Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-02-24 @ 5:04 PM
Study NCT ID:
NCT02555020
Status:
COMPLETED
Last Update Posted:
2017-09-18
First Post:
2015-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Preoperative Oral Carbohydrates on Quality of Recovery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 153}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2016-12-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-15', 'studyFirstSubmitDate': '2015-09-11', 'studyFirstSubmitQcDate': '2015-09-18', 'lastUpdatePostDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Recovery score using the QoR-40 Questionnaire', 'timeFrame': 'We check the QoR-40 at POD1 after cholecystectomy , an expected average 3days', 'description': 'We check the QoR-40 Questionnaire at discharge day'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Evidence of Cholecystectomy']}, 'referencesModule': {'references': [{'pmid': '29915988', 'type': 'DERIVED', 'citation': 'Lee JS, Song Y, Kim JY, Park JS, Yoon DS. Effects of Preoperative Oral Carbohydrates on Quality of Recovery in Laparoscopic Cholecystectomy: A Randomized, Double Blind, Placebo-Controlled Trial. World J Surg. 2018 Oct;42(10):3150-3157. doi: 10.1007/s00268-018-4717-4.'}]}, 'descriptionModule': {'briefSummary': 'Carbohydrate loading is an important component of enhanced recovery pathways. Preoperative carbohydrate treatments have been widely adopted as part of enhanced recovery after surgery (ERAS) or fast-track surgery protocols. Although fast-track surgery protocols have been widely investigated and have been shown to be associated with improved postoperative outcomes, some individual constituents of these protocols, including preoperative carbohydrate treatment, have not been subject to such robust analysis.To assess the effects of preoperative carbohydrate treatment, compared with placebo or preoperative fasting, on postoperative recovery and insulin resistance in adult patients undergoing elective surgery.', 'detailedDescription': 'Patients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before anesthesia and 400 mL 2 hours before. CHL composition was standard: 12.5 g of carbohydrate per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50 kcal.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ASA (I/II)\n2. Laparoscopic cholecystectomy.\n3. KAROFSKY PERFORMANCE SCALE \\>70,\n4. No history of major operation\n\nExclusion Criteria:\n\n1. DM patients\n2. GE reflux Hx patients.\n3. No- compliance,\n4. Previous Abdominal Surgery History'}, 'identificationModule': {'nctId': 'NCT02555020', 'acronym': 'laparoscopy', 'briefTitle': 'Effect of Preoperative Oral Carbohydrates on Quality of Recovery', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Effect of Preoperative Oral Carbohydrates on Quality of Recovery: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '3-2015-0158'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Allocated to MN NPO group,', 'description': '1. Patients was administered in hospital\n2. Randomization\n3. Patient was allocated to MN group\n4. Patients were NPO from mid night (MN) to Surgery', 'interventionNames': ['Dietary Supplement: Allocated to MN NPO group,']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Allocated to Placebo group', 'description': '1. Patients was administered in hospital\n2. Randomization\n3. Patient was allocated to Placebo group\n4. Patients received 400 mL of water 12 hours before anesthesia and 400 mL 2 hours before anesthesia.', 'interventionNames': ['Dietary Supplement: Allocated to Placebo group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Allocated to Carbohydrated group', 'description': '1. Patients was administered in hospital\n2. Randomization\n3. Patient was allocated to Carbohydrated group\n4. Patients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before anesthesia and 400 mL 2 hours before. CHL composition was standard: 12.5 g of carbohydrate per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50 kcal.', 'interventionNames': ['Dietary Supplement: Allocated to Carbohydrated group']}], 'interventions': [{'name': 'Allocated to Carbohydrated group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before anesthesia and 400 mL 2 hours before. CHL composition was standard: 12.5 g of carbohydrate per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50 kcal.', 'armGroupLabels': ['Allocated to Carbohydrated group']}, {'name': 'Allocated to Placebo group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients received 400 mL of oral free water (Placebo) 12 hours before anesthesia and 400 mL 2 hours before.', 'armGroupLabels': ['Allocated to Placebo group']}, {'name': 'Allocated to MN NPO group,', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients received NPO from MN.', 'armGroupLabels': ['Allocated to MN NPO group,']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'GangNam Severance Hospital', 'investigatorFullName': 'Joon Seong Park', 'investigatorAffiliation': 'Yonsei University'}}}}