Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT04972994
Status:
UNKNOWN
Last Update Posted:
2021-07-22
First Post:
2021-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Colectomies In Management of Colonic Cancers
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': 'right and left hemicolectomies in colonic cancers'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-21', 'studyFirstSubmitDate': '2021-07-06', 'studyFirstSubmitQcDate': '2021-07-21', 'lastUpdatePostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intraoperative time of surgery', 'timeFrame': 'intraoperative time of surgery', 'description': 'intraoperative time of surgery by minutes'}, {'measure': 'post operative hospital stay', 'timeFrame': 'up to 1 year', 'description': 'post operative hospital stay by days'}, {'measure': 'Post operative leakage', 'timeFrame': '1 year', 'description': 'Post operative leakage of anastomosis by follow up ultrasound, Abdominal Xray erect \\& wound infection'}, {'measure': 'early recurrence of the cancer', 'timeFrame': '6 months after surgery', 'description': 'early recurrence of the cancer by CT scan'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['laparoscopic', 'intracorporeal', 'extracorporeal', 'anastomosis', 'hemicolectomies', ', colonic cance'], 'conditions': ['Laparoscopic Colectomy', 'Cancer Colon', 'Intracorporeal Anastomosis']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare the Surgical outcomes after laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies in management of colonic cancers .', 'detailedDescription': 'This is clinical trial ,Interventional quasi experiment study to evaluate the surgical outcomes between intracorporeal versus extracorporeal anastomosis in laparoscopic right and left hemicolectomies including post operative pain, hospital stay, leakage from anastomosis, early recurrence, hernias patient satisfaction operative time and more surgical outcomes.\n\nIn Egyptian hospitals. Source of data the investigators follow up and medical reports and more . surgical procedures This trial including two groups of patients with right and left cancer colon undergoing Laparoscopic colectomy. First group (A) will be operated as intracorporeal anastomosis while the second group (B) will be operated as extracorporeal anastomosis.\n\nSample size more than 50 person Statistical analysis plan Statistical Package for the Social Sciences (SPSS) program'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients had to present histologically confirmed cancer( right and left) colon.\n* All grades of cancer will be included.\n* Cancer at cecum ,appendix, ascending colon, hepatic flexure or at splenic flexure , descending colon and sigmoid colon.\n\nExclusion Criteria:\n\n* Locally advanced disease with invasion of adjacent important organs.\n* Acute bowel obstruction or perforation from cancer.\n* Pregnant ladies.\n* Rectal cancer and transverse colon cancer.'}, 'identificationModule': {'nctId': 'NCT04972994', 'briefTitle': 'Laparoscopic Colectomies In Management of Colonic Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Surgical Outcomes After Laparoscopic Intracorporeal Versus Extracorporeal Anastomosis for Right and Left Hemicolectomies In Management of Colonic Cancers', 'orgStudyIdInfo': {'id': 'Soh-Med206018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'laparoscopic intracorporeal anastomosis for right and left hemicolectomies', 'description': 'Surgical outcomes after laparoscopic intracorporeal versus for right and left hemicolectomies in management of colonic cancers', 'interventionNames': ['Procedure: laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'laparoscopic extracorporeal anastomosis for right and left hemicolectomies', 'description': 'Surgical outcomes after laparoscopic extracorporeal anastomosis for right and left hemicolectomies in management of colonic cancers', 'interventionNames': ['Procedure: laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies']}], 'interventions': [{'name': 'laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies', 'type': 'PROCEDURE', 'description': 'laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies in management of colonic cancers', 'armGroupLabels': ['laparoscopic extracorporeal anastomosis for right and left hemicolectomies', 'laparoscopic intracorporeal anastomosis for right and left hemicolectomies']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sohag', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Omar AS Al tabary, professor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Abd El-Aal AS Mahran, Assistant professor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ahmed A Aldardeer, Lecturer', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ahmed Farag, professor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Sohag University Hospital', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Abdullah AA Abdullah, M.B.B.Ch,M.Sc', 'role': 'CONTACT', 'email': 'abdallah.attia@med.sohag.edu.eg', 'phone': '01060105272', 'phoneExt': '0114386363'}, {'name': 'Omar AS AlTabary, professor', 'role': 'CONTACT', 'phone': '01001164704'}], 'overallOfficials': [{'name': 'Omar AS Al tabary, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sohag University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecture general surgery', 'investigatorFullName': 'Abdullah Atyah Ali', 'investigatorAffiliation': 'Sohag University'}}}}