Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:15 AM
Study NCT ID:
NCT05233020
Status:
UNKNOWN
Last Update Posted:
2022-02-10
First Post:
2022-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Robotic Versus Hybrid Assisted Ventral Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D006555', 'term': 'Hernia, Ventral'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-09', 'studyFirstSubmitDate': '2022-01-05', 'studyFirstSubmitQcDate': '2022-02-09', 'lastUpdatePostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Robotic-assisted ventral hernia repair vs hybrid. Change in pain', 'timeFrame': '1-year', 'description': 'VAS scale from 0 to 10. Zero in VAS is no pain and number ten is the highest possible pain'}], 'secondaryOutcomes': [{'measure': 'Robotic-assisted ventral hernia repair vs hybrid. Change in the social functioning status.', 'timeFrame': '1-year', 'description': 'SF-36. Scale from 0 to 100. For all scales, higher scores (100) represent better function or outcome'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ventral hernia', 'Laparoscopy', 'Robot-assisted', 'pain'], 'conditions': ['Pain', 'Quality of Life', 'Recurrence']}, 'descriptionModule': {'briefSummary': 'Laparoscopic ventral hernia repair (LVHR) may be associated with chronic pain, seroma formation, bulging and failure to restore abdominal wall function. These outcomes are risk factors for hernia recurrence and poor quality of life (QoL). Our study evaluates whether robotic-assisted ventral hernia repair (rVHR) diminish these complications compared to LVHR with primary closure of the defect (hybrid).', 'detailedDescription': 'Thirty patients undergoing incisional ventral hernia operation with fascial defect size from 3 to 6 cm will be recruited. Fifteen patients undergo rVHR and fifteen undergo hybrid operation.The main outcome measure is postoperative pain, evaluated with visual analogue scale (VAS: 0-10) preoperatively, at 1-week, at 1-month and at 1-year. Hernia recurrence will be evaluated with ultrasound examination at 1-year and QoL using the generic SF-36 short form questionnaire preoperatively, at 1-month and at 1-year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ventral hernia size 3-6 cm\n\nExclusion Criteria:\n\n* previous ventral hernia'}, 'identificationModule': {'nctId': 'NCT05233020', 'acronym': 'ROHYB', 'briefTitle': 'Robotic Versus Hybrid Assisted Ventral Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Kuopio University Hospital'}, 'officialTitle': 'Robotic Assisted vs. Laparoscopic Hybrid IPOM Ventral Hernia Repair: a Prospective Randomized Study Comparing Postoperative Outcomes', 'orgStudyIdInfo': {'id': '5200662'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Robotic', 'description': 'Fifteen patients undergo rVHR operation.', 'interventionNames': ['Device: robotic']}, {'type': 'EXPERIMENTAL', 'label': 'hybrid', 'description': 'Fifteen patients undergo hybrid operation.', 'interventionNames': ['Device: hybrid']}], 'interventions': [{'name': 'robotic', 'type': 'DEVICE', 'description': 'fifteen patients undergo robotic operation', 'armGroupLabels': ['Robotic']}, {'name': 'hybrid', 'type': 'DEVICE', 'description': 'fifteen patients undergo hybrid operation', 'armGroupLabels': ['hybrid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70200', 'city': 'Kuopio', 'state': 'Northern Savonia', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Pirjo Käkelä, PhD', 'role': 'CONTACT', 'email': 'pirjo.kakela@kuh.fi', 'phone': '044 717 4796'}, {'name': 'Kirsi Mustonen, MD', 'role': 'CONTACT', 'email': 'kirsi.m.mustonen@kuh.fi', 'phone': '044 717 5732'}], 'facility': 'Kuopio University Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}], 'centralContacts': [{'name': 'Pirjo Käkelä, PhD', 'role': 'CONTACT', 'email': 'pirjo.kakela@kuh.fi', 'phone': '044 717 4796'}, {'name': 'Kirsi Mustonen, MD', 'role': 'CONTACT', 'email': 'kirsi.m.mustonen@kuh.fi', 'phone': '044 717 5732'}], 'overallOfficials': [{'name': 'Pirjo Käkelä, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'gi -surgeon, clinical teacher'}, {'name': 'Pirjo Käkelä, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'gi-surgeon, clinical teacher'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical teacher, MD, PhD', 'investigatorFullName': 'Kakela Pirjo', 'investigatorAffiliation': 'Kuopio University Hospital'}}}}