Prevalence of Sleep Apnea in Patients Undergoing Surgery for Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT02323464|
Recruitment Status : Recruiting
First Posted : December 23, 2014
Last Update Posted : November 10, 2020
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.
Investigations will include polysomonographic sleep apnea recordings during one night, lung function measurements, blood gas samples and a questionnaire, but only before surgery including questions on sleep, sleep apnea, lung disorders.
Outcome: side effects of surgery and mortality rate, association with cancer type.
Prevalence of sleep apnea, sleep quality, hypoxemia and lung function before and after surgery.
|Condition or disease||Intervention/treatment|
|Colorectal Cancer Sleep Apnea Syndromes Hypoxemia||Procedure: Open surgery for colorectal cancer Procedure: Laparoscopic or robotic surgery|
Group 1. Inclusion: 200 patients with colorectal cancer scheduled for surgery and 200 controls. Due to drop outs we calculate a need of inviting at least 250 patients with colorectal cancer. We will use controls from an ongoing epidemiological study of sleep apnea in the population.
Exclusion: Dementia, CPAP treated sleep apnea Methods: Patients are investigaged before surgery with Lung-function measurements, blood-gas sample, questionnaire, Overnight polysomnographic sleep apena recordings including oro-nasal airflow, thoraco-abdominal respiration belts, chin-EMG, EOG, EEG, ECG (V5) and body position.
Outcome variables: complications of surgery including anastomosis insuficiency and wound infections. Short and long term mortality, Sleep apnea, hypxoia, hyprecapnia and effect on lungfunction (VC, FEV1). Detailed morphologic analysis of cancer type.
Controls will be age and BMI matched from the population with exclusion of dementia and CPAP treated subjects
Investigations after surgery Inclusion: 100 patients with colorectal cancer scheduled for open or minimally invasive surgery surgery, Exclusion: Dementia, CPAP treated sleep apnea Methods: Patients are investigaged before and 2 days after surgery with Lung-function measurements, blood-gas sample, questionnaire (only before surgery), Overnight polysomnographic sleep apena recordings including oro-nasal airflow, thoraco-abdominal respiration belts, chin-EMG, EOG, EEG, ECG (V5) and body position.
Outcome variables: Effect on sleep apnea, sleep parameters, blood-gas and lungfunction before and after surgery. Complications of surgery including anastomosis insuficiency and wound infections. Short and long term mortality. Detailed morphologic analysis of cancer type.
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Prevalence of Sleep Apnea in Patients Undergoing Surgery for Colorectal Cancer|
|Actual Study Start Date :||November 2014|
|Actual Primary Completion Date :||August 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
patients scheduled for surgery of colorectal cancer
Open surgery for colorectal cancer
investigated after open surgery of colorectal cancer
Procedure: Open surgery for colorectal cancer
Laparoscopic or robotic surgery
investigated after laparoscopic or robot surgery of colorectal cancer
Procedure: Laparoscopic or robotic surgery
Controls from the population without colorectal cancer
- Side effects after surgery for colorectal cancer [ Time Frame: within 30 days ]From local cancer register
- Mortality [ Time Frame: Until death ]From the swedish death register
- Severity of cancer [ Time Frame: 30 days ]Morphologic analysis of cancer type
- Sleep apnea before and after surgery [ Time Frame: 1 week ]Apnea-hypopnea index
- Sleep quality [ Time Frame: 1 week ]total sleep time, sleep efficiency, time in different sleep stages
- hypoxemia, hypercapnia [ Time Frame: 1 week ]blood-gas measurements
- lung function [ Time Frame: 1 week ]FVC, FEV1
- subjective sleepiness [ Time Frame: 1 week ]From Eworth sleepiness scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02323464
|Contact: Karl A Franklin, Ass Prof||+46 email@example.com|
|Contact: Malin Sund, Prof||+46 firstname.lastname@example.org|
|Dept of Surgery, Inst of Surgical and Perioperative sciences||Recruiting|
|Umeå, Umea, Sweden, 901 85|
|Contact: Karl A Franklin, Ass prof +46 7850000 email@example.com|
|Principal Investigator:||Kar A Franklin, Ass prof||Dept of Surgical and perioperative sciences, Umeå University|