Condition category
Cancer
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
28/12/2006
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.rug.nl/umcg/index?lang=en

Funders

Funder type

Research organisation

Funder name

Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Netherlands Organisation for Health Research and Development

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes