Prevalence of Sleep Apnea in Patients Undergoing Surgery for Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title:

Prevalence of Sleep Apnea in Patients Undergoing Surgery for Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02323464
• Other study ID #: Dnr 2012-375-31M
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Apnea
• Colorectal Cancer
• Colorectal Neoplasms
• Hypoxia
• Sleep Apnea Syndromes

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