Study to Evaluate the Efficacy of a Polyamine-deficient Diet for Treating Postoperative Pain After Abdominal Surgery
Recruiting now · Not applicable
Conditions studied: Digestive System Surgical Procedures
In brief
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.
Key facts
- Study ID
- NCT04219956
- Run by
- Nantes University Hospital
- People needed
- 278
- Starts
- 2020-02-03
- Expected to finish
- 2027-11-01
- Last updated by the study team
- 2025-11-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- CHRU Brest La Cavale Blanche — Brest, France (enrolling)
- Hôpital Louis Mourier from Ap-HP — Colombes, France (enrolling)
- CHD Vendée — La Roche-sur-Yon, France (enrolling)
- CHU Nantes Hôtel Dieu — Nantes, France (enrolling)
Full record on ClinicalTrials.gov
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