Clinical Trials Directory

Trials / Completed

CompletedNCT02323464

Prevalence of Sleep Apnea in Patients Undergoing Surgery for Colorectal Cancer

Status
Completed
Phase
Study type
Observational
Enrollment
212 (actual)
Sponsor
Karl A Franklin · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDURESurgery for colorectal cancerIncludes open and minimally invasive surgery for colon- and rectal cancer
OTHERNo InterventionsThis is a control group from the population. They are not scheduled for surgery

Timeline

Start date
2015-01-07
Primary completion
2021-04-28
Completion
2022-02-28
First posted
2014-12-23
Last updated
2024-09-27

Locations

1 site across 1 country: Sweden

Source: ClinicalTrials.gov record NCT02323464. Inclusion in this directory is not an endorsement.