Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
459 participants
OBSERVATIONAL
2013-03-15
2017-10-01
Brief Summary
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Patients:All elective colorectal surgeries at the department of surgery, Umeå university Hospital, Umeå, Sweden from March 2013 to April 2017
Primary outcome:The primary outcome measurement is the numeric rating scale (NRS), graded from 0-10, on day of surgery, postoperative (POD) 1, 2, 3. The patients are questioned by nurses each morning on four postoperative days to score the maximum pain during the previous 24 hours using the NRS.
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Detailed Description
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Patients: This prospective cohort study includes all consecutive patients undergoing elective colorectal surgery at Umeå University Hospital in Sweden between March 2013 and April 2017.
Exclusion criteria: Patients who do not score pain at any of 4 postoperative days.
Primary outcome:The primary outcome measurement is the Numeric rating scale (NRS), graded from 0-10, where 0 = no pain and 10 = the worst imaginable pain \[18\]. Moderate pain is defined as NRS 4-6 and severe pain as NRS 7-10. The patients are questioned by nurses each morning after day of surgery, postoperative day. 1, postoperative day 2 and postoperative day 3 to score the maximum pain during the previous 24 hours using the NRS.
All data are registered in Enhanced recovery after surgery database (EISA)
Clinical variables: Baseline clinical variables are assessed preoperatively. They included age, gender, body mass index (BMI), smoking, a diabetes mellitus diagnosis and American Society of Anesthesia (ASA) class. The postoperative course is registered prospectively in Enhanced recovery after surgery register (EIAS) and include preoperative oncological treatment, a histopathologically verified cancer diagnosis, the length of hospital stay and complications, including any complication, Clavien-Dindo 3b or more and anastomotic leakage within 30 days after surgery High-sensitivity C-reactive protein (CRP) is measured every postoperative morning.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria: Patients not scoring pain at any of 4 postoperative days.
18 Years
ALL
No
Sponsors
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Umeå University
OTHER
Responsible Party
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Principal Investigators
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Karl A Franklin, prof
Role: PRINCIPAL_INVESTIGATOR
Dept Surgical and periopertive sciences, Umeå university, Sweden
Locations
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Dept of Surgery, Inst of Surgical and Perioperative sciences
Umeå, Umea, Sweden
Countries
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Other Identifiers
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2016/507-31
Identifier Type: -
Identifier Source: org_study_id
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