Prevalence of Sleep Apnea in Patients Undergoing Surgery for Colorectal Cancer

NCT ID: NCT02323464

Last Updated: 2024-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

212 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-07

Study Completion Date

2022-02-28

Brief Summary

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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

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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

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Colorectal Cancer Sleep Apnea Syndromes Hypoxia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Before surgery

patients scheduled for surgery of colorectal cancer

Surgery for colorectal cancer

Intervention Type PROCEDURE

Includes open and minimally invasive surgery for colon- and rectal cancer

Control subjects

Controls from the population without colorectal cancer

No Interventions

Intervention Type OTHER

This is a control group from the population. They are not scheduled for surgery

Interventions

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Surgery for colorectal cancer

Includes open and minimally invasive surgery for colon- and rectal cancer

Intervention Type PROCEDURE

No Interventions

This is a control group from the population. They are not scheduled for surgery

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled for surgery of colorectal cancer

Exclusion Criteria

* Dementia, CPAP treatment for obstructive sleep apnea
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Karl A Franklin

OTHER

Sponsor Role lead

Responsible Party

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Karl A Franklin

Assoc prof

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Kar A Franklin, Ass prof

Role: PRINCIPAL_INVESTIGATOR

Dept of Surgical and perioperative sciences, Umeå University

Locations

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Dept of Surgery, Inst of Surgical and Perioperative sciences

Umeå, Umea, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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Dnr 2012-375-31M

Identifier Type: -

Identifier Source: org_study_id

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