000Actual

Phase

Not provided

Conditions

Infectious Complications
Postoperative Pain
Acute Pain
Postoperative Complications
Surgery--Complications

Interventions

Not provided

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2021Actual

Primary Completion Date

Jan 3, 2022Actual

Completion Date

Dec 8, 2023Actual

First Submitted Date

Feb 8, 2022

First Submission Date that Met QC Criteria

Feb 8, 2022

First Posted Date

Feb 17, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2024

Last Update Posted Date

Apr 4, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

30 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acute postoperative pain	Early pain following abdominal surgery POD1	1 day

Secondary Outcomes

Measure	Description	Time Frame
Infectious complications postoperative	within 30 days	30 days
Overall complications postoperative	within 30 days	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

All patients who underwent major abdominal surgery, mostly electively scheduled, between January 2014 and December 2020 were considered eligible for participation in our study.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
RadboudUMC		Nijmegen	Gelderland		Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39957489	Derived	Bijkerk V, Jacobs LMC, Visser J, van Helden EV, Keijzer C, Helder LS, Albers KI, Warle MC. The immunomodulatory effect of sugammadex in vitro and after total hip arthroplasty : A randomised controlled pilot and retrospective cohort study. Eur J Anaesthesiol. 2025 Aug 1;42(8):676-686. doi: 10.1097/EJA.0000000000002132. Epub 2025 Feb 14.

Label	Type	Description	Intervention Names
Patients without painscores available during hospital stay
Patients with painscores available during hospital stay

ID	Term
D010149	Pain, Postoperative
D059787	Acute Pain
D011183	Postoperative Complications

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain
D009461	Neurologic Manifestations