Contact information
Type
Scientific
Primary contact
Dr B L van Leeuwen
ORCID ID
Contact details
University Medical Center Groningen (UMCG)
Department of Surgery
P.O. Box 30001
Groningen
9700 RB
Netherlands
+31 (0)50 361 2301
blvleeuwen@hetnet
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
The primary objective of this study is to show that early detection of geriatric patients at risk of preventable functional decline following a surgical procedure under general anesthesia for a solid tumor, combined with a geriatric liaison intervention will decrease the occurrence of delirium and consequent morbidity and mortality, without an increase in costs.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, controlled, parallel group, multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Frail surgical oncology geriatric patients
Intervention
The intervention entails participation of a geriatric nurse and geriatrician in the perioperative treatment of the oncogeriatric surgical patient. Multi-component interventions to achieve best-supportive care in individual treatment plans will be implemented. These will be focused on electrolyte- and fluid levels, pain management, pharmacological clearance, miction and defecation, nutrition, early mobilisation and rehabilitation, sleep, vision, hearing and cognition.
The Delirium Observation Scale (DOS) will be used to screen for delirium by the nurse and the Delirium Rating Scale (DRS) will be used to measure the severity of the delirium. To ensure uniformity of geriatric intervention in participating centres a daily checklist will be used.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
The cumulative incidence of delirium (measured with the Delirium Observation Scale and the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition [DSM IV] criteria) up to ten days postoperatively.
Secondary outcome measures
1. Returning to the pre-operative living situation within 3 months postoperatively
2. The Physical Component Summary measure (PCS) of the Short Form health survey (SF-36)
3. The Mental Component Summary measure (MCS) of the SF-36
4. Complications during hospital stay including mortality
5. Care Dependence Scale at discharge
6. Direct health care and non-health care costs will be used as economic indicators
Overall trial start date
01/01/2007
Overall trial end date
01/01/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. A score greater than three on the Groningen Frailty Index (GFI)
2. Surgery is scheduled more than 24 hours after inclusion in the study as we feel this is the time necessary for the geriatric team to plan their perioperative measures
3. Surgery under general anesthesia
4. Written informed consent given according to local regulations
Participant type
Patient
Age group
Senior
Gender
Not Specified
Target number of participants
294
Participant exclusion criteria
1. Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
2. Patient unable to comply with the outcome questionnaires
Recruitment start date
01/01/2007
Recruitment end date
01/01/2010
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Center Groningen (UMCG)
Groningen
9700 RB
Netherlands
Sponsor information
Organisation
University Medical Center Groningen (UMCG) (The Netherlands)
Sponsor details
Department of Surgery
P.O. Box 30.001
Groningen
9700 RB
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
Funder name
Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list