Perioperative Multimodal Care for Cystectomy Frail Patient

NCT03065348 | Terminated

• 1 other identifier: CARE-MAC Study
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Frail Elderly Syndrome; Bladder Disease; Nutrition Disorders; Cognitive Symptom

Keywords

prehabilitation; nutrition; hydration; cystectomy and urinary diversion; regional anesthesia; cognition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in CARE score

  from POD 7 to 14, 30 and 90

• Changes in cognition

  from baseline (before surgery) to Day 7 and Day 90

• Postoperative complication rate according to Clavien Dindo

  within the first 90 day after surgery

• Comprehensive complication index (CCI)

  within the first 90 day after surgery

Study Arms (1)

Intervention

EXPERIMENTAL

1. Around 2 to 4 weeks before surgery: * Fried frailty score * CARE score assessment * NRS Kondrup assessment * Plasma albumin and CRP values * Start with daily oral whey protein administration until evening before surgery45 2. Around 5-7 days before surgery: \- Start with immunonutrition 3. Evening before surgery: * CARE score assessment * NRS Kondrup * CERAD cognition test assessment * Plasma albumin and CRP values, urine specific gravity * Carbohydrate loading * If urine specific gravity is \>1.020 then additional tap water drinking will be encouraged 4. Day of surgery: * Carbohydrate loading * Start anesthesia with spinal anesthesia (continuous) 5. POD 7: * CARE assessment * CERAD assessment * Plasma albumin and CRP values 6. POD14: * CARE assessment * Plasma albumin and CRP value 7. POD 30: * CARE assessment * NRS Kondrup * CERAD assessment * Plasma albumin and CRP values 8. POD 90: * CARE assessment * NRS Kondrup * CERAD assessment

Dietary Supplement: oral whey protein; Dietary Supplement: Immunonutrition; Dietary Supplement: Carbohydrate Drink; Other: Preoperative hydration; Other: continous spinal anesthesia

Interventions

oral whey protein DIETARY_SUPPLEMENT

This substance is specifically formulated to target the nutritional needs of the elderly when they require increased energy and strength, such as following a fall or fracture or for the management of under nutrition and frailty. It provides 300 kcal, 20g of protein and increased levels of vitamin D, calcium. Available in vanilla, caramel and strawberry-biscuit

Also known as: Resource Whey Protein, Nestlé Health Schweiz

Intervention

Immunonutrition DIETARY_SUPPLEMENT

This substance is a clinically proven nutritional solution for the dietary management of major elective surgery patients, to improve clinical outcomes, and reduce postoperative complications and length of hospital stay. IMPACT formulation contains omega-3 fatty acids, arginine and nucleotides, and is suitable for use as a sole source of nutrition. Oral IMPACT is a powdered sip feed that provides 303kcal per portion when reconstituted with water (74g powder plus 250ml water) and is enriched with omega-3 fatty acids, arginine, nucleotide, 3 gr of soluble fibre 321mg sodium, 402 mg potassium, 216 mg phosphate per portion.

Also known as: Oral Impact, Nestlé Health Schweiz

Intervention

Carbohydrate Drink DIETARY_SUPPLEMENT

Resource® preload™ contains the following elements: Per portion à 50gr 47.5 gr carbohydrate, \< 10mg sodium, 190kcal

Also known as: Resource Preload Nestlé Health Schweiz

Intervention

Preoperative hydration OTHER

If urine specific gravity is \>1.020 then additional tap water drinking will be encouraged (1% of ideal body weight)

Intervention

continous spinal anesthesia OTHER

Surgery will be performed under continuous spinal anesthesia without general anesthesia

Intervention

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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)

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

University Hospital Inselspital

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Urinary Bladder Diseases; Nutrition Disorders; Neurobehavioral Manifestations

Interventions

Whey Proteins; Immunonutrition Diet

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nutritional and Metabolic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk Proteins; Animal Proteins, Dietary; Dietary Proteins; Proteins; Amino Acids, Peptides, and Proteins; Whey; Milk; Dairy Products; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Diet; Nutritional Physiological Phenomena

Study Officials

• Patrick Wuethrich, MD

  Insel Gruppe AG, University Hospital Bern

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: First step: pilot study including 20 patients (intervention ) Second step: inclusion of 11 additional patients. Comparison of the intervention group (n=31) with a historical similar population (control group, n=31)

Study Record Dates

• First Submitted: February 17, 2017
• First Posted: February 27, 2017
• Study Start: April 6, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: April 10, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)