Prevalence of Sleep Apnea in Patients Undergoing Surgery for Colorectal Cancer

Study Overview
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Brief Summary
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200 patients with colorectal cancer will be investigated before surgery and 100 of them after surgery. Investigations will include polysomonographic sleep apnea recordings during one night, lung function measurements, blood gas samples and questionnaires. Controls: Men and women from two population-based cohort studies

Detailed Description
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Inclusion: 200 patients with colorectal cancer will be investigated before surgery and 100 of them will also be investigated in the same manner after surgery. Due to drop-outs we calculate a need of inviting at least 250 patients. Exclusion: Dementia, CPAP treated sleep apnea investigations: Patients are investigated with lung function, blood-gas samples, questionnaires, overnight polysomnographic sleep apnea recordings including oro-nasal airflow, thoraco-abdominal respiration belts, chin-EMG, EOG, EEG, ECG (V5) and body position. Controls: Men and women from two population-based cohort studies the Sleep and health in women and the Men in Uppsala: A Study of Sleep, Apnea and Cardiometabolic Health and older men and women from a local senior organization. Outcomes: Prevalence of sleep apnea and hypoxia, sleep quality, and lung function, blood gas, STOP-BANG, Epworth sleepiness scale, Mallampati score, symptoms of sleep apnea, surgical complications, mortality, cancer severity.

Official Title
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Prevalence of Sleep Apnea in Patients Undergoing Surgery for Colorectal Cancer

Conditions
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Colorectal Cancer, Sleep Apnea Syndromes, Hypoxia

Intervention / Treatment
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* Procedure: Open surgery for colorectal cancer
* Procedure: Laparoscopic or robotic surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients scheduled for surgery of colorectal cancer Exclusion Criteria: Dementia, CPAP treatment for obstructive sleep apnea

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Before surgery<br>patients scheduled for surgery of colorectal cancer | |
| Open surgery for colorectal cancer<br>investigated after open surgery of colorectal cancer | Procedure: Open surgery for colorectal cancer<br> <br> |
| Laparoscopic or robotic surgery<br>investigated after laparoscopic or robot surgery of colorectal cancer | Procedure: Laparoscopic or robotic surgery<br> <br> |
| Control subjects<br>Controls from the population without colorectal cancer | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of sleep apnea | Apnea-hypopnea index | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality | total sleep time, sleep efficiency, time in different sleep stages | 1 week | 
| hypoxia, hypercapnia | blood-gas measurements | 1 week | 
| lung function | FVC, FEV1 | 1 week | 
| subjective sleepiness | Eworth sleepiness scale | 1 week | 
| Mortality | From the swedish death register | Until death | 
| Side effects of surgery | From local register | 30 days | 
| Severity of cancer | Morphologic analysis of cancer type | 30 days | 
| nocturnal hypoxia | Pulsoximetry during polysomnography | 1 week | 
| Mallampati score | Inspection of mouth | 1 day | 
| STOP-Bang | Risk factor stratification | 1 week | 
| Symptoms of sleep apnea | snoring, daytime sleepiness, witnessed sleep apneas | 1 month | 
| Sex differences | Effect of sex on outcome | 1 month |