Ignite Creation Date:
2025-12-25 @ 3:40 AM
Ignite Modification Date:
2026-03-01 @ 1:44 PM
Study NCT ID:
NCT05421702
Status:
UNKNOWN
Last Update Posted:
2022-12-14
First Post:
2022-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between Results of 2 Laparoscopic Surgical Procedures in Operable Colon Cancer Cases in Upper Egypt
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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Operable colon cancer cases'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-13', 'studyFirstSubmitDate': '2022-06-13', 'studyFirstSubmitQcDate': '2022-06-13', 'lastUpdatePostDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative lymph node status', 'timeFrame': '2 weeks postoperative', 'description': 'Histopathological examination of the resected colon with lymph node status and number'}, {'measure': 'Postoperative histopathological result', 'timeFrame': '2 weeks postoperative', 'description': 'Type of the colon cancer'}, {'measure': 'Occurence of anastomotic leak', 'timeFrame': 'within 4 weeks postoperative', 'description': 'Yes/No'}, {'measure': 'Amount of anastomotic leak', 'timeFrame': 'within 4 weeks postoperative', 'description': 'Amount in cubic cm and nature of it with its management'}, {'measure': 'Intraoperative visceral injury type', 'timeFrame': 'Intraoperative reporting', 'description': 'Yes/No and its type'}, {'measure': 'Intraoperative visceral injury management', 'timeFrame': 'Intraoperative reporting', 'description': 'How managed'}, {'measure': 'Postoperative complications', 'timeFrame': '4 weeks postoperative', 'description': 'Yes/No with Reporting the postoperative complications; according to the Clavien-Dindo Grading System'}, {'measure': 'Operative time', 'timeFrame': 'Reporting immediately postoperative (at end of operation)', 'description': 'Reporting operative time with measurements in minutes'}, {'measure': 'Intraoperative vascular injury', 'timeFrame': 'Intraoperative', 'description': 'Yes/No with measurement in Cubic Cm and how managed'}, {'measure': 'Intraoperative blood loss', 'timeFrame': 'Intraoperative', 'description': 'Yes/No with measurement in Cubic Cm'}, {'measure': 'Resection margins in postoperative histopathological status', 'timeFrame': '2 weeks postoperative', 'description': 'Free or invaded'}, {'measure': 'Postoperative peritonitis', 'timeFrame': '4 weeks postoperative', 'description': 'Cause and how to manage?'}, {'measure': 'Colon cancer stage', 'timeFrame': '2 weeks Preoperative', 'description': 'According to primary tumor, regional nodes, metastasis (TNM) staging system'}, {'measure': 'Postoperative faecal fistula', 'timeFrame': '12 weeks postoperative', 'description': 'Reporting Yes/No with amount in cm3 and management'}, {'measure': 'length of resected mesocolon', 'timeFrame': '2 weeks postoperative', 'description': 'In cm'}, {'measure': 'Urological complications', 'timeFrame': 'Intraoperative and 4 weeks postoperative', 'description': 'Type and management'}, {'measure': 'Carcinoembryonic antigen (CEA) level', 'timeFrame': '2 weeks preoperative', 'description': 'Carcinoembryonic antigen (CEA) level by ng/mL'}, {'measure': 'Type of anastomosis', 'timeFrame': 'Intraoperative', 'description': 'Type of anastomosis (intra- or extracorporeal)'}], 'secondaryOutcomes': [{'measure': 'Age', 'timeFrame': 'preoperative', 'description': 'In years'}, {'measure': 'Preoperative haemoglobin level', 'timeFrame': 'preoperative', 'description': 'measured by g/dl'}, {'measure': 'Type of colonic anastomosis', 'timeFrame': 'Intraoperative', 'description': 'Stapler or hand sewing'}, {'measure': 'Preoperative histopathological result', 'timeFrame': '2 weeks preoperative', 'description': 'Histopathological examination'}, {'measure': 'Neoadjuvant therapy', 'timeFrame': '2 weeks Preoperative', 'description': 'Type of the neoadjuvant and duration'}, {'measure': 'Site of cancer colon', 'timeFrame': '2 weeks preoperative', 'description': 'cecum, appendix, ascending colon, hepatic flexure or at splenic flexure, transverse and descending colon and sigmoid colon'}, {'measure': 'Neurological complications', 'timeFrame': '4 weeks postoperative', 'description': 'Type and management'}, {'measure': 'Preoperative preparation', 'timeFrame': '3 days Preoperative', 'description': 'Mechanical and/or chemical'}, {'measure': 'Cardiopulmonary complications', 'timeFrame': '4 weeks postoperative', 'description': 'Yes/No Cardiopulmonary complications type and how managed'}, {'measure': 'Conversion to open surgery', 'timeFrame': 'intraoperative', 'description': 'Yes/No with the cause'}, {'measure': 'application of subcutaneous suction', 'timeFrame': '1 week Postoperative', 'description': 'Yes/No'}, {'measure': 'Average daily amount in subcutaneous suction', 'timeFrame': '2 weeks Postoperative', 'description': 'in Milliliters'}, {'measure': 'Average daily amount in intraperitoneal drain', 'timeFrame': '2 weeks Postoperative', 'description': 'in Milliliters'}, {'measure': 'Wound infection', 'timeFrame': '2 weeks postoperative', 'description': 'Yes/No and how managed'}, {'measure': 'Postoperative ileus', 'timeFrame': '2 weeks postoperative', 'description': 'Postoperative ileus Yes/No'}, {'measure': 'Hospital stay', 'timeFrame': '4 weeks postoperative', 'description': 'In days'}, {'measure': 'Wound dehiscence', 'timeFrame': '4 weeks postoperative', 'description': 'Yes/No'}, {'measure': 'Preoperative colonoscopic examination result', 'timeFrame': '2 weeks preoperative', 'description': 'mass/ulcer'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colon cancer', 'Colectomy', 'Mesocolic', 'Conventional', 'Laparoscopic', 'Surgical', 'Pathological'], 'conditions': ['Colon Cancer Stage I', 'Colon Cancer Stage II']}, 'descriptionModule': {'briefSummary': 'The investigators will assess and compare Surgical, pathological and oncological outcomes between two laparoscopic procedures conventional colectomy versus complete mesocolic excision for operable colon cancer cases in Upper Egypt', 'detailedDescription': 'Colon cancer is considered a huge clinical surgical burden accounting for 10% of cancer cases and deaths all over the world with consideration that surgery and adjuvant chemotherapy(if indicated) are the main lines of treatment .\n\nWhen Werner Hohenberger and colleagues described complete mesocolic excision (CME) in 2009; resection along the embryological and lymphovascular planes with appropriate resection margins, they did it for years before describing it with suggestion of improved disease outcomes and overall survival compared to the conventional colectomy (CC).\n\nThe principles of CME were described after the significant improvement of rectal adenocarcinoma surgical outcomes with establishment of total mesorectal excision (TME) in which tumor resection is associated with dissection of mesorectal fascial embryologic and lymphovascular planes.\n\nCME includes the same principles of the CC with maximizing lymph node dissection level into (D3 extended lymphadenectomy instead of D1 and D2 in conventional colectomy) and central vascular ligation (CVL) of the main feeding vessel(s) at their origin, with suggested improved disease-free and overall survival with suggested superior pathological and oncological results in the specimen.\n\nSome surgeons consider that CME; with D3 extended lymphadenectomy and CVL is the optimal or standard surgical method in primary cancer colon based on suggested reduced local recurrence and improved disease-free and overall survival.\n\nAlthough CME has a theoretical advantages and promising early results, it is not widely adopted as the standard in some areas. CME is technically more demanding than CC and suggested to be associated with more intraoperative visceral injuries and non-surgical complications and many doubts persist about safety and efficacy of the procedure.\n\nThe questions of interest and research, should CME be regarded as the optimal procedure for colon cancer cases? And also another question; is conventional colectomy suboptimal?'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Both sexes will be included.\n2. Age: all adult patients.\n3. All diagnosed patients with operable cancer colon.\n4. Cancer at cecum, appendix, ascending colon, hepatic flexure or at splenic flexure, transverse and descending colon and sigmoid colon.\n5. Fit patients.\n\nExclusion Criteria:\n\n1. Irresectable colon cancer.\n2. Inoperable colon cancer.\n3. Rectal cancer.\n4. Unfit patients.'}, 'identificationModule': {'nctId': 'NCT05421702', 'briefTitle': 'Comparison Between Results of 2 Laparoscopic Surgical Procedures in Operable Colon Cancer Cases in Upper Egypt', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Surgical, Pathological and Oncological Outcomes of Laparoscopic Conventional Colectomy Versus Complete Mesocolic Excision for Operable Colon Cancer Cases in Upper Egypt', 'orgStudyIdInfo': {'id': 'Soh-Med-22-06-17'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A Operable colon cancer cases', 'description': 'All patients with operable colon cancer who will undergo laparoscopic conventional colectomy', 'interventionNames': ['Procedure: laparoscopic conventional colectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B Operable colon cancer cases', 'description': 'All patients with operable colon cancer who will undergo laparoscopic complete mesocolic excision', 'interventionNames': ['Procedure: laparoscopic complete mesocolic excision']}], 'interventions': [{'name': 'laparoscopic conventional colectomy', 'type': 'PROCEDURE', 'otherNames': ['D2 colectomy'], 'description': 'Laparoscopic colectomy with only lymph node dissection up to level 2 lymph nodes D2.', 'armGroupLabels': ['Group A Operable colon cancer cases']}, {'name': 'laparoscopic complete mesocolic excision', 'type': 'PROCEDURE', 'description': 'Laparoscopic colectomy with lymphovascular dissection from level 3 lymph nodes or more D3.', 'armGroupLabels': ['Group B Operable colon cancer cases']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82524', 'city': 'Sohag', 'country': 'Egypt', 'facility': 'Sohag faculty of medicine', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'overallOfficials': [{'name': 'Ahmed E Ahmed, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Sohag University'}, {'name': 'Mena Z Helmy, Ass prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sohag University'}, {'name': 'Mostafa F Mohammed, Ass lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sohag University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'It is not yet known if there will be a plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer of general surgery', 'investigatorFullName': 'Mostafa Farrag Mohammed', 'investigatorAffiliation': 'Sohag University'}}}}