Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-26 @ 1:51 AM
Study NCT ID:
NCT03619759
Status:
COMPLETED
Last Update Posted:
2019-08-20
First Post:
2018-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Sugammadex on the Outcome After Colorectal Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011183', 'term': 'Postoperative Complications'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077122', 'term': 'Sugammadex'}], 'ancestors': [{'id': 'D047408', 'term': 'gamma-Cyclodextrins'}, {'id': 'D003505', 'term': 'Cyclodextrins'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003912', 'term': 'Dextrins'}, {'id': 'D013213', 'term': 'Starch'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 585}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-18', 'studyFirstSubmitDate': '2018-07-10', 'studyFirstSubmitQcDate': '2018-08-02', 'lastUpdatePostDateStruct': {'date': '2019-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of stay', 'timeFrame': 'admission to discharge (within 1 month)', 'description': 'Length of stay in hospital'}], 'secondaryOutcomes': [{'measure': 'Readmission rate', 'timeFrame': '30 days after discharge', 'description': 'Readmission or ER visit within 30 days after discharge'}, {'measure': 'postoperative complication rate', 'timeFrame': 'after colorectal surgery, within 30 days', 'description': 'postoperative complications, heart, lung, kidney, neurovascular, infection etc Check by review discharge summary note, consultation note, and postoperative laboratory tests'}, {'measure': 'Time to first successful oral intake', 'timeFrame': 'within 30 days', 'description': 'time interval between end of surgery and the first successful oral intake'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sugammadex', 'Colorectal surgery', 'postoperative complication'], 'conditions': ['Outcome, Fatal']}, 'descriptionModule': {'briefSummary': 'This study is retrospective study. The purpose of this study is checking the effect of sugammadex on the outcome after colorectal surgery. The outcome is compared among the 2 groups, sugammadex group and non-sugammadex group. The primary parameters of outcome are length of stay, readmission rate, postoperative complications, time interval for first successful oral intake.', 'detailedDescription': "Abdominal surgery, like colorectal surgery, needs more than moderate neuromuscular block during surgery. After the surgery, reversal agent of neuromuscular blocking agent is given almost every pateints who underwent general anesthesia.\n\nClassic reversal agent is cholinesterase inhibitor, like pyridostigmine and neostigmine. Its action mechanism is competetive antagonist of rocuronium. But cholinesterase inhibitor cannot make complete reversal in moderate or deep neuromuscular block. Its incomplete reversal which is called residual block cause respiratory complications and prolongation hospital stay.\n\nSugammadex has different mechanism compared to cholinesterase inhibitor. It captures neuromuscular agent, especially rocuronium, and prevent rocuronium's action. Even in deep neuromuscular block, sugammadex can reverse the action of rocuronium, and its reversal effect is fater and more reliable compared to cholinesterase inhibitor.\n\nPrevious studies focused on only short term outcome of sugammadex, like postanesthetic care unit (PACU) discharge time, respiratory complications in PACU.\n\nBut in this study, longer term outcome will be comapred between sugammadex group and cholinesterase inhibitor group (pyridostigmine)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 21 and 80 years old, who took the colorectal surgery due to colorectal cancer from Jan, 2012 to Dec, 2017', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects aged 21\\~80\n* Subjects who took colorectal surgery due to colon or rectal cancer from Jan, 2012 to Dec, 2017\n\nExclusion criteria\n\n* Emergency surgery\n* Paraplegia or quadriplegia\n* Bedridden state d/t various reason\n* Neuromuscular disease\n* Combined operation wth other surgery'}, 'identificationModule': {'nctId': 'NCT03619759', 'acronym': 'Sugammadex', 'briefTitle': 'The Effect of Sugammadex on the Outcome After Colorectal Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ajou University School of Medicine'}, 'officialTitle': 'The Effect of Sugammadex on the Outcome After Colorectal Cancer Surgery', 'orgStudyIdInfo': {'id': 'AJIRB-MED-MDB-18-36'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sugammadex', 'description': 'Patients who used sugammadex Sugammadex 1 vial (200mg) intravenous, at the end surgery, before extubation', 'interventionNames': ['Drug: Sugammadex']}, {'label': 'Non-sugammadex', 'description': "Patients who didn't use sugammadex Pyridostigmine 15\\~20mg intravenous, at the end of surgery, before extubation"}], 'interventions': [{'name': 'Sugammadex', 'type': 'DRUG', 'otherNames': ['Bridion'], 'description': 'Sugammadex injection as a reverse agent of neuromuscular blocking', 'armGroupLabels': ['Sugammadex']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16377', 'city': 'Suwon', 'state': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Ajou university school of medicine', 'geoPoint': {'lat': 37.29111, 'lon': 127.00889}}], 'overallOfficials': [{'name': 'In Kyong Yi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ajou University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ajou University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical assistant professor', 'investigatorFullName': 'In-kyong Yi', 'investigatorAffiliation': 'Ajou University School of Medicine'}}}}