Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-01-24 @ 7:58 PM
Study NCT ID:
NCT02553551
Status:
UNKNOWN
Last Update Posted:
2016-10-18
First Post:
2015-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Vitamin C on Postoperative Pain After Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002769', 'term': 'Cholelithiasis'}], 'ancestors': [{'id': 'D001660', 'term': 'Biliary Tract Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001205', 'term': 'Ascorbic Acid'}, {'id': 'D014815', 'term': 'Vitamins'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D018977', 'term': 'Micronutrients'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D000078622', 'term': 'Nutrients'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 320}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-17', 'studyFirstSubmitDate': '2015-09-13', 'studyFirstSubmitQcDate': '2015-09-16', 'lastUpdatePostDateStruct': {'date': '2016-10-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The postoperative pain', 'timeFrame': 'The change of pain score between 6hours after operation and 24hours after operation', 'description': 'Postoperative pain was estimated using the visual analog scale (VAS) from 0 (no pain) to 10 (worst pain imaginable) at 6, 24, and 48 hours after the operation.'}], 'secondaryOutcomes': [{'measure': 'Postoperative morbidity', 'timeFrame': '30 days', 'description': 'the incidence of complications after surgery during one month after surgery such as postoperative fever, atelectasis, infectious complications, bile leak, postoperative bleeding, readmission or mortality.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Cholecystitis', 'Cholelithiasis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effect of Vitamine C supplements to be helpful to reduce the postoperative pain after laparoscopic cholecystectomy through the double-blinded randomized controlled trial.', 'detailedDescription': 'The aim of this study is to evaluate the effect of Vitamine C supplements to be helpful to reduce the postoperative pain after laparoscopic cholecystectomy through the double-blinded randomized controlled trial.\n\nThe primary purpose of this study is to confirm the reduce of postoperative pain through the oral supplement of Vitamine C before and after the surgery. For this purpose, we compared the dosage or counts of opioids usage with the oral supplement of Vitamine C or not.\n\nThe secondary purpose is to assess the pain score, postoperative morbidities, postoperative length of stay or postoperative time between two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic cholecystitis\n* gallbladder polyp\n\nExclusion Criteria:\n\n* grade I Tokyo guideline for acute cholecystitis\n* grade II Tokyo guideline for acute cholecystitis without the evidence of gallbladder perforation\n* gallbladder cancer\n* the patient who underwent reduced port surgery\n* the patient who underwent common bile duct exploration during the operation\n* the patient who underwent concurrent operation\n* the patient who had past history of upper abdominal surgery\n* the patient who had a immunodeficiency state\n* the case which had a suspicion of delayed bile leakage\n* the case which had a incomplete cystic duct ligation\n* the patient who underwent open conversion surgery during the operation\n* the patient who had a high risk of bleeding'}, 'identificationModule': {'nctId': 'NCT02553551', 'briefTitle': 'Effect of Vitamin C on Postoperative Pain After Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': "Seoul St. Mary's Hospital"}, 'officialTitle': 'Effect of Vitamin C on Postoperative Pain After Laparoscopic Cholecystectomy; a A Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Seoul-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vitamin C', 'description': 'During the period of hospitalization, Intake of vitamin C 3000 mg per day via oral route until the day of discharge.\n\nAfter discharge, no additional vitamin C pill was given.', 'interventionNames': ['Drug: Vitamin C']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'During the period of hospitalization, Intake of gelatinous capsule three times per day via oral route until the day of discharge.\n\nAfter discharge, no additional capsule was given.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Vitamin C', 'type': 'DRUG', 'otherNames': ['Vitamin'], 'description': 'During the period of hospitalization, Intake of vitamin C 3000 mg per day via oral route until the day of discharge.\n\nAfter discharge, no additional vitamin C pill was given.', 'armGroupLabels': ['Vitamin C']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['placebo capsule'], 'description': 'During the period of hospitalization, Intake of gelatinous capsule three times per day via oral route until the day of discharge.\n\nAfter discharge, no additional capsule was given.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '137-701', 'city': 'Seoul', 'state': 'Seocho-gu, Banopo-dong', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Taeho Hong', 'role': 'CONTACT', 'email': 'gshth@catholic.ac.kr', 'phone': '+82-2-2258-6108'}], 'facility': "Department of HBP Surgery, Seoul St. Mary's hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Taeho Hong', 'role': 'CONTACT', 'email': 'gshth@catholic.ac.kr', 'phone': '821052065266'}], 'overallOfficials': [{'name': 'Taeho Hong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seoul St. Mary's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taeho Hong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Taeho Hong', 'investigatorAffiliation': "Seoul St. Mary's Hospital"}}}}