Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT04219956
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04219956
Study Brief:
Protocol Section:
NCT04219956