Infectious ComplicationsNCT05244655
Early Postoperative Pain and 30-day Complications Following Major Abdominal Surgery: an Observational Study
An observational study of Infectious Complications and Postoperative Pain, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infectious Complications, Postoperative Pain, Acute Pain
- How many people
- 1,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Dec 2021to 8 Dec 2023
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- Major abdominal surgery under general anesthesia
Who cannot join
- younger than 18 years of age
- procedures outside the operation room
- procedures solely under regional anesthesia, i.e. no general anesthesia
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Infectious Complications, Postoperative Pain, Acute Pain, Postoperative Complications, Surgery--Complications
- Keywords
- Early postoperative pain, Infectious complications
- Medical subject headings
- Pain, Postoperative, Acute Pain, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients without painscores available during hospital stay | Not described | |
| Patients with painscores available during hospital stay | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute postoperative pain
Early pain following abdominal surgery POD1
Measured: 1 day
Secondary outcomes (2)
Infectious complications postoperative
within 30 days
Measured: 30 days
Overall complications postoperative
within 30 days
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start1 Dec 2021
- Primary completion3 Jan 2022
- Study completion8 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infectious ComplicationsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05244655
- Sponsor's protocol ID
- CORE-1
- Status last verified
- Nov 2021
- First submitted
- 8 Feb 2022
- Last updated
- 4 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 39957489
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Postoperative Pain and 30-day Complications Following Major Abdominal Surgery: an Observational Study
- ClinicalTrials.gov ID
- NCT05244655
- Acronym / sponsor ID
- CORE-1
- Conditions
- Infectious Complications, Postoperative Pain, Acute Pain, Postoperative Complications, Surgery--Complications
- Keywords
- Early postoperative pain, Infectious complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 3 Jan 2022 (actual)
- Study completion
- 8 Dec 2023 (actual)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients without painscores available during hospital stay | – | – |
| Patients with painscores available during hospital stay | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (1 listed)
- Major abdominal surgery under general anesthesia
Key exclusion criteria (3 listed)
- younger than 18 years of age
- procedures outside the operation room
- procedures solely under regional anesthesia, i.e. no general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Acute postoperative pain
Time frame: 1 day
Early pain following abdominal surgery POD1
2 secondary outcomes
Infectious complications postoperative
Time frame: 30 days
Overall complications postoperative
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2024.
- Derived from this study: PubMed 39957489Bijkerk 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infectious Complications and Postoperative Pain, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute postoperative pain (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05244655, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2024.