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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 : Completed
First Posted : December 23, 2014
Last Update Posted : March 23, 2021
Sponsor:
Information provided by (Responsible Party):
Karl A Franklin, Umeå University

Tracking Information
First Submitted Date December 11, 2014
First Posted Date December 23, 2014
Last Update Posted Date March 23, 2021
Actual Study Start Date November 2014
Actual Primary Completion Date January 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 22, 2014)
  • 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 22, 2014)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prevalence of Sleep Apnea in Patients Undergoing Surgery for Colorectal Cancer
Official Title Prevalence of Sleep Apnea in Patients Undergoing Surgery for Colorectal Cancer
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.

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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients scheduled for surgery of colorectal cancer Healthy volunteers will be included as control subject
Condition
  • Colorectal Cancer
  • Sleep Apnea Syndromes
  • Hypoxemia
Intervention
  • Procedure: Open surgery for colorectal cancer
  • Procedure: Laparoscopic or robotic surgery
Study Groups/Cohorts
  • Before surgery
    patients scheduled for surgery of colorectal cancer
  • Open surgery for colorectal cancer
    investigated after open surgery of colorectal cancer
    Intervention: Procedure: Open surgery for colorectal cancer
  • Laparoscopic or robotic surgery
    investigated after laparoscopic or robot surgery of colorectal cancer
    Intervention: Procedure: Laparoscopic or robotic surgery
  • Control subjects
    Controls from the population without colorectal cancer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 22, 2021)
434
Original Estimated Enrollment
 (submitted: December 22, 2014)
300
Actual Study Completion Date January 31, 2018
Actual Primary Completion Date January 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients scheduled for surgery of colorectal cancer

Exclusion Criteria:

  • Dementia, CPAP treatment for obstructive sleep apnea
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT02323464
Other Study ID Numbers Dnr 2012-375-31M
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Karl A Franklin, Umeå University
Study Sponsor Karl A Franklin
Collaborators Not Provided
Investigators
Principal Investigator: Kar A Franklin, Ass prof Dept of Surgical and perioperative sciences, Umeå University
PRS Account Umeå University
Verification Date March 2021