Colorectal CancerNCT02323464
Prevalence of Sleep Apnea in Patients Undergoing Surgery for Colorectal Cancer
An observational study of Colorectal Cancer and Sleep Apnea Syndromes, run by Karl A Franklin at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Sleep Apnea Syndromes, Hypoxia
- What is being tested?
- Surgery for colorectal cancer
- Type of treatment
- Surgery or procedure
- How many people
- 212 participants
- Where
- 1 siteSweden
- Study dates
- 7 Jan 2015to 28 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled for surgery of colorectal cancer Healthy volunteers from population based studies will be included as controls
Who may be able to join
- Patients scheduled for surgery of colorectal cancer
Who cannot join
- Dementia, CPAP treatment for obstructive sleep apnea
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept of Surgery, Inst of Surgical and Perioperative sciences
Umeå, Umea, 901 85
About this study
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
Read the 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
- Colorectal Cancer, Sleep Apnea Syndromes, Hypoxia
- Being tested
- Surgery for colorectal cancer, No Interventions
- Medical subject headings
- Colorectal Neoplasms, Sleep Apnea Syndromes, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery for colorectal cancerProcedure or surgery
Includes open and minimally invasive surgery for colon- and rectal cancer
No InterventionsOther
This is a control group from the population. They are not scheduled for surgery
| Study group | Role | What they receive |
|---|---|---|
| Before surgery | patients scheduled for surgery of colorectal cancer Receives: Procedure: Surgery for colorectal cancer | |
| Control subjects | Controls from the population without colorectal cancer Receives: Other: No Interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of sleep apnea
Apnea-hypopnea index
Measured: 1 week
Secondary outcomes (12)
Sleep quality
total sleep time, sleep efficiency, time in different sleep stages
Measured: 1 week
hypoxia, hypercapnia
blood-gas measurements
Measured: 1 week
lung function
FVC, FEV1
Measured: 1 week
subjective sleepiness
Eworth sleepiness scale
Measured: 1 week
Mortality
From the swedish death register
Measured: Until death
Side effects of surgery
From local register
Measured: 30 days
Severity of cancer
Morphologic analysis of cancer type
Measured: 30 days
nocturnal hypoxia
Pulsoximetry during polysomnography
Measured: 1 week
Mallampati score
Inspection of mouth
Measured: 1 day
STOP-Bang
Risk factor stratification
Measured: 1 week
Symptoms of sleep apnea
snoring, daytime sleepiness, witnessed sleep apneas
Measured: 1 month
Sex differences
Effect of sex on outcome
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study start7 Jan 2015
- Primary completion28 Apr 2021
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karl A Franklin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Karl A Franklin, Umeå University
- Investigators
- Kar A Franklin, Ass prof, Principal investigator, Dept of Surgical and perioperative sciences, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323464
- Sponsor's protocol ID
- Dnr 2012-375-31M
- Status last verified
- Sep 2024
- First submitted
- 11 Dec 2014
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Sleep Apnea in Patients Undergoing Surgery for Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02323464
- Acronym / sponsor ID
- Dnr 2012-375-31M
- Conditions
- Colorectal Cancer, Sleep Apnea Syndromes, Hypoxia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Karl A FranklinUniversity, hospital or other
- Study start
- 7 Jan 2015 (actual)
- Primary completion
- 28 Apr 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before surgery | – | Procedure: Surgery for colorectal cancerpatients scheduled for surgery of colorectal cancer |
| Control subjects | – | Other: No InterventionsControls from the population without colorectal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for surgery of colorectal cancer Healthy volunteers from population based studies will be included as controls
Key inclusion criteria (1 listed)
- Patients scheduled for surgery of colorectal cancer
Key exclusion criteria (1 listed)
- Dementia, CPAP treatment for obstructive sleep apnea
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery for colorectal cancerIncludes open and minimally invasive surgery for colon- and rectal cancer | Procedure or surgery | Before surgery |
| No InterventionsThis is a control group from the population. They are not scheduled for surgery | Other | Control subjects |
Primary outcome
Prevalence of sleep apnea
Time frame: 1 week
Apnea-hypopnea index
12 secondary outcomes
Sleep quality
Time frame: 1 week
hypoxia, hypercapnia
Time frame: 1 week
lung function
Time frame: 1 week
subjective sleepiness
Time frame: 1 week
Mortality
Time frame: Until death
Side effects of surgery
Time frame: 30 days
Severity of cancer
Time frame: 30 days
nocturnal hypoxia
Time frame: 1 week
Mallampati score
Time frame: 1 day
STOP-Bang
Time frame: 1 week
Symptoms of sleep apnea
Time frame: 1 month
Sex differences
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kar A Franklin, Ass prof principal investigator
Dept of Surgical and perioperative sciences, Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Sleep Apnea Syndromes, run by Karl A Franklin at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of sleep apnea (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.