Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-31 @ 10:02 AM
Study NCT ID:
NCT01203969
Status:
COMPLETED
Last Update Posted:
2016-02-03
First Post:
2010-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Single Port Laparoscopic Surgery in Colon Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 62}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-02', 'studyFirstSubmitDate': '2010-09-15', 'studyFirstSubmitQcDate': '2010-09-16', 'lastUpdatePostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-09-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of intraoperative complication', 'timeFrame': '1 day'}, {'measure': 'rate of 30 day morbidity and mortality', 'timeFrame': '1 month'}], 'secondaryOutcomes': [{'measure': 'operation time', 'timeFrame': '1 day', 'description': 'operative time'}, {'measure': 'degree of postoperative pain', 'timeFrame': '5 days', 'description': 'postoperative pain score using visual analog scale (VAS)'}, {'measure': 'amount of postoperative analgesics usage', 'timeFrame': '5 days'}, {'measure': 'postoperative functional recovery', 'timeFrame': '7 days', 'description': 'time to first passage of flatus time to start diet'}, {'measure': 'Duration of postoperative hospital stay', 'timeFrame': '7 days'}]}, 'conditionsModule': {'conditions': ['Colon Cancer']}, 'referencesModule': {'references': [{'pmid': '28061037', 'type': 'DERIVED', 'citation': 'Kang BM, Park SJ, Lee KY, Lee SH. Single-Port Laparoscopic Surgery Can Be Performed Safely and Appropriately for Colon Cancer: Short-Term Results of a Pilot Randomized Controlled Trial. J Laparoendosc Adv Surg Tech A. 2017 May;27(5):501-509. doi: 10.1089/lap.2016.0467. Epub 2017 Jan 6.'}]}, 'descriptionModule': {'briefSummary': 'This randomized trial is designed to identify the safety and efficacy of single port laparoscopic surgery in colon cancer compared with conventional laparoscopic surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pathologic proven colon cancer\n\nExclusion Criteria:\n\n* Tumor located in distal transverse colon, splenic flexure, and descending colon\n* distant metastasis\n* acute obstruction and/or perforation\n* associated with FAP or HNPCC\n* synchronous malignancy\n* ASA score 3 or 4\n* pregnancy\n* no consent'}, 'identificationModule': {'nctId': 'NCT01203969', 'briefTitle': 'Safety and Efficacy of Single Port Laparoscopic Surgery in Colon Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Kyunghee University Medical Center'}, 'orgStudyIdInfo': {'id': 'KHNMC IRB 2010-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single port laparoscopic surgery', 'interventionNames': ['Procedure: Single port laparoscopic surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional laparoscopic surgery', 'interventionNames': ['Procedure: Conventional laparoscopic surgery']}], 'interventions': [{'name': 'Single port laparoscopic surgery', 'type': 'PROCEDURE', 'description': 'laparoscopic surgery in which all the instrument was entered into the abdominal cavity through the single port in the umbilicus', 'armGroupLabels': ['Single port laparoscopic surgery']}, {'name': 'Conventional laparoscopic surgery', 'type': 'PROCEDURE', 'description': 'laparoscopic surgery in which each of the instrument were entered into the abdominal cavity through the multiple port in multiple quadrants of abdomen', 'armGroupLabels': ['Conventional laparoscopic surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '134-727', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee University School of Medicine, Neo Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Suk Hwan Lee, MD. PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyung Hee University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyunghee University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Byung Mo Kang', 'investigatorAffiliation': 'Kyunghee University Medical Center'}}}}