Clinical trial NCT05167682: Patient Empowerment for Major Surgery Preparation @ Home
Official title: Patient Empowerment for Major Surgery Preparation @ Home
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transthoracic Esophagectomy
Keywords: Transthoracic esophagectomy
Prevention
Lead sponsor: University of Cologne
Sponsor class: OTHER
Collaborators: name: Department of General, Visceral, Tumor and Transplant Surgery, University Hospital Of Cologne
name: Centre for Prevention and Rehabilitation, University Hospital Cologne
name: Department of Endocrinology, Diabetology and Preventive Medicine
First posted: 2021-12-22
Enrollment: 26
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Male and female subjects with planned transthoracic esophagectomy in more than 4 weeks

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.


Eligibility 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.

Primary outcomes:
measure: Compliance of patients as feasibility of prehabilitation program
timeFrame: 90 days after surgery
Secondary outcomes:
measure: Postoperative outcome
timeFrame: 90 days after surgery
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne
Study officials:
affiliation: Department of General, Visceral and Transplantational Surgery, University Hospital of Cologne
name: Wolfgang Schröder, Prof.
role: STUDY_CHAIR
affiliation: Department of Internal Medicine II, University Hospital of Cologne
name: Paul Brinkkötter, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Internal Medicine II, University Hospital of Cologne
name: Linus Völker, MD
role: PRINCIPAL_INVESTIGATOR
References: