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

NCT02328365 | Completed

• 1 other identifier: Comorbidity
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

Colorectal Cancer; Comorbidity; Perioperative Care; Surgery

Outcome Measures

Primary Outcomes (1)

• Postoperative mortality at one year

  One year

Secondary Outcomes (2)

• Short-term postoperative mortality

  30 days and 6 months

• Medical complications

  3 months

Other Outcomes (3)

• Hospitalization time

  30 days

• Readmissions

  3 months

• Findings and interventions at medical visits

  3 months

Study Arms (2)

Standard

NO INTERVENTION

Patients screened positive for cardiopulmonary disease and having a medical (pulmonary and/or cardiology) visit preoperatively, but randomized to standard follow-up

Intervention

EXPERIMENTAL

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

Interventions

Structured medical follow-up after operation OTHER

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients planned for elective surgical treatment of colorectal cancer at Vejle Hospital

You may not qualify if:

• Patients younger than 18 years, patients who are not legally competent, and patients with disseminated cancer and limited life expectancy

Sponsors & Collaborators

• Vejle Hospital: lead

Study Sites (1)

Vejle Hospital, Department of Surgery

Vejle, DK7100, Denmark

Location

Related Publications (1)

• 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.

  PMID: 31331339 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Hans B Rahr, MD DMSc

  Department of Surgery

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 31, 2014
• Study Start: March 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: March 27, 2018

Record last verified: 2018-03

Locations

DK (1)