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

Study Overview

• Status: Completed
• Conditions: Sleep Apnea Syndromes; Hypoxia; Colorectal Cancer
• Intervention / Treatment: Procedure: Surgery for colorectal cancer; Other: No Interventions

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.

• Study Type: Observational
• Enrollment (Actual): 212

Contacts and Locations

Study Locations

• Sweden
  • Umea
    • Umeå, Umea, Sweden, 901 85
      • Dept of Surgery, Inst of Surgical and Perioperative sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients scheduled for surgery of colorectal cancer Healthy volunteers from population based studies will be included as controls

Description

Inclusion Criteria:

• Patients scheduled for surgery of colorectal cancer

Exclusion Criteria:

• Dementia, CPAP treatment for obstructive sleep apnea

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Before surgery; patients scheduled for surgery of colorectal cancer	Procedure: Surgery for colorectal cancer; Includes open and minimally invasive surgery for colon- and rectal cancer
Control subjects; Controls from the population without colorectal cancer	Other: No Interventions; This is a control group from the population. They are not scheduled for surgery

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Karl A Franklin
• Investigators: Principal Investigator: Kar A Franklin, Ass prof, Dept of Surgical and perioperative sciences, Umeå University

Study record dates

Study Major Dates

• Study Start (Actual): January 7, 2015
• Primary Completion (Actual): April 28, 2021
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: December 11, 2014
• First Submitted That Met QC Criteria: December 22, 2014
• First Posted (Estimated): December 23, 2014

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 25, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Neoplasms; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Colorectal Neoplasms; Apnea; Hypoxia
• Other Study ID Numbers: Dnr 2012-375-31M