Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2026-01-01 @ 11:56 PM
Study NCT ID:
NCT02113995
Status:
COMPLETED
Last Update Posted:
2014-04-15
First Post:
2014-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation, Organic Response in Obesity Patients Subjected to Vertical Videolaparoscopy Gastroplasty With or Without Perioperative Cares Recommended by the Acerto Project. Randomized Study.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D009767', 'term': 'Obesity, Morbid'}, {'id': 'D000210', 'term': 'Acute-Phase Reaction'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-14', 'studyFirstSubmitDate': '2014-04-12', 'studyFirstSubmitQcDate': '2014-04-14', 'lastUpdatePostDateStruct': {'date': '2014-04-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ACERTO protocol', 'timeFrame': '6 months', 'description': 'To evaluate clinical results, insulin resistance and inflammatory response to trauma in morbidly obese patients undergoing laparoscopic Sleeve gastrectomy who received either traditional preoperative care or treatment following the ACERTO protocol.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Obesity, Morbid', 'Insulin Resistance', 'Acute-Phase Reaction', 'Gastroplasty', 'Length of Stay', 'Protocols', 'Randomized Controlled Trial.'], 'conditions': ['To Evaluate Clinical Results, Insulin Resistance and Inflammatory Response to Trauma in Morbidly Obese Patients']}, 'descriptionModule': {'briefSummary': 'Background To evaluate clinical results, insulin resistance and inflammatory response to trauma in morbidly obese patients undergoing laparoscopic Sleeve gastrectomy who received either traditional preoperative care or treatment following the ACERTO protocol.', 'detailedDescription': 'Methods The population of the study consisted of morbidly obese patients, who were operated on with the Sleeve procedure, from Cuiaba, MT, between April and October 2012. We studied the inflammatory response and insulin resistance by measuring levels of glucose, insulin, Homa IR, reactive C protein, albumin, pre-albumin, alpha 1 acid glicoprotein, interleukin 6 and glycosylated hemoglobin. We also studied hydration, nausea and vomiting, hypertension, and length of hospital stay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria: We included patients who are between 18 and 45 years of age, from both sexes, with an initial BMI (Body Mass Index) which is equal to or greater than 40 kg/m2, candidates for the sleeve surgery procedure through laparoscopy.\n\n\\-\n\nExclusion Criteria: We excluded the patients who didn't follow the fasting protocol and also those whose laboratory exams were lost.\n\n\\-"}, 'identificationModule': {'nctId': 'NCT02113995', 'briefTitle': 'Clinical Evaluation, Organic Response in Obesity Patients Subjected to Vertical Videolaparoscopy Gastroplasty With or Without Perioperative Cares Recommended by the Acerto Project. Randomized Study.', 'organization': {'class': 'OTHER', 'fullName': 'Cuiaba University'}, 'officialTitle': 'Clinical Evaluation, Organic Response in Obesity Patients Subjected to Vertical Videolaparoscopy Gastroplasty With or Without Perioperative Cares Recommended by the Acerto Project.', 'orgStudyIdInfo': {'id': '018/CEP-UNIC/2011.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'ACERTO', 'description': 'Patients received 400 ml of a beverage containing water and 50 g of maltodextrin 6 hours before the operation. They received orally extra 200 ml of this beverage containing water and 25 g of maltodextrin 3 hours before the operation. Regarding the intravenous fluids, they received 1 to 1.5 liter of crystalloid fluids (ringer lactate) in the intraoperative. In the immediate postoperative they were programmed to receive 2 liters of crystalloid fluids (ringer lactate) and 1 to 2 liters in the first day of the postoperative period. The venous hydration was suspended as soon as they started to drink liquids.\n\nProphylaxis of nausea and vomiting with dexamethasone 8 mg at the beginning of the anesthesia and ondansetron 4-8 mg after the surgery. In the postoperative period we utilized analgesics such as dipyrone and ketorolac and, if necessary, low doses of morphine and antiemetics like ondansetron.', 'interventionNames': ['Other: ACERTO protocol vs Traditional care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Traditional care', 'description': 'The analgesia in the postoperative period of the group control was performed with dipyrone, tramadol hydrochloride, and morphine. The prophylaxis of nausea and vomiting with dexamethasone 8 mg in the beginning of the anesthesia and the metoclopramide at the end of the surgery. During the anesthetic induction antibiotic prophylaxis (cefazolin 3 grams/day for 2 days) was administrated.\n\nThe control group were submitted to the protocol of traditional fasting with at least 8 hours. Patients in this group received 1 to 2 liters of crystalloid fluid (ringer lactate) in the intraoperative, and they received 3 to 4 liters of crystalloid fluids (ringer lactate, saline 0.9% and/or dextrose 5%). In the immediate postoperative, 2 to 3 liters in the first day of postoperative and, finally, 1 to 2 liters in the second day of the postoperative.', 'interventionNames': ['Other: ACERTO protocol vs Traditional care']}], 'interventions': [{'name': 'ACERTO protocol vs Traditional care', 'type': 'OTHER', 'description': 'Three sample blood collections were performed, being one in the anesthesic induction and the others in the next 24 to 48 hours. The blood was sent to the laboratory for dosages of glucose, insulin, C-reactive protein, albumin, prealbumin, alpha 1 acid glycoprotein and interleukin 6. During the anesthesic induction we also collected blood for analize glycosylated hemoglobin.', 'armGroupLabels': ['ACERTO', 'Traditional care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78000000', 'city': 'Cuiabá', 'state': 'Mato Grosso', 'country': 'Brazil', 'facility': 'ACERTO protocol', 'geoPoint': {'lat': -15.59611, 'lon': -56.09667}}], 'overallOfficials': [{'name': 'Gunther P Pimenta, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cuiaba University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cuiaba University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD Gunther Peres Pimenta', 'investigatorFullName': 'Gunther Peres Pimenta', 'investigatorAffiliation': 'Cuiaba University'}}}}