Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-02-23 @ 1:52 PM
Study NCT ID:
NCT02549456
Status:
UNKNOWN
Last Update Posted:
2017-03-24
First Post:
2015-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Natural Orifice Transluminal Endoscopic Surgery for Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'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'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2018-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-22', 'studyFirstSubmitDate': '2015-08-29', 'studyFirstSubmitQcDate': '2015-09-11', 'lastUpdatePostDateStruct': {'date': '2017-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility', 'timeFrame': '24 hour', 'description': 'Rate of conversion to classic laparoscopy or to open laparotomy.'}, {'measure': 'operative time', 'timeFrame': '24 hour', 'description': 'time taken from starting operation till patient wake up'}, {'measure': 'Operative blood loss', 'timeFrame': '24 hour', 'description': 'measured in milliliter'}, {'measure': 'Wound complications', 'timeFrame': 'two week', 'description': 'infection-dehiscence'}, {'measure': 'Major intraoperative complications', 'timeFrame': '24 hour', 'description': 'bleeding -organ injury'}, {'measure': 'Major postoperative complications', 'timeFrame': 'two weeks', 'description': 'leak-bleeding'}], 'secondaryOutcomes': [{'measure': 'Adequacy of lymphadenectomy', 'timeFrame': 'one month', 'description': 'Number of lymph nodes retrieved'}, {'measure': 'Grading of quality and completeness of mesorectal excision', 'timeFrame': 'one month', 'description': 'It is a composite outcome where result will appear as either complete, near complete or incomplete. Criteria in (shape, coning, presence of defects and circumferential safety margin) will be integrated to categorize it.'}, {'measure': 'Longitudinal safety margin', 'timeFrame': 'one month', 'description': 'either free or infiltrated with tumor by histopathology examination.'}, {'measure': 'short term oncologic outcome', 'timeFrame': '6 months - one year', 'description': 'incidence of local and distant outcomes and disease free survival'}, {'measure': 'Functional outcome', 'timeFrame': '3 months', 'description': "assessing fecal incontinence using Kirwan's grading score"}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['natural orifice surgery', 'natural orifice specimen extraction', 'taTME'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess different hybrid natural orifice transluminal endoscopic surgery techniques in management of colorectal cancer as regard: feasibility of the technique, short term oncologic outcome and functional outcome.', 'detailedDescription': 'Intervention will be done by conventional laparoscopy and transanal endoscopy (TEO or Gelpoint platform), patients are divided into two arms to compare different natural orifice techniques in resection of colorectal cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Medically fit patient.\n2. Non metastatic pathologically proven sigmoid colon cancer.\n3. Non metastatic pathologically proven rectal cancer.\n4. Patient continent for stool.\n\nExclusion Criteria:\n\n1. Patients with American Society of Anesthesiologist (ASA) score 4 and 5.\n2. Patients with cardiac or chest problems that cannot withstand insufflation.\n3. Unresectable tumors (defined as those who cannot be resected without a high likelihood of leaving microscopic or gross residual disease at the local site because of tumor adherence or fixation).\n4. Obstructed or perforated cancer.\n5. Patients with metastatic colorectal cancer.\n6. Incontinent patients.'}, 'identificationModule': {'nctId': 'NCT02549456', 'acronym': 'NOTES', 'briefTitle': 'Natural Orifice Transluminal Endoscopic Surgery for Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Natural Orifice Transluminal Endoscopic Surgery for Colorectal Cancer', 'orgStudyIdInfo': {'id': 'MD/148'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Natural orifice specimen extraction', 'description': 'Conventional laparoscopic resection of colorectal cancer with natural orifice specimen extraction', 'interventionNames': ['Procedure: natural orifice specimen extraction']}, {'type': 'EXPERIMENTAL', 'label': 'Laparoendoscopic resection', 'description': 'Laparoscopic assisted transanal endoscopic resection of rectal cancer', 'interventionNames': ['Procedure: Laparoendoscopic resection']}], 'interventions': [{'name': 'natural orifice specimen extraction', 'type': 'PROCEDURE', 'description': 'Conventional laparoscopic resection of colorectal cancer is done then specimen is extracted through natural orifice (anal or vaginal orifice).', 'armGroupLabels': ['Natural orifice specimen extraction']}, {'name': 'Laparoendoscopic resection', 'type': 'PROCEDURE', 'description': "Endoscopic phase: Transanal platform is inserted into the rectum, and pneumorectum is established. The lumen is occluded below the level of the tumor. The avascular ''oncologic'' presacral plane is entered posteriorly, and dissection proceeds cephalad in the total mesorectal excision planes. Next, the abdominal cavity is entered at the peritoneal reflection. The superior rectal artery is divided. The rectal stump then is reflected into the abdominal cavity, and retrograde dissection is performed until the procedure is limited by instrument length.\n\nLaparoscopic phase: Colon mobilization, lymph node dissection, and mesenteric excision are performed laparoscopically. Mobilization of the splenic flexure is done if needed.", 'armGroupLabels': ['Laparoendoscopic resection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35516', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Islam H Metwally, M.Sc', 'role': 'CONTACT', 'email': 'drislamhany@mans.edu.eg', 'phone': '01002985865', 'phoneExt': '02'}, {'name': 'Mohamed A Hegazy, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Waleed E Rashad, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Oncology center Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': 'Islam H Metwally, M.Sc', 'role': 'CONTACT', 'email': 'dr.islamo@hotmail.com', 'phone': '01002985865', 'phoneExt': '02'}], 'overallOfficials': [{'name': 'Jose F Noguira, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Head of general and digestive surgery department, CHUAC, universidade da Coruna'}, {'name': 'Sherif Z Kotb, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Professor of surgical oncology, Oncology center Mansoura University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Universidade da Coruña', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer of surgical oncology', 'investigatorFullName': 'Islam Hany Metwally', 'investigatorAffiliation': 'Mansoura University'}}}}