|- candidate number||4635|
|- NTR Number||NTR1567|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||28-nov-2008|
|- Secondary IDs|| |
|- Public Title||Preoperative risk estimation for onco-geriatric patients.|
|- Scientific Title||A clinical trial for the comparison of different preoperative assessment tools in the elderly surgical patient.|
|- hypothesis||This study will be performed to test the predictive value of the GFI, the VES-13 and the timed “up and go” test compared to components of PACE in elderly patients of the age of 70 years and above undergoing surgery for a solid tumour. |
|- Healt Condition(s) or Problem(s) studied||Older adults, Risk factors, Onco-geriatric patients|
|- Inclusion criteria||- Patients aged >70 years undergoing elective surgery for a solid tumour under general anaesthesia will be included for this study. |
- Patients will be stratified according to tumour localisation: intra cavity (e.g. colorectal, gynaecological) vs superficial (e.g. breast, head & neck, melanoma).
|- Exclusion criteria||- Patients not able to give informed consent|
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-sep-2008|
|- planned closingdate||1-mei-2010|
|- Target number of participants||362|
|- Interventions||The combination of components of PACE, the timed “up and go” test, the VES-13 and the GFI will be administered to every patient within two weeks prior to the surgical procedure. This can be done by a nurse in the preoperative clinic and will take approximately 30 minutes.
Patient data will be recorded during the length of the hospital stay, the patient file will be used to retrieve these data.
- medication used
- living situation
- nutritional status.
- type of surgery
- duration of anaesthesia
- blood loss
- length of hospital stay
- postoperative complications
- consultation by other specialist.
Follow up: at the postoperative visit to the outpatient clinic additional data on morbidity occurring during the first 30 days postoperatively can be recorded as well as any additional specialists that were involved in patient care in the first 30 postoperative days.
|- Primary outcome||- Primary endpoint will be 30 day morbidity and mortality.|
|- Secondary outcome||- Secondary endpoints will be length of hospital stay and the number of additional specialists involved in patient care in the 30 days after surgery. |
|- Timepoints||Data will be collected preoperatively and up to 30 days postoperatively|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| B.L. Leeuwen, van|
|- CONTACT for SCIENTIFIC QUERIES|| B.L. Leeuwen, van|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG), Department of Surgery|
(Source(s) of Monetary or Material Support)
|University Medical Center Groningen (UMCG)|
|- Brief summary||-|
|- Main changes (audit trail)|
|- RECORD||28-nov-2008 - 8-dec-2008|