Screening and Systematic Follow-up for Cardiopulmonary Comorbidity in Patients Having Surgery for Colorectal Cancer

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Structured medical follow-up after operation

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.

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Vejle, Denmark, DK7100
    • Vejle Hospital, Department of Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard; Patients screened positive for cardiopulmonary disease and having a medical (pulmonary and/or cardiology) visit preoperatively, but randomized to standard follow-up
Experimental: 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	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postoperative mortality at one year	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-term postoperative mortality		30 days and 6 months
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	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Readmissions		3 months
Hospitalization time		30 days
Findings and interventions at medical visits	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

Collaborators and Investigators

• Sponsor: Vejle Hospital
• Investigators: Study Chair: Hans B Rahr, MD DMSc, Department of Surgery

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: December 10, 2014
• First Submitted That Met QC Criteria: December 30, 2014
• First Posted (Estimate): December 31, 2014

Study Record Updates

• Last Update Posted (Actual): March 27, 2018
• Last Update Submitted That Met QC Criteria: March 26, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Perioperative Care; Surgery; Colorectal Cancer; Comorbidity
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: Comorbidity