Patient Empowerment for Major Surgery Preparation @ Home (PAPRIKA)

University of Cologne

Status: Completed

Conditions: Transthoracic Esophagectomy

Treatments: Other: Prehabilitation program

Study type: Observational

Funder types: Other

Identifiers

NCT05167682

V02-20012021

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

26 participants in 2 patient groups

Prehabilitation

Description:

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

Treatment:

Other: Prehabilitation program

Historical Cohort

Description:

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