Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-31 @ 11:54 AM
Study NCT ID:
NCT04434508
Status:
COMPLETED
Last Update Posted:
2020-06-17
First Post:
2020-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open Versus Laparoscopic Right Hemicolectomy for Right 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Enrolled patients in the study were randomized to either laparoscopic or open right hemicolectomy with CME and central vascular ligation. The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Enrolled patients in the study were randomized to either laparoscopic or open right hemicolectomy with CME and central vascular ligation. The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-12', 'studyFirstSubmitDate': '2020-06-12', 'studyFirstSubmitQcDate': '2020-06-12', 'lastUpdatePostDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the number of lymph nodes (LNs) harvested among both groups', 'timeFrame': '30 DAYS', 'description': 'the number of lymph nodes (LNs) harvested among both groups'}], 'secondaryOutcomes': [{'measure': 'operative time', 'timeFrame': 'INTRAOPERATIVE', 'description': 'operative time'}, {'measure': 'blood loss,', 'timeFrame': 'intraoperative', 'description': 'blood loss,'}, {'measure': 'post-operative complications', 'timeFrame': '30 days', 'description': 'post-operative complications'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colonic Cancer', 'laparoscopic right hemicolectomy', 'complete mesocolic excision'], 'conditions': ['Colonic Cancer']}, 'referencesModule': {'availIpds': [{'id': 'Ayman El Nakeeb', 'url': 'http://www.mans.edu.eg/en/', 'type': 'Study Protocol', 'comment': 'elnakeebayman@yahoo.com'}], 'references': [{'pmid': '25072438', 'type': 'BACKGROUND', 'citation': 'Cho MS, Baek SJ, Hur H, Soh Min B, Baik SH, Kyu Kim N. Modified complete mesocolic excision with central vascular ligation for the treatment of right-sided colon cancer: long-term outcomes and prognostic factors. Ann Surg. 2015 Apr;261(4):708-15. doi: 10.1097/SLA.0000000000000831.'}, {'pmid': '32172577', 'type': 'RESULT', 'citation': 'Vajda K, Horti I, Cserni G, Bori R, Sikorszki L. [Laparoscopic and open complete mesocolic excision in right-sided colon cancer compared with open and laparoscopic surgery]. Magy Seb. 2020 Mar;73(1):23-28. doi: 10.1556/1046.73.2020.1.3. Hungarian.'}, {'pmid': '31243573', 'type': 'RESULT', 'citation': 'Dewulf M, Kalmar A, Vandenberk B, Muysoms F, Defoort B, Claeys D, Pletinckx P. Complete mesocolic excision does not increase short-term complications in laparoscopic left-sided colectomies: a comparative retrospective single-center study. Langenbecks Arch Surg. 2019 Aug;404(5):557-564. doi: 10.1007/s00423-019-01797-8. Epub 2019 Jun 26.'}, {'pmid': '26833471', 'type': 'RESULT', 'citation': 'Emmanuel A, Haji A. Complete mesocolic excision and extended (D3) lymphadenectomy for colonic cancer: is it worth that extra effort? A review of the literature. Int J Colorectal Dis. 2016 Apr;31(4):797-804. doi: 10.1007/s00384-016-2502-0. Epub 2016 Jan 30.'}], 'seeAlsoLinks': [{'url': 'http://www.mans.edu.eg/en/', 'label': 'Mansoura university'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to demonstrate the feasibility, surgical, and oncologic outcomes of laparoscopic right hemicolectomy with CME and CVL compared to open surgery.', 'detailedDescription': 'The aim of this study is to demonstrate the feasibility, surgical, and oncologic outcomes of laparoscopic right hemicolectomy with CME and CVL compared to open surgery.\n\nEnrolled patients in the study were randomized to either laparoscopic or open right hemicolectomy with CME and central vascular ligation. The randomization process was performed using a closed envelope method which was withdrawn in the outpatient clinic by a nurse.\n\nThe primary outcome was the number of lymph nodes (LNs) harvested among both groups. Secondary outcomes included operative time, blood loss, postoperative complications, and hospital stay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with right colonic cancer\n\nExclusion Criteria:\n\n* Patients with distant metastasis, large tumors with extra-colonic invasion emergency presentation (bowel obstruction or perforation)'}, 'identificationModule': {'nctId': 'NCT04434508', 'acronym': 'CME', 'briefTitle': 'Open Versus Laparoscopic Right Hemicolectomy for Right Colon Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Open Versus Laparoscopic Right Hemicolectomy With Complete Mesocolic Excision and Central Vascular Ligation for Right Colon Cancer. A Randomized Prospective Study.', 'orgStudyIdInfo': {'id': 'laparoscopic hemicolectomy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'laparoscopic right hemicolectomy with CME and central v', 'description': 'laparoscopic right hemicolectomy with CME and central v', 'interventionNames': ['Procedure: laparoscopic right hemicolectomy with CME and central v']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'open right hemicolectomy with CME and central v', 'description': 'open right hemicolectomy with CME and central v', 'interventionNames': ['Procedure: Open right hemicolectomy with CME and central v']}], 'interventions': [{'name': 'laparoscopic right hemicolectomy with CME and central v', 'type': 'PROCEDURE', 'otherNames': ['LHC with CME'], 'description': 'laparoscopic right hemicolectomy with CME and central v', 'armGroupLabels': ['laparoscopic right hemicolectomy with CME and central v']}, {'name': 'Open right hemicolectomy with CME and central v', 'type': 'PROCEDURE', 'otherNames': ['ORH with CME'], 'description': 'Open right hemicolectomy with CME and central v', 'armGroupLabels': ['open right hemicolectomy with CME and central v']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35111', 'city': 'Al Mansurah', 'state': 'Outside U.S and Canada', 'country': 'Egypt', 'facility': 'Ayman El Nakeeb', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Ayman E Nakeeb', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura University, Gastrointestinal Surgery Center'}, {'name': 'Mohamed E el sorogy, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mansoura University, Gastrointestinal Surgery Center'}]}, 'ipdSharingStatementModule': {'url': 'http://www.mans.edu.eg/en/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': '6 months', 'ipdSharing': 'YES', 'description': 'Study Protocol', 'accessCriteria': 'elnakeebayman@yahoo.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'gastrointestinal surgical center, Mansoura University', 'investigatorFullName': 'Ayman El Nakeeb', 'investigatorAffiliation': 'Mansoura University'}}}}