Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2025-12-29 @ 8:12 AM
Study NCT ID:
NCT05195957
Status:
COMPLETED
Last Update Posted:
2022-01-19
First Post:
2021-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcomes of Open Versus Robotic-assisted Laparoscopic Posterior Component Separation in Complex Abdominal Wall Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}], 'ancestors': [{'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 169}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-13', 'studyFirstSubmitDate': '2021-12-29', 'studyFirstSubmitQcDate': '2022-01-13', 'lastUpdatePostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of postoperative hospital stay', 'timeFrame': 'immediately after the surgery', 'description': 'Postoperative treatment and follow-up period in hospital'}], 'secondaryOutcomes': [{'measure': 'Complication rates', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Postoperative complications during 30 days after surgery and longer follow-up'}, {'measure': 'Recurrence and reoperation rates', 'timeFrame': 'through study completion, an average of 2 year', 'description': 'Postoperative recurrence of hernia and possible reoperations for recurrence'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Abdominal wall surgery', 'Open surgery', 'Robotic surgery', 'Transversus abdominis release', 'Posterior component separation technique'], 'conditions': ['Abdominal Wall Hernia']}, 'descriptionModule': {'briefSummary': 'This is a retrospective European multicenter study evaluating surgical treatment of patients with a complex ventral incisional hernia using robotic-assisted laparoscopic transversus abdominis release (rTAR) or open transversus abdominis release (oTAR).', 'detailedDescription': 'Consecutive patients who undergo bilateral TAR in the treatment of their ventral incisional hernia in two European hernia centers are included in the study. A retrospective analysis of a prospectively maintained database and electronic patient files will be performed. Primary endpoint of the study was length of postoperative hospital stay. Secondary endpoints are intraoperative complications, in-hospital complications, overall and surgical site related complications during the first 30 postoperative days, overall and surgical site related complications during the reported follow-up period, and hernia recurrence during the reported follow-up period.\n\nData on the following variables wlll be collected.\n\n* Patient characteristics: age, sex, body-mass index (BMI), comorbidities, smoking habits, previous hernia repair and hernia dimensions\n* Intraoperatively: skin-to-skin operative time, wound contamination class (according to the center for disease control and prevention (CDC) classification)15, administration of antibiotics, mesh type used, mesh size, closure of the hernia defect, combined surgical procedures and intraoperative complications.\n* Postoperatively at discharge: length of postoperative hospital stay and in-hospital complications.\n* Postoperatively at 30 days after surgery: overall (according to the Clavien-Dindo classification)16 and surgical site related complications17, readmission rates during the first 30 days after surgery.\n* During follow-up: duration of reported follow-up, reoperation rates and hernia recurrences during the reported follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients undergoing bilateral either open of robotic-assisted transversus abdominis release in the treatment of their ventral incisional hernia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All consecutive patients undergoing bilateral either open of robotic-assisted transversus abdominis release in the treatment of their ventral incisional hernia.\n\nExclusion Criteria:\n\n* unilateral transversus abdominis release\n* patients with a stoma or parastomal hernia'}, 'identificationModule': {'nctId': 'NCT05195957', 'acronym': 'EUROTAR', 'briefTitle': 'Outcomes of Open Versus Robotic-assisted Laparoscopic Posterior Component Separation in Complex Abdominal Wall Repair', 'organization': {'class': 'OTHER', 'fullName': 'University of Oulu'}, 'officialTitle': 'Outcomes of Open Versus Robotic-assisted Laparoscopic Posterior Component Separation in Complex Abdominal Wall Repair A Retrospective Multicenter Case-control Study', 'orgStudyIdInfo': {'id': '12/2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'rTAR', 'description': 'All consecutive patients undergoing bilateral robotic transversus abdominis release operation in the treatment of their ventral incisional hernia, are considered eligible for inclusion.', 'interventionNames': ['Procedure: Robotic tranversus abdominis release operation']}, {'label': 'oTAR', 'description': 'All consecutive patients undergoing bilateral open transversus abdominis release operation in the treatment of their ventral incisional hernia, are considered eligible for inclusion.', 'interventionNames': ['Procedure: Open transversus abdominis release operation']}], 'interventions': [{'name': 'Robotic tranversus abdominis release operation', 'type': 'PROCEDURE', 'description': 'Mini-invasive robotic-assisted TAR using either DaVinci Xi or Si systems and 6 laparoscopic ports.', 'armGroupLabels': ['rTAR']}, {'name': 'Open transversus abdominis release operation', 'type': 'PROCEDURE', 'description': 'Original open TAR using midline incision.', 'armGroupLabels': ['oTAR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'Hospital Maria Middelares', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '90230', 'city': 'Oulu', 'country': 'Finland', 'facility': 'Tero Rautio', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'After results are published without any time limitations', 'ipdSharing': 'YES', 'description': 'All data is available for European Hernia Society researchers', 'accessCriteria': 'When asked'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oulu', 'class': 'OTHER'}, 'collaborators': [{'name': 'Algemeen Ziekenhuis Maria Middelares', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}