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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
Sponsor:
Information provided by (Responsible Party):
Karl A Franklin, Umeå University

Brief Summary:

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

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Before surgery
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
Control subjects
Controls from the population without colorectal cancer



Primary Outcome Measures :
  1. Side effects after surgery for colorectal cancer [ Time Frame: within 30 days ]
    From local cancer register

  2. Mortality [ Time Frame: Until death ]
    From the swedish death register

  3. Severity of cancer [ Time Frame: 30 days ]
    Morphologic analysis of cancer type

  4. Sleep apnea before and after surgery [ Time Frame: 1 week ]
    Apnea-hypopnea index


Secondary Outcome Measures :
  1. Sleep quality [ Time Frame: 1 week ]
    total sleep time, sleep efficiency, time in different sleep stages

  2. hypoxemia, hypercapnia [ Time Frame: 1 week ]
    blood-gas measurements

  3. lung function [ Time Frame: 1 week ]
    FVC, FEV1

  4. subjective sleepiness [ Time Frame: 1 week ]
    From Eworth sleepiness scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients scheduled for surgery of colorectal cancer Healthy volunteers will be included as control subject
Criteria

Inclusion Criteria:

  • Patients scheduled for surgery of colorectal cancer

Exclusion Criteria:

  • Dementia, CPAP treatment for obstructive sleep apnea

Information from the National Library of Medicine

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


Contacts
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Contact: Karl A Franklin, Ass Prof +46 706884745 karl.franklin@umu.se
Contact: Malin Sund, Prof +46 907850000 malin.sund@umu.se

Locations
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Sweden
Dept of Surgery, Inst of Surgical and Perioperative sciences Recruiting
Umeå, Umea, Sweden, 901 85
Contact: Karl A Franklin, Ass prof    +46 7850000    karl.franklin@surgery.umu.se   
Sponsors and Collaborators
Karl A Franklin
Investigators
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Principal Investigator: Kar A Franklin, Ass prof Dept of Surgical and perioperative sciences, Umeå University
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Responsible Party: Karl A Franklin, Assoc prof, Umeå University
ClinicalTrials.gov Identifier: NCT02323464    
Other Study ID Numbers: Dnr 2012-375-31M
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Additional relevant MeSH terms:
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Colorectal Neoplasms
Apnea
Sleep Apnea Syndromes
Hypoxia
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases