Plain English Summary
Background and study aims
Body swelling (a buildup of fluid under the skin) often happens after surgery. The aim of this trial is to investigate the reasons to why it happens. The infusion fluids used in the surgery (e.g. resuscitating fluids), the amount of fluid taken by the patient before the surgery, whether the patient suffers from an inflammatory disease and surgical stress (how the body responds to the surgery) are all possible factors that may influence the amount of swelling that occurs after an operation.
Who can participate?
Adult patients (aged at least 18 years), scheduled for surgery that will last for longer than 30 minutes.
What does the study involve?
Urine samples are taken from the patients before, during and after surgery. A blood sample will also be taken the morning after the operation. Patients will be receive either a crystalloid or a colloid infusion fluid during the surgery and be weighted daily until they leave the hospital. Any complications will be recorded.
What are the possible benefits and risks of participating?
The researchers do not believe that there are any benefits or medical risk involved. There may be pain involved when the blood sample is taken.
Where is the study run from?
Södertälje Hospital, Sweden
When is the study starting and how long is it expected to run for?
June 2012 to September 2015
Who is funding the study?
Stockholm County Council (Sweden)
Who is the main contact?
Professor Robert Hahn
r.hahn@telia.com
Trial website
Contact information
Type
Scientific
Primary contact
Prof Robert Hahn
ORCID ID
Contact details
Research Unit
House 18
Södertälje Hospital
Södertälje
152 86
Sweden
+46 (0) 855024670
r.hahn@telia.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2011/657-31/3
Study information
Scientific title
Mechanisms of oedema after general surgery; a randomized clinical trial of the choice of fluid and the influences of preoperative dehydration, inflammation and surgical stress
Acronym
MPO (Mechanisms of Postoperative Oedema)
Study hypothesis
That the increase in body weight after surgery can be related to certain preoperative factors.
Ethics approval
Local Ethics Committee of Stockholm, 29/06/2011, ref. 2011/657-31/3
Study design
Open randomized trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Patient information can be found at: http://roberthahn.se/Oedema.pdf
Condition
General surgery
Intervention
Randomization between using a colloid or a crystalloid fluid for plasma volume support during the surgery. Blood and urine sampling. Recording of postoperative complications according to a prospective survey.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measures
Increase in body weight from before up to the morning after surgery
Secondary outcome measures
1. Dehydration as evaluated by urine samples before surgery
2. Stress and inflammation as detected by serum cortisol and CRP in the morning after the surgery was performed
Overall trial start date
01/06/2012
Overall trial end date
30/09/2015
Reason abandoned
Eligibility
Participant inclusion criteria
Adult patients (age >18 years) scheduled for surgery in general anaesthesia lasting for > 30 minutes
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Endocrinological disease (such as diabetes)
2. Kidney disease
3. Dementia
4. Heart disease that affects physical performance
5. Difficulty understanding the Swedish language
Recruitment start date
01/06/2012
Recruitment end date
30/09/2015
Locations
Countries of recruitment
Sweden
Trial participating centre
Research Unit, House 18
Södertälje
152 86
Sweden
Sponsor information
Organisation
Stockholm County Council (Sweden)
Sponsor details
c/o Lena Olsén
Hantverkargatan 45
Box 22550
Stockholm
10422
Sweden
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Stockholm County Council (Sweden), grant 20100211
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary