NCT04219956 Study to Evaluate the Efficacy of a Polyamine-deficient Diet for Treating Postoperative Pain After Abdominal Surgery
| NCT ID | NCT04219956 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nantes University Hospital |
| Condition | Digestive System Surgical Procedures |
| Study Type | INTERVENTIONAL |
| Enrollment | 278 participants |
| Start Date | 2020-02-03 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 278 participants in total. It began in 2020-02-03 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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 Exclusion Criteria: * 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
Contact & Investigator
Claire Blanchard, MD-PhD
PRINCIPAL INVESTIGATOR
Nantes University Hospital
Frequently Asked Questions
Who can join the NCT04219956 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Digestive System Surgical Procedures. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04219956 currently recruiting?
Yes, NCT04219956 is actively recruiting participants. Contact the research team at claire.blanchard@chu-nantes.fr for enrollment information.
Where is the NCT04219956 trial being conducted?
This trial is being conducted at Brest, France, Colombes, France, La Roche-sur-Yon, France, Nantes, France.
Who is sponsoring the NCT04219956 clinical trial?
NCT04219956 is sponsored by Nantes University Hospital. The principal investigator is Claire Blanchard, MD-PhD at Nantes University Hospital. The trial plans to enroll 278 participants.