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BIG-5 study

The incidence and severity of the five most common complications in surgical patients: a prospective cohort study (BIG-5 study)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON23999
Enrollment
500
Registered
2020-12-08
Start date
2020-12-14
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None

Sponsors

Erasmus MC, University Medical Center Rotterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Patients aged = 16 years admitted to the nursing ward and will undergo or has undergone a surgical procedure including gastro-intestinal, hepatobiliary, pancreatic, endocrine, trauma, vascular, liver- and kidney- transplantation (both receiver and donor). - Sufficient knowledge of the Dutch language. - Communicable and able to assess the questionnaires. - Written informed consent is acquired from the patient.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Participation in another study that may possibly intervene with any of the outcome measures.

Design outcomes

Primary

MeasureTime frame
Anxiety using the State-Trait Anxiety Inventory (STAI-6) questionnaire, Subclinical stress using the Subclinical Stress Symptoms Questionnaire (SSQ-25), sleep quality using the adapted Dutch-Flemish Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance version 1.0 questionnaire, perioperative pain using the Numeric Rating Scale (NRS), postoperative risk for delirium using Delirium Observation Screening (DOS).

Secondary

MeasureTime frame
Daytime sleepiness using the Epworth Sleepiness Scale (ESS), physical parameters, complications during hospital stay, medication requirement, hospital length of stay, 30-day mortality.

Contacts

Public ContactRoos Geensen

Erasmus MC

r.geensen@erasmusmc.nl06-30310614

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)