No registrations found.
ID
Source
Brief title
Health condition
Surgery patients
Sponsors and support
Intervention
Outcome measures
Primary outcome
- 30-day incidence of major (Clavien-dindo classification lll, lV and V) postoperative complications (including mortality)
Secondary outcome
- 30-day incidence of minor (Clavien-dindo classification l and ll) postoperative complications
- length of stay (LOS) (hospital, medium care, intensive care)
- one-year mortality
- 30-day and one-year quality of life
Background summary
We aim to prospectively follow surgical patients during the upscaling phase in Dutch hospitals, and compare this new cohort with the control cohort from the TRACE study.
Study objective
We hypothesize that surgical patients in the new cohort have poorer health conditions prior to surgery and poorer health outcomes post-surgically compared to the control cohort (TRACE study)
Study design
Pre-operative, intra-operative, post-operative, 30 day and 1 year post-operatively
Intervention
None
Inclusion criteria
All adult (18 years and older) patients undergoing elective surgery, with an indication for postoperative hospital stay, and meeting at least one of the following criteria:
- indication of postoperative pain therapy with follow up by Acute Pain Service
- ≥60 years
- ≥45 years and a revised Cardiac Risk Index (rCRI) > 2
- surgical APGAR score (sAPGAR) <5 (patients not fulfilling this and any other criterion will be excluded after surgery)
Exclusion criteria
- Patients who do not sign informed consent
- Patients who are not able to complete the questionnaires in the Dutch language
- Pregnancy and caesarean sectio
- Fractures, appendectomy, organ transplant (donor)
- Screening failures: Patients who completed both questions “Was uw operatie uitgesteld tijdens de coronacrisis?” and “Denkt u dat het inplannen van uw operatie vertraging heeft opgelopen tijdens de coronacrisis?” with “No”.
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8841 |
| Other | METC Amsterdam UMC, location AMC : W20_384 # 20.429 (reference non-WMO confirmation) |