Frail Elderly Syndrome Clinical Trial
Official title:
A Multimodal Pre- and Intraoperative Approach for Frail Cystectomy Patients. A Prospective Single-arm Matched Case Feasibility Study
Verified date | April 2019 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Major surgery in the elderly and frail patient is a challenge. Optimal perioperative
management is essential for outcome and survival. There is a need for improved
multidisciplinary approach to improve postoperative outcome in this patient population at
high risk for postoperative morbidity and mortality. Here the investigators will evaluate the
implementation of a multimodal prehabilitation program including optimization of nutrition
(protein and carbohydrate loading), optimization of preoperative hydration and the use of
regional anesthesia during cystectomy and urinary diversion in a series old frail patients
and compared/matched them to a historical series of similar patients in terms of early return
of quality of life using the Convalescence and Recovery Evaluation (CARE) instrument,
cognition, and postoperative morbidity.
The importance of patient-reported health status is well recognized and is a facet of
healthcare quality. In addition it is a valuable means for quantitatively measuring the
implication of technology adoption for the patient, who typically judges the efficacy of a
surgical procedure by whether it improves quality of life.
The objective of this study is to evaluate the implementation of a multimodal prehabilitation
program in a series old frail patients and compared them to a historical series of similar
frail patients in terms of early return of quality of life, cognition, and postoperative
morbidity. The importance of patient-reported health status is well recognized and is a facet
of healthcare quality. In addition it is a valuable means for quantitatively measuring the
implication of technology adoption for the patient, who typically judges the efficacy of a
surgical procedure by whether it improves quality of life.
Status | Terminated |
Enrollment | 4 |
Est. completion date | March 1, 2019 |
Est. primary completion date | March 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 75 Years and older |
Eligibility |
Inclusion Criteria: - Informed Consent as documented by signature (Appendix Informed Consent Form) - = 75 years old - Fried frailty score =2 - Cystectomy with urinary diversion - No contra-indication for spinal or epidural anesthesia Exclusion Criteria: - Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product, - Women who are pregnant or breast feeding (not applicable as recruitment concerns patients with =75 yrs of age) - Known or suspected non-compliance, drug or alcohol abuse, - Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant, - Enrolment of the investigator, his/her family members, employees and other dependent persons, - Specific exclusions for the disease under study, - Specific concomitant therapy washout requirements prior to and/or during study participation, - Dietary restrictions: milk allergy - Refusal to regional anesthesia - Risk of aspiration - Oral fluid restriction due to any reasons (severe renal insufficiency i.e. GFR < 20ml/min) |
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Inselspital | Bern |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in CARE score | The CARE score is a robust multi-dimensional measure of convalescence after major abdominal and pelvic surgery. The CARE instrument covers 4 domains (pain, gastrointestinal, cognition and activity). The CARE score has been specifically designed and validated for patients undergoing abdominal and pelvic surgery (like cystectomy) with a high test retest reliability ranging from 0.78 to >0.88. The importance of patient-reported health status is well recognized and is a facet of healthcare quality. In addition it is a valuable means for quantitatively measuring the implication of medical treatment for the patient, who typically judges the efficacy of a surgical procedure by whether it improves quality of life | baseline before surgery to postoperative day (POD) 7 | |
Secondary | Change in CARE score | see above | from POD 7 to 14, 30 and 90 | |
Secondary | Changes in cognition | CERAD test performance: The Consortium of Establish a Registry for Alzheimer's Disease (CERAD) test is a widely validated test packet for evaluation of old patients with dementia. However this CERAD test has also been validated in the perioperative setting. It consists of a test battery, including verbal fluency, Boston naming test, word list learning, constructional praxis, word list recall, word list recognition, and mini mental state examination, which can detect subtle changes in cognition. It is easy applicable and the investigators have expertise using this test in a similar cystectomy population. |
from baseline (before surgery) to Day 7 and Day 90 | |
Secondary | Postoperative complication rate according to Clavien Dindo | Clavien Dindo complications: This is the most widely used classification system for postoperative complications, and is well established in cystectomy patients. An additional more sensitive index has been recently been introduced called Complication Comprehensive Index (CCI) to measure surgical morbidity . |
within the first 90 day after surgery | |
Secondary | Comprehensive complication index (CCI) | An additional more sensitive index has been recently been introduced called Complication Comprehensive Index (CCI) to measure surgical morbidity . | within the first 90 day after surgery |
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