search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


A randomized controlled trial of geriatric liaison intervention in frail surgical oncology patients.


- candidate number2334
- NTR NumberNTR823
- ISRCTNISRCTN46161863
- Date ISRCTN created28-dec-2006
- date ISRCTN requested18-dec-2006
- Date Registered NTR21-nov-2006
- Secondary IDsN/A 
- Public TitleA randomized controlled trial of geriatric liaison intervention in frail surgical oncology patients.
- Scientific TitleA randomized controlled trial of geriatric liaison intervention in frail surgical oncology patients.
- ACRONYMN/A
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studied
- Inclusion criteria1. A score greater than 3 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.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type[default]
- Studytypeintervention
- planned startdate 1-jan-2007
- planned closingdate1-jan-2010
- Target number of participants294
- InterventionsThe 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 mobilization 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 (Trzepazc 1998, 2001). To ensure uniformity of geriatric intervention in participating centres a daily checklist will be used.
- Primary outcomeThe cumulative incidence of delirium (measured with the Delirium Observation Scale and the DSM IV criteria) up to 10 days postoperatively.
- Secondary outcome1. Returning to the pre-operative living situation within 3 months postoperatively; 2. The Physical Component Summary measure (PCS) of the 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.
- Timepoints
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES B.L. Leeuwen, van
- CONTACT for SCIENTIFIC QUERIESProf. T. Wiggers
- Sponsor/Initiator University Medical Center Groningen (UMCG), Department of Surgery
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryRationale: It has been shown that a multicomponent intervention can decrease the occurrence of delirium in older patients (Inouye et al 1999). Geriatric liaison teams are well trained in implementing best-supportive care programs for elderly. In standard care geriatricians are not involved in pre-operative screening of patients and perioperative care and will only be consulted after major complications (delirium) or functional losses have occurred. Objective: 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. Study design: This is a multicenter prospective randomized clinical trial. Study population: Patients over 65 years of age admitted to the Department of Surgery of the participating centres for the surgical or combined cancer treatment (surgery / radiation /chemotherapy / hormonal therapy) of a solid tumor will be included in this study Intervention: The intervention entails participation of a geriatric nurse and geriatrician in the perioperative treatment of the oncogeriatric surgical patient. Main study parameters/endpoints: The main endpoint is the cumulative incidence of delirium (measured with the Delirium Observation Scale and the DSM IV criteria) up to 10 days postoperatively. Secondary endpoints are: returning to the pre-operative living situation within 3 months postoperatively,the Physical Component Summary measure (PCS) of the SF-36, the Mental Component Summary measure (MCS) of the SF-36, complications during hospital stay including mortality, care Dependence Scale at discharge. Direct health care and non-health care costs will be used as economic indicators Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The participating patients will have to complete 2 questionnaires at inclusion in the study which will take about 30 minutes in total. During their hospital stay they will be asked to complete several questionnaires which will take 15 minutes daily on average. Also 3 months postoperatively they will be asked to complete a questionnaire which takes 15-30 minutes on average. The Hb value will be taken from the routine blood samples and no extra blood samples or diagnostic tests will be performed on the participating patients unless their medical condition requires this (e.g. to rule out dehydration). Although changes in diet or medication may be made in the study group these are not expected to cause an extra burden or discomfort to the participating patients. No experimental drugs will be used during this study.
- Main changes (audit trail)
- RECORD21-nov-2006 - 29-apr-2008


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl