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Completed

NCT Number: NCT02323464

Prevalence of Sleep Apnea in Patients Undergoing Surgery for Colorectal Cancer

212 patients with colorectal cancer will be investigated before surgery and 100 of them after surgery. 597 individuals from a previous population based study will serve as controls to the prevalence of sleep apnea in the general population.

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

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Key information

Conditions

Colorectal Cancer Apnea Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Dyssomnias Gastrointestinal Diseases Gastrointestinal Neoplasms Hypoxia Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Pathological Conditions, Signs and Symptoms Rectal Diseases Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept of Surgery, Inst of Surgical and Perioperative sciences

Umeå, Umea, 901 85, Sweden

About this study

Inclusion: 212 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.

Controls: 597 individuals from a previous population based study will serve as controls to the prevalence of sleep apnea in the general population.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients scheduled for surgery of colorectal cancer

Exclusion criteria

  • Dementia, CPAP treatment for obstructive sleep apnea

Treatment and study plan

Surgery for colorectal cancer

Procedure

Includes open and minimally invasive surgery for colon- and rectal cancer

No interventions

Other

This is a control group from the population. They are not scheduled for surgery

Primary outcomes

  1. Prevalence of sleep apnea

    Time frame: 1 week

    Apnea-hypopnea index

Secondary outcomes

  1. Sleep quality

    Time frame: 1 week

    total sleep time, sleep efficiency, time in different sleep stages

  2. hypoxia, hypercapnia

    Time frame: 1 week

    blood-gas measurements

  3. lung function

    Time frame: 1 week

    FVC, FEV1

  4. subjective sleepiness

    Time frame: 1 week

    Eworth sleepiness scale

  5. Mortality

    Time frame: Until death

    From the swedish death register

  6. Side effects of surgery

    Time frame: 30 days

    From local register

  7. Severity of cancer

    Time frame: 30 days

    Morphologic analysis of cancer type

  8. nocturnal hypoxia

    Time frame: 1 week

    Pulsoximetry during polysomnography

  9. Mallampati score

    Time frame: 1 day

    Inspection of mouth

  10. STOP-Bang

    Time frame: 1 week

    Risk factor stratification

  11. Symptoms of sleep apnea

    Time frame: 1 month

    snoring, daytime sleepiness, witnessed sleep apneas

  12. Sex differences

    Time frame: 1 month

    Effect of sex on outcome

Sponsors and collaborators

Lead sponsor

Karl A Franklin

Other

Registry information

Important dates

Study start
2015
Primary completion
2021
Study completion
2022
First posted
Dec 23, 2014
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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