Screening and Systematic Follow-up for Cardiopulmonary Comorbidity in Patients Having Surgery for Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Structured medical follow-up after operation
Sponsored by

About this trial
This is an interventional prevention trial for Colorectal Cancer focused on measuring Colorectal Cancer, Comorbidity, Perioperative Care, Surgery
Eligibility Criteria
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
Sites / Locations
- Vejle Hospital, Department of Surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard
Intervention
Arm Description
Patients screened positive for cardiopulmonary disease and having a medical (pulmonary and/or cardiology) visit preoperatively, but randomized to standard follow-up
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
Outcomes
Primary Outcome Measures
Postoperative mortality at one year
Secondary Outcome Measures
Short-term postoperative mortality
Medical complications
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02328365
Brief Title
Screening and Systematic Follow-up for Cardiopulmonary Comorbidity in Patients Having Surgery for Colorectal Cancer
Official Title
Screening and Systematic Follow-up for Cardiopulmonary Comorbidity in Patients Having Surgery for Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
March 2014 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vejle Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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. 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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal Cancer, Comorbidity, Perioperative Care, Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
202 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard
Arm Type
No Intervention
Arm Description
Patients screened positive for cardiopulmonary disease and having a medical (pulmonary and/or cardiology) visit preoperatively, but randomized to standard follow-up
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Structured medical follow-up after operation
Intervention Description
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
Primary Outcome Measure Information:
Title
Postoperative mortality at one year
Time Frame
One year
Secondary Outcome Measure Information:
Title
Short-term postoperative mortality
Time Frame
30 days and 6 months
Title
Medical complications
Description
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
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
Hospitalization time
Time Frame
30 days
Title
Readmissions
Time Frame
3 months
Title
Findings and interventions at medical visits
Description
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)
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans B Rahr, MD DMSc
Organizational Affiliation
Department of Surgery
Official's Role
Study Chair
Facility Information:
Facility Name
Vejle Hospital, Department of Surgery
City
Vejle
ZIP/Postal Code
DK7100
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
31331339
Citation
Rahr HB, Streym S, Kryh-Jensen CG, Hougaard HT, Knudsen AS, Kristensen SH, Ejlersen E. Screening and systematic follow-up for cardiopulmonary comorbidity in elective surgery for colorectal cancer: a randomised feasibility study. World J Surg Oncol. 2019 Jul 22;17(1):127. doi: 10.1186/s12957-019-1668-7.
Results Reference
derived
Learn more about this trial
Screening and Systematic Follow-up for Cardiopulmonary Comorbidity in Patients Having Surgery for Colorectal Cancer
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