Body swelling after surgery: the influence of poor fluid intake, inflammation and the choice of infusion fluid
| ISRCTN | ISRCTN72860921 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72860921 |
| Secondary identifying numbers | 2011/657-31/3 |
- Submission date
- 04/05/2014
- Registration date
- 12/06/2014
- Last edited
- 07/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
Research Unit, House 18
Södertälje Hospital
Södertälje
152 86
Sweden
| Phone | +46 (0) 855024670 |
|---|---|
| r.hahn@telia.com |
Study information
| Study design | Open randomized trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at: http://roberthahn.se/Oedema.pdf |
| 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 |
| Study acronym | MPO (Mechanisms of Postoperative Oedema) |
| Study objectives | That the increase in body weight after surgery can be related to certain preoperative factors. |
| Ethics approval(s) | Local Ethics Committee of Stockholm, 29/06/2011, ref. 2011/657-31/3 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/06/2012 |
| Completion date | 30/09/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | Adult patients (age >18 years) scheduled for surgery in general anaesthesia lasting for > 30 minutes |
| Key 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 |
| Date of first enrolment | 01/06/2012 |
| Date of final enrolment | 30/09/2015 |
Locations
Countries of recruitment
- Sweden
Study participating centre
152 86
Sweden
Sponsor information
Government
c/o Lena Olsén
Hantverkargatan 45
Box 22550
Stockholm
10422
Sweden
| Website | http://www.forskningsstod.sll.se |
|---|---|
"ROR" |
https://ror.org/02zrae794 |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2017 | Yes | No |
Editorial Notes
07/02/2018: Publication reference was added.
