Condition category
Surgery
Date applied
04/05/2014
Date assigned
12/06/2014
Last edited
12/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.forskningsstod.sll.se

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

Publication citations

Additional files

Editorial Notes