Patient Empowerment for Major Surgery Preparation @ Home

Transthoracic Esophagectomy Clinical Trial

— PAPRIKA  

Official title:

Patient Empowerment for Major Surgery Preparation @ Home

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05167682
• Other study ID #: V02-20012021
• Status: Completed
• Start date: July 1, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: June 2024
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: March 31, 2024
• Est. primary completion date: March 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Transthoracic Esophagectomy

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Germany	University Hospital of Cologne	Cologne

Sponsors (4)

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

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance of patients as feasibility of prehabilitation program	Percentage of patients will be assessed, who have successfully completed all study visits and have installed and used the smart phone app at least once	90 days after surgery
Secondary	Postoperative outcome	Postoperative outcome will be measured with occurrence of postoperative and patient-centric complications.	90 days after surgery