Prevalence of Sleep Apnea in Patients Undergoing Surgery for Colorectal Cancer

Completed

• Conditions: Hypoxia; Colorectal Cancer; Sleep Apnea Syndromes
• Interventions: Procedure: Surgery for colorectal cancer; Other: No Interventions

• Registration Number: NCT02323464
• Lead Sponsor: Karl A Franklin

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-12-11
• Study First Submitted QC: 2014-12-22
• Study First Posted: 2014-12-23
• Study Start: 2015-01-07
• Primary Completion: 2021-04-28
• Study Completion: 2022-02-28
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-05
• Last Update Posted: 2023-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 434

Inclusion Criteria

• Patients scheduled for surgery of colorectal cancer

Exclusion Criteria

• Dementia, CPAP treatment for obstructive sleep apnea

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Before surgery	Surgery for colorectal cancer	patients scheduled for surgery of colorectal cancer
Control subjects	No Interventions	Controls from the population without colorectal cancer

Primary Outcome Measures

Name	Time	Method
Prevalence of sleep apnea	1 week	Apnea-hypopnea index

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dept of Surgery, Inst of Surgical and Perioperative sciences; 🇸🇪 Umeå, Umea, Sweden