Informations générales (source: ClinicalTrials.gov)
A Prospective Randomized Multicenter Study to Evaluate the Efficacy of a Polyamine-deficient Diet for the Treatment of Postoperative Pain After Abdominal Surgery. (POLYAMAL)
Interventional
N/A
Nantes University Hospital (Voir sur ClinicalTrials)
février 2020
novembre 2027
24 août 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Louis Mourier | David MOSZKOWICZ, Pr | Contact (sur clinicalTrials) | |||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHD Vendée - La Roche-sur-Yon - France | Emeric Abet | Contact (sur clinicalTrials) | |||
| CHRU Brest La Cavale Blanche - Brest - France | Jérémie Thereaux, MD PhD | Contact (sur clinicalTrials) | |||
| CHU Nantes Hôtel Dieu - Nantes - France | Blanchard Claire, MD PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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)
- Written informed consent form obtained from the patient
- Affiliated to the social security
- 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)
- Written informed consent form obtained from the patient
- Affiliated to the social security
- Pregnant women
- Minor, adult under guardianship or benefiting from a legal protection
- Oncological surgery
- Surgery not painful (cholecystectomy, hernia, thyroidectomy, bariatric surgery)
- Drug addicts patients, or under opiate dependency
- Chronic pain patients (pain over 3 months)
- Patients in nursing home or convalescence home (diet non possible in institution)
- Planned hospitalisation before the intervention (during the 7 days before the
surgery)
- Severe undernutrition defined by the HAS criteria (weight loss > 10% in 1 month
and/or > 15% in 6 months, albumin at inclusion <15g/l)
- Patient refusing the possibility to change his eating habits
- Oral feeding impossible preoperatively
- Patient not able to express himself on their pain (silent, ...)
- Decompensated psychiatric pathologies (severe depression syndrome,...)
- Patient unable to understand the protocol and/or to give his informed consent