Patient Empowerment for Major Surgery Preparation @ Home

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

26 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2024-03-31

Brief Summary

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The PAPRIKA project is a feasibility study with duration of 10 months. The aim of the study is to recruit 25 patients over the age of 65 who will undergo tumor-related esophagectomy and will follow a prehabilitation program to prevent postoperative complications and improve patient-centric complications and patient-centered outcomes.

After determination of the oncologic treatment plan in the tumor board and functional assessment, patient will undergo an interdisciplinary assessment , which will be performed by the PAPRIKA team consisting of physiotherapists, internists/geriatricians, speech and occupational therapists, nutritionists and surgeons.

On the basis of this interdisciplinary assessment an individualized catalog of procedures will be created. Patient have to follow to this catalog of procedures until surgery. Procedures catalog contains behavioral changes, physical training, nutritional counseling, conditioning of pulmonary function and optimization of drug treatment of underlying diseases.

The individual treatments will be weekly reevaluated and if necessary the procedures will be adjusted by treatment teams.

The prehabilitation procedures will be communicated with the patient via a smartphone app, which is specially developed for the prehabilitation program. The implementation will be documented.

The primary aim of this study is to evaluate the compliance of the patients regarding to the prescribed procedures and the use of the smartphone app (feasibility).

As secondary aim postoperative outcome will be compared with the results of a historical cohort for quality control.

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Detailed Description

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Conditions

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Transthoracic Esophagectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Prehabilitation

25 patients scheduled for tumor-esophagectomy (Ivor-Lewis) who are capable and have given consent to participate in a smartphone-based prehabilitation program.

Prehabilitation program

Intervention Type OTHER

Patient will be asked to follow to catalog of procedures till surgery. Procedures catalog contains behavioral changes, physical training, nutritional counseling, conditioning of pulmonary function and optimization of drug of underlying diseases.

Historical Cohort

Patients ≥ 65 years of age who have undergone tumor-related esophagectomy at the University Hospital of Cologne between 05/2016 and 04/2020, who have not participated in any form of prehabilitation procedures

No interventions assigned to this group

Interventions

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Prehabilitation program

Patient will be asked to follow to catalog of procedures till surgery. Procedures catalog contains behavioral changes, physical training, nutritional counseling, conditioning of pulmonary function and optimization of drug of underlying diseases.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients ,undergoing transthoracic esophagectomy (Ivor Lewis), in ≥ 4 weeks
* Age \>65 years
* American Society of Anaesthesiologists - Score: 2-3
* Ability to give informed consent
* Written informed consent

Exclusion Criteria

* Planned operation in less than 4 weeks after enrollment
* Urgent surgery indication
* Patients with good to excellent general and nutritional condition (0 points in the pre-screening of the modified NRS OR 1 point in the pre-screening and \<2 points in the main screening).
* Patients deemed by the PAPRIKA team to be physically or mentally incapable of completing the exercise program.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No