Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2025-12-27 @ 3:17 AM
Study NCT ID:
NCT04175756
Status:
COMPLETED
Last Update Posted:
2021-07-15
First Post:
2019-11-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CAIman 5 Articulating Maryland in coloRECTAL Cancer Surgery
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-14', 'studyFirstSubmitDate': '2019-11-19', 'studyFirstSubmitQcDate': '2019-11-21', 'lastUpdatePostDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total operative time', 'timeFrame': 'intraoperatively', 'description': 'Time between first incision and closure of the surgical incision'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': 'up to 4 months postoperative', 'description': 'Number of Complications: Wound infections, Urinary tract infections, Pulmonary infections, Other infections, Wound dehiscence, Anastomotic leak, Anastomotic bleeding, Other bleeding / hemorrhage, Intraabdominal abscess, Fistula, Peritonitis, Sepsis, Hernia, Stenosis Ileus, Ureter injury, Nerve injury, Cardiac complications, Other'}, {'measure': 'Handling characteristics', 'timeFrame': 'intraoperative', 'description': 'Evaluation of performance and handling characteristics using a questionnaire containing 5-level Likert scales (excellent, very good, good, fair, poor)'}, {'measure': 'Estimated intraoperative blood loss', 'timeFrame': 'intraoperative', 'description': 'intraoperative blood loss in ml'}, {'measure': 'Time needed for TME', 'timeFrame': 'Intraoperative', 'description': 'Time between end of left flexure mobilization and stapling'}, {'measure': 'Time needed for PME', 'timeFrame': 'Intraoperative', 'description': 'Time \\[in minutes\\] between end of left flexure mobilization and stapling'}, {'measure': 'Time needed for CME', 'timeFrame': 'Intraoperative', 'description': 'Time \\[in minutes\\] between end of ileocolic vessels clipping and start of right flexure mobilization'}, {'measure': 'Time needed for right / hepatic colic flexure mobilization', 'timeFrame': 'Intraoperative', 'description': 'Time \\[in minutes\\] between end CME and start of resection of the mesentery of the small intestine'}, {'measure': 'Time needed for left / splenic colic flexure mobilization', 'timeFrame': 'Intraoperative', 'description': 'Time \\[in minutes\\] between clipping of inferior mesenteric vessels and start of TME, PME or corresponding)'}, {'measure': 'Stay in intensive care unit postop', 'timeFrame': 'up to discharge (approximately 10 days postoperative)', 'description': 'Number of days postoperative until discharge from intensive care unit'}, {'measure': 'Stay in intermediate care unit stay postop', 'timeFrame': 'up to discharge (approximately 10 days postoperative)', 'description': 'Number of days postoperative until discharge from intermediate care unit stay'}, {'measure': 'First postoperative oral intake', 'timeFrame': 'up to discharge (approximately 10 days postoperative)', 'description': "Number of days until patient's first postoperative oral intake"}, {'measure': 'First postoperative stool', 'timeFrame': 'up to discharge (approximately 10 days postoperative)', 'description': "Number of days until patient's first postoperative stool after oral intake"}, {'measure': 'Quality of excision: M.E.R.C.U.R.Y. criteria', 'timeFrame': 'up to discharge (approximately 10 days postoperative)', 'description': 'quality of mesorectal excision according to criteria established in the "Magnetic Resonance Imaging and Rectal Cancer European Equivalence Study" (M.E.R.C.U.R.Y.)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colorectal cancer', 'laparoscopic surgery', 'Seal & Cut', 'Total Mesorectal Excision (TME)', 'Partial Mesorectal Excision (PME)', 'Complete Mesocolic Excision (CME)'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'This voluntary study is part of a Post-Market-Surveillance plan to proactively collect clinical data for the use of Caiman 5 articulating Maryland in colorectal surgery under daily clinical routine.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient´s written informed consent\n* Planned laparoscopic colorectal cancer surgery using Caiman 5 articulating Maryland (according to the IfU)\n* Age ≥18 years\n\nExclusion Criteria:\n\n* Emergency surgery\n* Pregnancy\n* Participation in another surgical study, which might influence the intraoperative process\n* Conversion to open surgery\n* Conversion to another sealing / cutting instrument (instead of Caiman 5 articulating Maryland)'}, 'identificationModule': {'nctId': 'NCT04175756', 'acronym': 'CAIRECTAL', 'briefTitle': 'CAIman 5 Articulating Maryland in coloRECTAL Cancer Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aesculap AG'}, 'officialTitle': 'CAIman 5 Articulating Maryland in coloRECTAL Cancer Surgery. An Observational, Prospective, Post-marketing Clinical Follow-up Study', 'orgStudyIdInfo': {'id': 'AAG-O-H-1627'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Caiman 5 articulating Maryland', 'type': 'DEVICE', 'description': 'Laparoscopic colorectal surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '45131', 'city': 'Essen', 'country': 'Germany', 'facility': 'Alfried Krupp Krankenhaus Rüttenscheid', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}], 'overallOfficials': [{'name': 'Niedergethmann, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alfried Krupp Krankenhaus, 45131 Essen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aesculap AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}