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Prevalence of Sleep Apnea in Patients Undergoing Surgery for Colorectal Cancer

Prevalence of Sleep Apnea in Patients Undergoing Surgery for Colorectal Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02323464
Enrollment
212
Registered
2014-12-23
Start date
2015-01-07
Completion date
2022-02-28
Last updated
2024-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Hypoxia, Sleep Apnea Syndromes

Brief summary

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

Detailed description

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.

Interventions

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

OTHERNo Interventions

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

Sponsors

Karl A Franklin
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patients scheduled for surgery of colorectal cancer

Exclusion criteria

* Dementia, CPAP treatment for obstructive sleep apnea

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of sleep apnea1 weekApnea-hypopnea index

Secondary

MeasureTime frameDescription
hypoxia, hypercapnia1 weekblood-gas measurements
lung function1 weekFVC, FEV1
subjective sleepiness1 weekEworth sleepiness scale
MortalityUntil deathFrom the swedish death register
Side effects of surgery30 daysFrom local register
Sleep quality1 weektotal sleep time, sleep efficiency, time in different sleep stages
nocturnal hypoxia1 weekPulsoximetry during polysomnography
Mallampati score1 dayInspection of mouth
STOP-Bang1 weekRisk factor stratification
Symptoms of sleep apnea1 monthsnoring, daytime sleepiness, witnessed sleep apneas
Sex differences1 monthEffect of sex on outcome
Severity of cancer30 daysMorphologic analysis of cancer type

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026