Screening and Systematic Follow-up for Cardiopulmonary Comorbidity in Patients Having Surgery for Colorectal Cancer
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Background and overview
More than one third of patients with colorectal cancer (CRC) suffer from comorbidity such as heart and lung diseases. This comorbidity markedly impairs survival after surgical treatment owing to increased mortality within the first weeks to months after surgery, and this increased mortality is related to medical complications such as heart and lung complications. Since the operation itself constitutes a severe challenge to the patient's cardiopulmonary system, this study aims to elucidate whether a more systematic perioperative management and follow-up of colorectal cancer patients with cardiopulmonary comorbidity may improve their outcome as measured by complications, hospitalisation times, and survival within the first year.
All patients scheduled for elective surgical treatment of colorectal cancer at Vejle Hospital are screened by a study nurse for cardiopulmonary comorbidity to determine their eligibility for inclusion. If they fulfil inclusion criteria, they are seen preoperatively by a cardiologist and/or a pulmonary physician and undergo echocardiography and/or spirometry.
Included patients are randomized postoperatively to either standard follow-up alone ("standard" group) or standard follow-up supplemented with structured medical management and follow-up ("intervention" group). Patients in the intervention group are examined on the 4th or 5th postoperative day by an experienced physician from the Department of Internal Medicine. Furthermore, the intervention group is followed up at outpatient visits 1 and 3 months postoperatively. The 1-month visit includes a cardiology visit with echocardiography and ECG, and a pulmonary medicine visit with spirometry. The 3-month visit includes only a pulmonary medicine visit with spirometry.
Mortality, cardiopulmonary complications, hospitalisation time and treatment changes induced by the structured follow-up will be recorded as outcome measures for the intervention.
Hypothesis
Patients with cardiopulmonary comorbidity who have their standard follow-up extended to include a structured medical management and follow-up after surgery for colorectal cancer obtain a better outcome as measured by less cardiopulmonary morbidity and better survival within the first year.
Aim
To test a study design with systematic preoperative screening for cardiopulmonary comorbidity and postoperative randomization of eligible patients to either standard followup alone or standard follow-up supplemented with structured medical management and follow-up after operation for colorectal cancer.
Design
A randomized feasibility study. Based on older data, it will require approximately 400 patients in each arm to demonstrate a 10 % reduction in the expected mortality. This study aims to test the design and acquire more reliable mortality data in each arm in order to establish the basis for a larger multicentre study.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Vejle, Danimarca, DK7100
- Vejle Hospital, Department of Surgery
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- All patients planned for elective surgical treatment of colorectal cancer at Vejle Hospital
Exclusion Criteria:
- Patients younger than 18 years, patients who are not legally competent, and patients with disseminated cancer and limited life expectancy
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Nessun intervento: Standard
Patients screened positive for cardiopulmonary disease and having a medical (pulmonary and/or cardiology) visit preoperatively, but randomized to standard follow-up
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|
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Sperimentale: Intervention
Patients screened positive for cardiopulmonary disease and having a medical (pulmonary and/or cardiology) visit preoperatively, but randomized to structured medical follow-up after operation
|
Patients in the intervention arm are seen by a physician on the 4th or 5th postoperative day before discharge to pick up and manage any medical problems, and are furthermore seen in the cardiology clinic 1 month after operation, and in the pulmonary medicine clinic 1 and 3 months after operation
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Postoperative mortality at one year
Lasso di tempo: One year
|
One year
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Short-term postoperative mortality
Lasso di tempo: 30 days and 6 months
|
30 days and 6 months
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|
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Medical complications
Lasso di tempo: 3 months
|
Incidence of postoperative medical complications as classified in the Danish national bowel cancer database (stroke, ACS, aspiration, pneumonia, heart failure, arrhythmia, pulmonary embolism, lung failure, renal failure, sepsis, deep vein thrombosis, arterial embolism, other) and graded according to Clavien.
Particular focus on cardiopulmonary complications
|
3 months
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Riammissioni
Lasso di tempo: 3 mesi
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3 mesi
|
|
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Tempo di ricovero
Lasso di tempo: 30 giorni
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30 giorni
|
|
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Findings and interventions at medical visits
Lasso di tempo: 3 months
|
Incidence of intercurrent or present medical complications as described in Outcome 3. Judgement whether the complication was 1. already identified and optimally managed by others, 2. identified but not optimally managed, or 3. was undisclosed until the medical visit.
Any interventions by the visiting physician graded (no intervention, change in medication, unplanned outpatient visit, admission to hospital as inpatient)
|
3 months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Hans B Rahr, MD DMSc, Department of Surgery
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- Comorbidity
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