About this trial
The aim of this study is to evaluate if a polyamine deficient diet started 7 days prior to a major abdominal surgery (eventration cure and digestive continuity) and followed 7 days post-surgery reduces the area under the curve of the numerical pain rating scale in the 72 hours post-surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult (>18 years)
Indication for a " major " abdominal surgery as second surgical procedure : cure of eventration and restoration of digestive continuity
Intended Use of a Patient Controlled Morphine Pump (PCA) postoperatively or taking oral opioids
Possible follow-up during 7 months (post-operative consultation at 1 month and 6 months only if postoperative pain or complications)
Disqualifiers
Pregnant women
Minor, adult under guardianship or benefiting from a legal protection
Oncological surgery
Surgery not painful (cholecystectomy, hernia, thyroidectomy, bariatric surgery)
Trial design
Parallel
Treatments tested in this trial
Polyamine Deficient Diet
Other interventionDiet low in polyamines: the estimated calculated dose is 20 times lower that in an usual diet
Treatment groups
Trial outcomes
Primary outcomes
To show a 20% decrease of the area under the curve for the numerical pain rating scale in the 72 hours post-operative in the polyamine deficient diet group
To show a 20% decrease of the area under the curve for the numerical pain rating scale in the 72 hours post-operative in the polyamine deficient diet group measured every 6 hours in resting position, upon return from the operative room
Secondary outcomes
Change in the analgesics consumption post-operatively
Measure of the analgesics consumption by the nurse during hospitalisation and by the patient with the patient book up to 15 days postsurgery
Change in the main dimension of pain
Evaluation of the main dimension of pain using the Brief Pain Inventory (BPI)
Change of the recovery time of the gas transit
Evaluation of the time to recover the gas transit post-surgery (in days)
Change of duration of urinary catheterization
Recovery of spontaneous urination post-surgery (in days)
Sponsors and contacts
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Nantes University Hospital
Lead sponsor
Centre de Recherche en Nutrition Humaine Ouest (CRNH)
Collaborator