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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02323464
Other study ID # Dnr 2012-375-31M
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 7, 2015
Est. completion date February 28, 2022

Study information

Verified date December 2023
Source Umeå University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 434
Est. completion date February 28, 2022
Est. primary completion date April 28, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients scheduled for surgery of colorectal cancer Exclusion Criteria: - Dementia, CPAP treatment for obstructive sleep apnea

Study Design


Intervention

Procedure:
Open surgery for colorectal cancer

Laparoscopic or robotic surgery


Locations

Country Name City State
Sweden Dept of Surgery, Inst of Surgical and Perioperative sciences Umeå Umea

Sponsors (1)

Lead Sponsor Collaborator
Karl A Franklin

Country where clinical trial is conducted

Sweden, 

Outcome

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