Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2026-01-05 @ 6:22 PM
Study NCT ID:
NCT03130166
Status:
COMPLETED
Last Update Posted:
2021-01-05
First Post:
2017-04-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
INtracorporeal Versus EXtracorporeal Anastomosis in Robotic Right Colectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], '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'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-03', 'studyFirstSubmitDate': '2017-04-23', 'studyFirstSubmitQcDate': '2017-04-25', 'lastUpdatePostDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative recovery', 'timeFrame': '1 month', 'description': 'Questionnaire of Recovery 15 (QoR-15)'}], 'secondaryOutcomes': [{'measure': 'Time fo first flatus', 'timeFrame': '1 month'}, {'measure': 'Time to first bowel movement', 'timeFrame': '1 month'}, {'measure': 'Length of hospital stay', 'timeFrame': '1 month'}, {'measure': 'Morbidity', 'timeFrame': '1 month'}, {'measure': 'Mortality', 'timeFrame': '1 month'}, {'measure': 'Postoperative pain', 'timeFrame': '1 month'}, {'measure': 'Heart Rate Variability', 'timeFrame': '2 days', 'description': 'Continuously ECG-monitoring intraoperatively and postoperatively'}, {'measure': '"Timed up and go"-test', 'timeFrame': '2 days'}, {'measure': 'Ortostatic hypotension test', 'timeFrame': '2 days'}, {'measure': 'Spirometry and PEF - test', 'timeFrame': '2 days', 'description': 'Postoperative pulmonary function'}, {'measure': 'Postoperative opioid usage', 'timeFrame': '1 month'}, {'measure': 'Whole blood gene expression profiling', 'timeFrame': '1 month', 'description': 'Measuring changes in expression of ROS and immulogical genes due to surgery.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative pain', 'Postoperative recovery', 'Intracorporeal anastomosis', 'Robotic right colectomy'], 'conditions': ['Colonic Cancer']}, 'referencesModule': {'references': [{'pmid': '36171282', 'type': 'DERIVED', 'citation': 'Dohrn N, Oppermann C, Yikilmaz H, Laursen M, Khesrawi F, Clausen FB, Jakobsen HL, Brisling S, Lykke J, Eriksen JR, Klein MF, Gogenur I. The effect of intracorporeal versus extracorporeal anastomosis in robotic right colectomy on perianastomotic perfusion: a substudy to a multicenter RCT. Langenbecks Arch Surg. 2022 Dec;407(8):3577-3586. doi: 10.1007/s00423-022-02693-4. Epub 2022 Sep 28.'}, {'pmid': '35129520', 'type': 'DERIVED', 'citation': 'Dohrn N, Yikilmaz H, Laursen M, Khesrawi F, Clausen FB, Sorensen F, Jakobsen HL, Brisling S, Lykke J, Eriksen JR, Klein MF, Gogenur I. Intracorporeal Versus Extracorporeal Anastomosis in Robotic Right Colectomy: A Multicenter, Triple-blind, Randomized Clinical Trial. Ann Surg. 2022 Nov 1;276(5):e294-e301. doi: 10.1097/SLA.0000000000005254. Epub 2021 Oct 13.'}, {'pmid': '33913415', 'type': 'DERIVED', 'citation': 'Dohrn N, Klein MF, Gogenur I. Intracorporeal versus extracorporeal anastomosis in right colectomy - a protocol for a randomised trial. Dan Med J. 2021 Apr 20;68(5):A09200710.'}]}, 'descriptionModule': {'briefSummary': 'Right-sided colonic cancer is treated with right-sided colectomy, predominantly performed as minimally invasive surgery with extracorporeal anastomosis (ECA). In recent years a new technique with intracorporeal anastomosis (ICA) has emerged and it is thought that ICA is less invasive and thereby has the potential to improve the postoperative course of right colonic cancer patients.\n\nThe objective of this study is to compare robotic right colectomy with either ICA or ECA in a randomized controlled setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll patients scheduled for robotic right colectomy due to colonic cancer are eligible for inclusion.'}, 'identificationModule': {'nctId': 'NCT03130166', 'acronym': 'INEXA', 'briefTitle': 'INtracorporeal Versus EXtracorporeal Anastomosis in Robotic Right Colectomy', 'organization': {'class': 'OTHER', 'fullName': 'Herlev and Gentofte Hospital'}, 'officialTitle': 'Intracorporeal Versus Extracorporeal Anastomosis in Robotic Right Colectomy - a Double-blinded Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'RCT0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intracorporeal anastomosis', 'description': 'Patients undergo robotic right colectomy with intracorporeal anastomosis.', 'interventionNames': ['Procedure: Intracorporeal anastomosis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Extracorporeal anastomosis', 'description': 'Patients undergo robotic right colectomy with extracorporeal anastomosis.', 'interventionNames': ['Procedure: Extracorporeal anastomosis']}], 'interventions': [{'name': 'Intracorporeal anastomosis', 'type': 'PROCEDURE', 'description': 'Use of intracorporeal anastomosis technique', 'armGroupLabels': ['Intracorporeal anastomosis']}, {'name': 'Extracorporeal anastomosis', 'type': 'PROCEDURE', 'description': 'Use of the conventional extracorporeal anastomosis technique', 'armGroupLabels': ['Extracorporeal anastomosis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Herlev', 'state': 'Copenhagen', 'country': 'Denmark', 'facility': 'Herlev Hospital', 'geoPoint': {'lat': 55.72366, 'lon': 12.43998}}, {'city': 'Roskilde', 'country': 'Denmark', 'facility': 'Sealand University Hospital', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Herlev and Gentofte Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD.', 'investigatorFullName': 'Niclas Dohrn', 'investigatorAffiliation': 'Herlev and Gentofte Hospital'}}}}