Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-25 @ 8:27 PM
Study NCT ID:
NCT03499769
Status:
COMPLETED
Last Update Posted:
2018-07-20
First Post:
2018-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison of NOSE and Conventional Methods in Laparoscopic Total Colon Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072836', 'term': 'Surgical Wound'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D057605', 'term': 'Natural Orifice Endoscopic Surgery'}, {'id': 'D003226', 'term': 'Congresses as Topic'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-18', 'studyFirstSubmitDate': '2018-03-27', 'studyFirstSubmitQcDate': '2018-04-09', 'lastUpdatePostDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Score', 'timeFrame': '240 days', 'description': 'Visual Analog Score for pain (1-10 score)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgical Incision']}, 'descriptionModule': {'briefSummary': 'Laparoscopic total colectomy (LTC) is an accepted surgical procedure for several colonic pathologies. Additionally, specimen extraction through the natural orifices is an emerging method when combined with the totally laparoscopic procedures. Our observations on natural orifice surgery was promising . In our daily surgical practice, investigators prefer the intracorporeal anastomosis and this study was conducted to compare the specimen extraction sites after LTC. Here investigators aimed to compare the results of conventional and natural orifice specimen extractions (NOSE) after totally LTCs.', 'detailedDescription': 'compare the patient-selected NOSE method and conventional method in laparoscopic total colon surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* laparoscopic total colectomy patients\n\nExclusion Criteria:\n\n* no'}, 'identificationModule': {'nctId': 'NCT03499769', 'briefTitle': 'Comparison of NOSE and Conventional Methods in Laparoscopic Total Colon Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Inonu University'}, 'officialTitle': 'Comparison of NOSE and Conventional Methods in Laparoscopic Total Colon Surgery', 'orgStudyIdInfo': {'id': '2018/3-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'natural orifice', 'description': 'Patients who underwent laparoscopic surgery and removed the specimen from the natural orifice will be gathered. demographic data and perioperative results will be compiled', 'interventionNames': ['Procedure: natural orifice']}, {'type': 'NO_INTERVENTION', 'label': 'conventional', 'description': 'patients who underwent laparoscopic surgery and removed specimen with conventional will be gathered. demographic data and perioperative results will be compiled. (conventional extraction is suprapubic or median incision)'}], 'interventions': [{'name': 'natural orifice', 'type': 'PROCEDURE', 'otherNames': ['conventional'], 'description': 'laparoscopic total colon surgery and patients who are removed from the natural orifice and conventional will gather', 'armGroupLabels': ['natural orifice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44090', 'city': 'Malatya', 'country': 'Turkey (Türkiye)', 'facility': 'Inonu University', 'geoPoint': {'lat': 38.35018, 'lon': 38.31667}}], 'overallOfficials': [{'name': 'Ersin Gündoğan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inonu Unıversity- general surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inonu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'operator doctor', 'investigatorFullName': 'Ersin Gündoğan', 'investigatorAffiliation': 'Inonu University'}}}}