Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-02-22 @ 9:42 PM
Study NCT ID:
NCT02871960
Status:
UNKNOWN
Last Update Posted:
2020-01-22
First Post:
2016-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Stress and Colorectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012371', 'term': 'Robotics'}], 'ancestors': [{'id': 'D001331', 'term': 'Automation'}, {'id': 'D013672', 'term': 'Technology'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 170}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-20', 'studyFirstSubmitDate': '2016-07-21', 'studyFirstSubmitQcDate': '2016-08-15', 'lastUpdatePostDateStruct': {'date': '2020-01-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'interleukin 1', 'timeFrame': 'change between time before surgery, 24 hours after surgery, 72 hours after surgery'}, {'measure': 'interleukin 6', 'timeFrame': 'change between time before surgery, 24 hours after surgery, 72 hours after surgery'}, {'measure': 'Tumor necrosis factor alpha', 'timeFrame': 'change between time before surgery, 24 hours after surgery, 72 hours after surgery'}, {'measure': 'C-reactive protein', 'timeFrame': 'change between time before surgery, 24 hours after surgery, 72 hours after surgery'}, {'measure': 'fibrinogen', 'timeFrame': 'change between time before surgery, 24 hours after surgery, 72 hours after surgery'}, {'measure': 'prolactin', 'timeFrame': 'change between time before surgery, 24 hours after surgery, 72 hours after surgery'}, {'measure': 'cortisol', 'timeFrame': 'change between time before surgery, 24 hours after surgery, 72 hours after surgery'}, {'measure': 'insulin', 'timeFrame': 'change between time before surgery, 24 hours after surgery, 72 hours after surgery'}, {'measure': 'glucagon', 'timeFrame': 'change between time before surgery, 24 hours after surgery, 72 hours after surgery'}, {'measure': 'Adrenocorticotropic hormone', 'timeFrame': 'change between time before surgery, 24 hours after surgery, 72 hours after surgery'}, {'measure': 'Growth hormone', 'timeFrame': 'change between time before surgery, 24 hours after surgery, 72 hours after surgery'}, {'measure': 'human leukocyte antigen', 'timeFrame': 'change between time before surgery, 24 hours after surgery, 72 hours after surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Surgical Stress and Immune Function']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate surgical stress and immune function after robotic versus laparoscopic colectomy.', 'detailedDescription': "The short-term advantages of minimally invasive colon resection have been well established in several randomized trials. A major factor in the development of morbidity is the surgical stress response with subsequent increased demand on the patient's reserves and immune competence. Although the advantage in term of stress response of laparoscopic surgery over open surgery has been widely reported, little is known about the role of robotic surgery.\n\nRobotic approaches have seen significant growth in the last 5 years. Taking advantage of three-dimensional visualization, improved articulation, and multiple operating arms provides theoretical advantages in colorectal cancer surgery. In an attempt to evaluate the surgical stress response and immune function after robotic colorectal surgery a comparative study has been designed. Two surgical procedures were evaluated: Robotic colorectal resection (Experimental group) and Laparoscopic colorectal resection (Control group)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible patients will be those with a histologically confirmed malignancy planned for an elective, segmental, curative colectomy\n\nExclusion Criteria:\n\n* Patients with a previous midline laparotomy, emergency surgery, or immune depressant disease or medication will be excluded from this study. Peri-operative or post-operative complications will be considered exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT02871960', 'acronym': 'ESSIMIC', 'briefTitle': 'Surgical Stress and Colorectal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Evaluation of Surgical Stress and Immune Response After Minimally Invasive Colorectal Surgery (ESSIMIC)', 'orgStudyIdInfo': {'id': 'RoboticUnina2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Robotic colectomy', 'description': 'Patients undergoing robotic colectomy for colorectal cancer', 'interventionNames': ['Procedure: Robotic and Laparoscopic Colectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Laparoscopic colectomy', 'description': 'Patients undergoing laparoscopic colectomy for colorectal cancer', 'interventionNames': ['Procedure: Robotic and Laparoscopic Colectomy']}], 'interventions': [{'name': 'Robotic and Laparoscopic Colectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['Laparoscopic colectomy', 'Robotic colectomy']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'Francesco Milone', 'investigatorAffiliation': 'Federico II University'}}}}