Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-29 @ 7:07 PM
Study NCT ID:
NCT04219956
Status:
RECRUITING
Last Update Posted:
2025-11-14
First Post:
2020-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Efficacy of a Polyamine-deficient Diet for Treating Postoperative Pain After Abdominal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'The anesthetist is blinded to the arm of attribution'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 278}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-13', 'studyFirstSubmitDate': '2020-01-03', 'studyFirstSubmitQcDate': '2020-01-06', 'lastUpdatePostDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-01-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'timeFrame': '72 hours post-surgery', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Change in the analgesics consumption post-operatively', 'timeFrame': '15 days post-surgery', 'description': 'Measure of the analgesics consumption by the nurse during hospitalisation and by the patient with the patient book up to 15 days postsurgery'}, {'measure': 'Change in the main dimension of pain', 'timeFrame': '6 months post-surgery', 'description': 'Evaluation of the main dimension of pain using the Brief Pain Inventory (BPI)'}, {'measure': 'Change of the recovery time of the gas transit', 'timeFrame': '6 months post-surgery', 'description': 'Evaluation of the time to recover the gas transit post-surgery (in days)'}, {'measure': 'Change of duration of urinary catheterization', 'timeFrame': '6 months post-surgery', 'description': 'Recovery of spontaneous urination post-surgery (in days)'}, {'measure': 'Change in the delay before the first postoperative lift', 'timeFrame': '6 months post-surgery', 'description': 'Time before walking post-surgery (in days)'}, {'measure': 'Change in length of hospitalisation stay and sick leave', 'timeFrame': '6 months post-surgery', 'description': 'Hospitalisation time and sick leave (in days)'}, {'measure': 'Change in neuropathic pain: Neuropathic pain scale (DN4)', 'timeFrame': '6 months post-surgery', 'description': 'Use of the Neuropathic pain scale for patients seen for their postsurgery pain or complications. The scale contains 10 questions, the range is between 0-10, 10 being the worst score.'}, {'measure': 'Change in global health status', 'timeFrame': '1 month before surgery, 1 month and 6 months post-surgery', 'description': 'Use of autoquestionnaire EuroQol-5 Dimension (EQ-5D) to evaluate the global health status of the patients. The scale contains two parts, the first one contains 5 items to be completed by the patients with 5 levels for each item, the worst score being 55555. The second part is an analog visual scale with a range between 0-100, 0 being the worst score.'}, {'measure': 'Change of the recovery ability', 'timeFrame': '1 month before surgery, 1 month and 6 months post-surgery', 'description': 'Evaluation of the recovery ability using the Quality of Recovery-15 Questionnaire (QoR-15)'}, {'measure': 'Change in the quality of life', 'timeFrame': '1 month before surgery, 1 month and 6 months post-surgery', 'description': "Assessment of the patient's quality of life by using the Short-Form Health Survey 36 questionnaire (SF-36)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Abdominal surgery', 'Polyamine', 'Postoperative pain', 'Morphine', 'Hypersensitivity'], 'conditions': ['Digestive System Surgical Procedures']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Morphine derivatives are known to be a major cause of postoperative ileus and also operative hyperalgesia. Operative hyperalgesia corresponds to an increase in morphine needs postoperatively which is proportional to the morphine dose necessary during the surgery. This effect is due to two mechanisms: opioids tolerance and induced hypersensitivity.\n\nN-methyl-D-aspartate receptors (R-NMDA) play a key role in this induced hypersensitivity. Polyamines, organic compounds with several amines functions, are known R-NMDA agonists. They increase the phosphorylation of the tyrosine group within the NR2B subunit responsible for the inflammatory hyperalgesia.\n\nLimiting the binding of polyamines to the R-NMDA seems an easy, safe and efficient way to limit the hypersensitivity induced post-operatively.\n\nMost of the polyamines in the human body come from food. One study listed food regarding their polyamines content and allowed to check the safety of a polyamine deficient diet. Such a well-followed diet would allow to reduce by 20 the polyamines quantity present in the body.\n\nThe aim of this study is to evaluate whether a deficient polyamine diet introduced 7 days before and continued up to 7 days after an abdominal surgery requiring the use of morphine post-operatively reduces the post-operative pain, the consumption of analgesics (morphine) post-operatively and improve the recovery ability. Abdominals surgeries concerned will be the eventration cure and digestive continuity.\n\nThe medico-economic impact will be observed during this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult (\\>18 years)\n* Indication for a " major " abdominal surgery as second surgical procedure : cure of eventration and restoration of digestive continuity\n* Intended Use of a Patient Controlled Morphine Pump (PCA) postoperatively or taking oral opioids\n* Possible follow-up during 7 months (post-operative consultation at 1 month and 6 months only if postoperative pain or complications)\n* Written informed consent form obtained from the patient\n* Affiliated to the social security\n\nExclusion Criteria:\n\n* Pregnant women\n* Minor, adult under guardianship or benefiting from a legal protection\n* Oncological surgery\n* Surgery not painful (cholecystectomy, hernia, thyroidectomy, bariatric surgery)\n* Drug addicts patients, or under opiate dependency\n* Chronic pain patients (pain over 3 months)\n* Patients in nursing home or convalescence home (diet non possible in institution)\n* Planned hospitalisation before the intervention (during the 7 days before the surgery)\n* Severe undernutrition defined by the HAS criteria (weight loss \\> 10% in 1 month and/or \\> 15% in 6 months, albumin at inclusion \\<15g/l)\n* Patient refusing the possibility to change his eating habits\n* Oral feeding impossible preoperatively\n* Patient not able to express himself on their pain (silent, …)\n* Decompensated psychiatric pathologies (severe depression syndrome,…)\n* Patient unable to understand the protocol and/or to give his informed consent'}, 'identificationModule': {'nctId': 'NCT04219956', 'acronym': 'POLYAMAL', 'briefTitle': 'Study to Evaluate the Efficacy of a Polyamine-deficient Diet for Treating Postoperative Pain After Abdominal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'A Prospective Randomized Multicenter Study to Evaluate the Efficacy of a Polyamine-deficient Diet for the Treatment of Postoperative Pain After Abdominal Surgery.', 'orgStudyIdInfo': {'id': 'RC19_0023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Polyamine deficient diet', 'description': 'Diet low in polyamines: the estimated calculated dose is 20 times lower that in an usual diet', 'interventionNames': ['Other: Polyamine Deficient Diet']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Usual Diet plus two snacks'}], 'interventions': [{'name': 'Polyamine Deficient Diet', 'type': 'OTHER', 'description': 'Diet low in polyamines: the estimated calculated dose is 20 times lower that in an usual diet', 'armGroupLabels': ['Polyamine deficient diet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Brest', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jérémie Thereaux, MD PhD', 'role': 'CONTACT'}], 'facility': 'CHRU Brest La Cavale Blanche', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '92700', 'city': 'Colombes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'David MOSZKOWICZ, Pr', 'role': 'CONTACT', 'email': 'david.moszkowicz@aphp.fr'}], 'facility': 'Hôpital Louis Mourier from Ap-HP', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}, {'city': 'La Roche-sur-Yon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emeric Abet', 'role': 'CONTACT'}], 'facility': 'CHD Vendée', 'geoPoint': {'lat': 46.66974, 'lon': -1.42757}}, {'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Blanchard Claire, MD PhD', 'role': 'CONTACT'}, {'name': 'Tristan Greilsamer, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU Nantes Hôtel Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'centralContacts': [{'name': 'Claire Blanchard, MD-PhD', 'role': 'CONTACT', 'email': 'claire.blanchard@chu-nantes.fr', 'phone': '+33 (0)2 40 08 30 22'}, {'name': 'Laetitia Berly', 'role': 'CONTACT', 'email': 'laetitia.berly@chu-nantes.fr', 'phone': '+33 (0)2.53.52.62.04'}], 'overallOfficials': [{'name': 'Claire Blanchard, MD-PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nantes University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre de Recherche en Nutrition Humaine Ouest (CRNH)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}