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Screening and systematic follow-up for cardiopulmonary comorbidity in elective surgery for colorectal cancer: a randomised feasibility study.

ABSTRACT: BACKGROUND:One third of patients with colorectal cancer (CRC) have comorbidity, which impairs their postoperative outcomes. Scoring systems may predict mortality, but there is limited evidence of effective interventions in high-risk patients. Our aim was to test a trial setup to assess the effect of extra postoperative medical visits and follow-up on 1-year mortality and other outcomes in patients with cardiopulmonary risk factors undergoing elective surgery for colorectal tumours. METHODS:Patients preoperatively screened positive for cardiopulmonary comorbidity were eligible. On postoperative day 4, they were randomised to either routine follow-up (RFU) or RFU with one extra medical visit and additional visits to the Cardiology and Respiratory Medicine Clinics 1 and 3 months postoperatively. The primary outcome measure was 1-year mortality; secondary outcome measures were length of stay (LOS), complications, and readmissions. RESULTS:Of 673 screened patients 326 (48%) were found eligible, 108 declined participation, and 198 were randomised. Postoperative medical problems and/or need for intervention were found in 15-23% of the patients at the extra medical visits. The 90-day mortality was 0 and the 1-year mortality only 2.6% with no differences between the two groups. LOS and complication rates did not differ, but there were significantly fewer readmissions in the intervention group. CONCLUSIONS:The 1-year mortality after elective CRC surgery was low, even in the presence of cardiopulmonary risk factors. There was no evidence of reduced mortality with additional medical follow-up in these patients. TRIAL REGISTRATION:ClinicalTrials.gov NCT02328365 registered 31 December 2014 (retrospectively registered).

SUBMITTER: Rahr HB

PROVIDER: S-EPMC6647202 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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Screening and systematic follow-up for cardiopulmonary comorbidity in elective surgery for colorectal cancer: a randomised feasibility study.

Rahr Hans B HB Streym Susanna S Kryh-Jensen Charlotte G CG Hougaard Helene T HT Knudsen Anne S AS Kristensen Steffen H SH Ejlersen Ejler E

World journal of surgical oncology 20190722 1

<h4>Background</h4>One third of patients with colorectal cancer (CRC) have comorbidity, which impairs their postoperative outcomes. Scoring systems may predict mortality, but there is limited evidence of effective interventions in high-risk patients. Our aim was to test a trial setup to assess the effect of extra postoperative medical visits and follow-up on 1-year mortality and other outcomes in patients with cardiopulmonary risk factors undergoing elective surgery for colorectal tumours.<h4>Me ...[more]

PMID: 31331339

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Project description:BACKGROUND:Screening flexible sigmoidoscopy reduces incidence and mortality of colorectal cancer. Previously reported results from the Prostate, Lung, Colorectal, and Ovarian Cancer (PLCO) screening trial had a median follow-up of 12 years. Whether the benefit is sustained over the long term and remains so in both sexes and all age groups is uncertain. We report long-term results after an additional 5 years of follow-up. METHODS:Participants in the PLCO trial were recruited from the general population in the catchment areas of ten screening centres across the USA, without previous diagnosis of a prostate, lung, colorectal, or ovarian cancer or current cancer treatment. From 1993 to 2001, participants aged 55-74 years were randomly assigned to usual care or flexible sigmoidoscopy at baseline and again at 3 years or 5 years. Randomisation was done within blocks and stratified by centre, age, and sex. The primary endpoint was cause-specific mortality and secondary endpoints included incidence and tumour staging; cause of death was determined without knowledge of study arm. In this analysis, we assessed incidence and mortality rates overall, by time-period, and by combinations of sex, age at baseline (55-64 years/65-74 years), location (distal/proximal), and stage, on an intent-to-treat basis. This trial is registered with ClinicalTrials.gov, number NCT00002540. FINDINGS:After a median follow-up of 15·8 years (IQR 13·2-18·0) for incidence and 16·8 years (14·4-18·9) for mortality, the incidence of colorectal cancer was significantly lower in the intervention arm (1461 cases; 12·55 per 10?000 person-years) than with usual care (1761 cases; 15·33 per 10?000 person-years; relative risk [RR] 0·82, 95% CI 0·76-0·88). Similarly, mortality was lower in the intervention arm (417 deaths; 3·37 per 10?000 person-years) than the usual care arm (549; 4·48 per 10?000 person-years; RR 0·75, 95% CI 0·66-0·85). The reduction in mortality was limited to the distal colon, with no significant effect in the proximal colon. Reductions in incidence were significantly larger in men than women (pinteraction=0·04) and reductions in mortality were significantly larger in the older age group (65-74 years vs 55-64 years at baseline; pinteraction=0·01). INTERPRETATION:Reductions in colorectal cancer incidence and mortality from flexible sigmoidoscopy screening are sustained over the long term. Differences by sex and age should be examined in other ongoing trials of colorectal cancer screening to help clarify if different screening strategies would achieve greater risk reduction. FUNDING:Extended follow-up was funded under NIH contract HHSN261201600007I.

Dataset Information

Screening and systematic follow-up for cardiopulmonary comorbidity in elective surgery for colorectal cancer: a randomised feasibility study.

Publications

Screening and systematic follow-up for cardiopulmonary comorbidity in elective surgery for colorectal cancer: a randomised feasibility study.

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