Major Abdominal Surgery
Conditions
Brief summary
The main objective of this study was to evaluate the effect of intermittent pneumatic venous compression on intra-operative fluid intake by comparing two groups of patients with or without intermittent pneumatic compression of the lower limbs.
Interventions
Intermittent pneumatic venous compression is applied to the lower limbs of patients during surgery.
PROCEDUREStandard care
Intermittent pneumatic venous compression is not applied to the lower limbs of patients during surgery.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient must have given his/her informed and signed consent * The patient must be insured or beneficiary of a health insurance plan * Patient with ASA score 1-3 * Body mass index \< 30 kg/m\^2 * Patient is schelduled for major abdominal surgery (laparotomy without risk of haemorrhage whose duration is assumed to be greater than 120 min) * The patient passes from home, directly to the hospital, without schelduled hospitalization in another department
Exclusion criteria
* The patient is participating in another study * The patient is in an exclusion period determined by a previous study * The patient is under judicial protection, under tutorship or curatorship * The patient refuses to sign the consent * It is impossible to correctly inform the patient * The patient is pregnant * The patient is breastfeeding * The patient has a contra-indication for treatment necessary for the study * ASA score \> 3 * body mass index \> 30 kg/m\^2 * Expected surgical time of \< 120 minutes * Surgery with risk of hemorrhage * Surgery via celioscopy * The surgery require perineal access, thus rendering any blinding impossible * Hepatic surgery * Contra indication for intermittent venous compression
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume fluids (ml) | End of surgery (expected mean of 2 hours) | The total volume of infused fluids (Ringer's Lactate and HES) delivered to the patient during surgery (ml) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VEGF | end of surgery (expected mean of 2 hours) | Concentration (pg/ml) of Vascular Endothelial Growth Factor (VEGF) in blood |
| sFlt1 | end of surgery (expected mean of 2 hours) | Concentration (pg/ml) of soluble vascular endothelial growth factor receptor-1 (sFlt1) in blood |
| Hematocrit % | end of surgery (expected mean of 2 hours) | — |
| Albumin | end of surgery (expected mean of 2 hours) | Albuminemia (g/l) |
| Hypotensive episodes | end of surgery (expected mean of 2 hours) | The number of arterial hypotension episodes (systolic pressure \< 90 mmHg) |
| Activated partial thromboplastin time | end of surgery (expected mean of 2 hours) | Activated partial thromboplastin time (seconds) |
| Presence/absence of POSSUM complications | 28 days | Presence/absence of complications as defined by the Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity (POSSUM) criteria |
| Days of hospitalization | 28 days | Length of hospitalization (days) |
| Number of days not in hospital | 28 days | Number of days not in hospital |
| Prothrombin (%) | end of surgery (expected mean of 2 hours) | Prothrombin rate in blood |
Countries
France
Outcome results
None listed