Ignite Creation Date:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2026-01-15 @ 1:11 PM
Study NCT ID:
NCT02080702
Status:
TERMINATED
Last Update Posted:
2018-07-02
First Post:
2014-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An International, Multicentric, Prospective, Observational Study to Evaluate Monosyn® Suture Material for Anastomoses in the Gastrointestinal Tract
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Planned recruitment of 630 patients was not possible to achieve within the given time frame', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-29', 'studyFirstSubmitDate': '2014-03-05', 'studyFirstSubmitQcDate': '2014-03-05', 'lastUpdatePostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of anastomosis leakage rate', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 7 days', 'description': 'Anastomotic leak is defined as radiographic demonstration of a fistula or non-absorbable material drainage from a wound after oral administration, or visible disruption of the suture line during re-exploration.'}], 'secondaryOutcomes': [{'measure': 'Postoperative complication rate', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 7 days', 'description': 'As postoperative complications the following parameter will be documented: peritonitis, wound infection, bleeding, abscess, fistula, perforation, obstipation and stenosis. Wound infections, peritonitis and abscess are defined according to the Centres for Disease Control and Prevention (CDC, 17).'}, {'measure': 'Reoperation rate', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 7 days'}, {'measure': 'Length of hospital stay', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 10 days', 'description': 'Duration from day of operation until the day of discharge from the hospital.'}, {'measure': 'Stay in the intensive care unit', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 7 days', 'description': 'Duration from the first day in the ICU until the last day in the ICU. In the case of readmission to the ICU the sum of all days within the ICU.'}, {'measure': 'Duration to perform the anastomosis', 'timeFrame': 'intraoperatively', 'description': 'The time recorded for the construction of the anastomosis begins with the placement of the first stitch and ends with cutting the excess material from the last stitch.'}, {'measure': 'Cost', 'timeFrame': 'duration of the intervention (approximately 18 months)', 'description': 'Calculation of the cost of material is based on the actual hospital costs for the suture material and the number of used threads by the surgeon.\n\nFor the calculation of the operation costs, the time to perform the anastomosis will be multiplied with the cost of one operation minute (50-100 €).'}, {'measure': 'Handling of the device', 'timeFrame': 'End of the Study (approximately 18 months)', 'description': 'Intra-operative handling of the suture material will be reported on a separate document one time per participating surgeon at the end of the study. The following criteria will be assessed:\n\nknot security, knot pull tensile strength, knot run-down, tissue drag, elasticity and feeling of the suture material. For the rating a 5-point scale is used'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GIT, Monosyn, anastomoses leakage'], 'conditions': ['C.Surgical Procedure; Digestive System', 'Symptomatic Disorders of the Gastrointestinal Tract', 'Gastric Anastomosis (Site)', 'Gastrointestinal Neoplasms']}, 'referencesModule': {'references': [{'pmid': '29946452', 'type': 'RESULT', 'citation': 'Baumann P, Kim J, Ahn SH, Kim HH, Chong HY, Wente MN. Mid-term absorbable monofilament is safe and effective for gastrointestinal anastomosis - PROMEGAT - A single-arm prospective observational study. Ann Med Surg (Lond). 2018 Apr 6;30:1-6. doi: 10.1016/j.amsu.2018.04.003. eCollection 2018 Jun.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this non-interventional study is to evaluate the efficacy of a monofilament, mid-term absorbable suture material (Monosyn®) for anastomosis performed in the gastrointestinal tract using the frequency of anastomosis leakage as a primary parameter.\n\nPostoperative complication rate, length of hospital stay, costs, time to perform the anastomosis and handling will serve as secondary endpoints.\n\nThe question is addressed, whether a monofilament suture material is as effective as a braided suture material for anastomosis construction within the gastrointestinal tract.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adult patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years and older\n* ASA I-III\n* Indication for an elective tumor surgery within the GI tract (stomach, small intestine, large intestine)\n* Written informed consent\n\nExclusion Criteria:\n\n* Emergency surgery\n* Peritonitis\n* Patients undergoing an operation due to a tumour within the pancreas, rectum, esophagus\n* Pregnant women and breast-feeding women\n* Chemotherapy\n* Current immunosuppressive therapy\n* Radiotherapy on the treated region within the last 2 months'}, 'identificationModule': {'nctId': 'NCT02080702', 'acronym': 'PROMEGAT', 'briefTitle': 'An International, Multicentric, Prospective, Observational Study to Evaluate Monosyn® Suture Material for Anastomoses in the Gastrointestinal Tract', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aesculap AG'}, 'officialTitle': 'An International, Multicentric, Prospective, Observational Study to Evaluate Monosyn® Suture Material for Anastomoses in the Gastrointestinal Tract.', 'orgStudyIdInfo': {'id': 'AAG-O-H-1209'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Monosyn', 'description': 'Construction of a gastrointestinal anastomoses', 'interventionNames': ['Device: Monosyn']}], 'interventions': [{'name': 'Monosyn', 'type': 'DEVICE', 'description': 'Monosyn will be used to perform the gastrointestinal anastomoses', 'armGroupLabels': ['Monosyn']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59100', 'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'University Malaya Medical Centre', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'city': 'Manila', 'country': 'Philippines', 'facility': 'Philippine General Hospital', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'zip': '135-72', 'city': 'Gangnam-Gu, Seoul', 'country': 'South Korea', 'facility': 'GangNam Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '463-707', 'city': 'Gyeonggi-do', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '112 Beitou District', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Veterans General Hospital-Taipei', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aesculap AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'B.Braun Surgical SA', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}