Perioperative Multimodal Care for Cystectomy Frail Patient

NCT03065348 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2019-04-10

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Immunonutrition

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.

DIETARY_SUPPLEMENT

Carbohydrate Drink

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

OTHER

Preoperative hydration

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

OTHER

continous spinal anesthesia

Surgery will be performed under continuous spinal anesthesia without general anesthesia

DIETARY_SUPPLEMENT

oral whey protein

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

Sponsors & Collaborators

  • Insel Gruppe AG, University Hospital Bern

    lead OTHER

Principal Investigators

  • Patrick Wuethrich, MD · Insel Gruppe AG, University Hospital Bern

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-06
Primary Completion
2019-03-01
Completion
2019-03-01

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03065348 on ClinicalTrials.gov