Prevalence of Sleep Apnea in Patients Undergoing Surgery for Colorectal Cancer

NCT02323464 | Completed DMC

• 1 other identifier: Dnr 2012-375-31M
• Study Type: observational
• Target: 212
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Colorectal Cancer; Sleep Apnea Syndromes; Hypoxia

Outcome Measures

Primary Outcomes (1)

• Prevalence of sleep apnea

  Apnea-hypopnea index

  1 week

Secondary Outcomes (12)

• Sleep quality

  1 week

• hypoxia, hypercapnia

  1 week

• lung function

  1 week

• subjective sleepiness

  1 week

• Mortality

  Until death

Study Arms (2)

Before surgery

patients scheduled for surgery of colorectal cancer

Procedure: Surgery for colorectal cancer

Control subjects

Controls from the population without colorectal cancer

Other: No Interventions

Interventions

Surgery for colorectal cancer PROCEDURE

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

Before surgery

No Interventions OTHER

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

Control subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients scheduled for surgery of colorectal cancer Healthy volunteers from population based studies will be included as controls

You may qualify if:

• Patients scheduled for surgery of colorectal cancer

You may not qualify if:

• Dementia, CPAP treatment for obstructive sleep apnea

Sponsors & Collaborators

• Karl A Franklin: lead

Study Sites (1)

Dept of Surgery, Inst of Surgical and Perioperative sciences

Umeå, Umea, 901 85, Sweden

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Sleep Apnea Syndromes; Hypoxia

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kar A Franklin, Ass prof

  Dept of Surgical and perioperative sciences, Umeå University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc prof

Study Record Dates

• First Submitted: December 11, 2014
• First Posted: December 23, 2014
• Study Start: January 7, 2015
• Primary Completion: April 28, 2021
• Study Completion: February 28, 2022
• Last Updated: September 27, 2024

Record last verified: 2024-09

Locations

SE (1)