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Patient Empowerment for Major Surgery Preparation @ Home

Patient Empowerment for Major Surgery Preparation @ Home

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05167682
Acronym
PAPRIKA
Enrollment
26
Registered
2021-12-22
Start date
2021-07-01
Completion date
2024-03-31
Last updated
2024-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transthoracic Esophagectomy

Keywords

Transthoracic esophagectomy, Prevention

Brief summary

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.

Interventions

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.

Sponsors

Department of General, Visceral, Tumor and Transplant Surgery, University Hospital Of Cologne
CollaboratorUNKNOWN
Centre for Prevention and Rehabilitation, University Hospital Cologne
CollaboratorUNKNOWN
Department of Endocrinology, Diabetology and Preventive Medicine
CollaboratorUNKNOWN
University of Cologne
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Compliance of patients as feasibility of prehabilitation program90 days after surgeryPercentage of patients will be assessed, who have successfully completed all study visits and have installed and used the smart phone app at least once

Secondary

MeasureTime frameDescription
Postoperative outcome90 days after surgeryPostoperative outcome will be measured with occurrence of postoperative and patient-centric complications.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026