In this study, we investigate the possibility of preoperatively estimating the risk of complications in patients using the FitMáx, VSAQ, and PREOP checklist. These questionnaires are automatically administered via the Mijn MMC patient portal two…
ID
Source
Brief title
Condition
- Renal and urinary tract therapeutic procedures
- Endocrine gland therapeutic procedures
- Vascular therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
- Other intervention
N.a.
Outcome measures
Primary outcome
<p><strong>Primary Outcome Measures</strong></p><ol><li><strong>Complications:</strong> Occurrence of postoperative complications within <strong>30 days after surgery</strong>.</li><li><strong>Mortality:</strong> Postoperative death within <strong>30 days after surgery</strong>.</li><li><strong>Survival:</strong> Death within <strong>1 year after surgery</strong>.</li></ol>
Secondary outcome
<p><strong>Secondary Outcome Measures</strong></p><ol><li><strong>Length of hospital stay:</strong> Total duration of hospitalization, measured in days.</li><li><strong>Readmissions:</strong> Number of hospital readmissions within <strong>30 days after discharge</strong>.</li><li><strong>Morbidity:</strong> Assessment of health status after surgery <strong>up to one year post-procedure</strong>.</li></ol>
Background summary
Cardiorespiratory fitness (CRF) is defined as the capacity to absorb, transport, and utilize oxygen for cellular respiration, reflecting an individual's functional capability. Surgical procedures requiring anesthetic support impose increased metabolic demands on the body's cardiorespiratory system. Patients with low CRF have a higher risk of postoperative complications, including mortality and prolonged hospital stays. Particularly in patients with low CRF, promising effects have been observed from prehabilitation programs aimed at improving CRF before surgery. This underscores the importance of timely identification of patients with low CRF to advise, support, and consider prehabilitation.
In the current clinical preoperative setting, CRF is subjectively estimated by anesthesiologists using the PREOP checklist. If low CRF is suspected with an associated increased risk of complications, further assessment is conducted before surgery. Evaluating CRF through an objective measurement of oxygen uptake (VO2 peak) during a maximal cardiopulmonary exercise test (CPET) is considered the gold standard, leading to a more accurate risk assessment. Additionally, CPET provides valuable insights into the causes of exercise limitations. Various risk thresholds for objectively measured preoperative VO2 peak have been described to predict postoperative complications. However, CPET is expensive, labor-intensive, and requires extensive (patho-)physiological knowledge for interpretation, especially in patients with multiple comorbidities, making it less broadly applicable for preoperative risk assessment.
Patient-reported questionnaires are often used as an alternative for estimating VO2 peak. The FitMáx questionnaire, developed and validated by the Sports Medicine Department of Máxima MC, is designed to accurately assess CRF. The correlation between VO2 peak estimated with FitMáx and objectively measured VO2 peak during CPET is r=0.94 (0.92-0.95) in both patients and healthy individuals [1].
In a recent publication [2], we compared different patient-reported questionnaires (FitMáx, Veterans-Specific Activity Questionnaire (VSAQ), Duke Activity Status Index (DASI), and the PREOP checklist) for estimating preoperative CRF in non-surgical patients. We applied literature-based, population-dependent cutoff values for peak oxygen uptake and demonstrated that FitMáx performed better in identifying high-risk patients scoring below the defined cutoff values compared to DASI and PREOP, and at least as well as VSAQ. A key critique from reviewers of this study was that it involved non-surgical patients who underwent CPET for other reasons and completed the questionnaires. Additionally, they raised the question of whether the questionnaire results, beyond VO2 peak threshold values, could also be used to assess the risk of complications.
Now, we aim to evaluate the accuracy of preoperative CRF assessment in relation to surgical outcomes (e.g., complications, hospital stay duration, and mortality). We will administer the FitMáx (alongside VSAQ, DASI, and PREOP) to patients undergoing surgical procedures requiring anesthetic support at Máxima MC. We will use a modified FitMáx, which, in addition to assessing walking, stair climbing, and cycling, includes daily activities. This modification was necessitated by the increasing use of electric bicycles, prompting an essential update in our ongoing validation study at the hospital.
Study objective
In this study, we investigate the possibility of preoperatively estimating the risk of complications in patients using the FitMáx, VSAQ, and PREOP checklist. These questionnaires are automatically administered via the Mijn MMC patient portal two weeks before the scheduled surgery date. Relevant data regarding the surgery, postoperative outcomes, and survival are tracked for up to one year after the procedure.
After data collection, we evaluate the association between patient-reported VO2 peak through the questionnaires and postoperative outcomes (e.g., complications, morbidity, mortality, length of hospital stay). Additionally, we compare the associations and practical usability of the FitMáx with those of the VSAQ, DASI, and PREOP checklist.
Study design
This study consists of two phases.
In the first phase, the FitMáx, VSAQ, and DASI will be combined into a single questionnaire for patients undergoing surgical treatment at Máxima MC. This questionnaire will be provided two weeks before the planned surgery via Mijn MMC, along with the standard PREOP checklist. Through Mijn MMC, we will request consent to access surgical reports, associated postoperative follow-up correspondence, relevant patient characteristics, length of hospital stay, and documented complications. Completing the questionnaire will take approximately five minutes.
In the second phase, we will collect data on complications and mortality from the electronic patient record (EPR) for up to one year after surgery. We will assess the accuracy of these questionnaires in preoperatively estimating the risk of postoperative complications and overall surgical outcomes in patients.
Study Participants
Inclusion will be automatically facilitated via Mijn MMC, where patients, after providing consent, will receive access to the questionnaires.
Inclusion Criteria
- Patients scheduled for surgical treatment at Máxima MC
- ≥18 years old
Patients will be asked via Mijn MMC whether they are willing to participate in the questionnaire study. Once they agree, the questionnaires will become visible.
Intervention
FitMáx©
DASI
VSAQ
PREOP
Study burden and risks
Neglectible
Listed location countries
Age
Inclusion criteria
Inclusion
- Patients scheduled for a surgical procedure at Máxima MC;
- ≥18 years old.
Exclusion criteria
Acute surgical intervention (<7 days) and outpatient surgical interventions
Design
Recruitment
Medical products/devices used
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
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Research portal | NL-010038 |