Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-25 @ 7:40 PM
Study NCT ID:
NCT05662735
Status:
UNKNOWN
Last Update Posted:
2022-12-22
First Post:
2022-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laparoscopic Primary Diaphragm Versus Mesh Repair for Hiatus Hernia: a Long-Term Follow-Up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006551', 'term': 'Hernia, Hiatal'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D006548', 'term': 'Hernia, Diaphragmatic'}, {'id': 'D000082122', 'term': 'Internal Hernia'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Patients were blinded for repair with sutures alone or sutures with mesh augmentation'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomised controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-15', 'studyFirstSubmitDate': '2022-12-07', 'studyFirstSubmitQcDate': '2022-12-15', 'lastUpdatePostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of objective recurrence of a hiatal hernia', 'timeFrame': '5-10 years', 'description': 'Objective measurement of the integrity of the hiatal hernia repair by CT-imaging'}], 'secondaryOutcomes': [{'measure': 'Percentage of clinical recurrence of a hiatal hernia', 'timeFrame': '5-10 years', 'description': 'Recurrence of symptoms related to a hiatal hernia measured by a questionnaire'}, {'measure': 'Symptoms of gastroesophageal reflux disease', 'timeFrame': '5-10 years', 'description': 'Percentage of participants that develop postoperative gastroesophageal reflux disease, measured by a questionnaire'}, {'measure': 'Patient satisfaction', 'timeFrame': '5-10 years', 'description': "Overall satisfaction with surgical outcome measured by a questionnaire, on a scale from 0 to 10, where 0 means very unsatisfied with the outcome of the operation and 10 means very satisfied with the outcome of the operation. An additional question will be asked that assesses if the patient would undergo the operation again and can be answered by a simple 'yes' or 'no'."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hernia, Hiatal', 'Laparoscopic', 'Surgery', 'Recurrence', 'Mesh', 'Primary']}, 'descriptionModule': {'briefSummary': 'Assessment of the recurrence of hiatal hernia five to ten years after repair using sutures versus sutures reinforced with non-absorbable mesh.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant of the initial PRIME study\n* Alive\n\nExclusion Criteria:\n\n* No informed consent\n* Additional hiatal hernia repair surgery during the follow-up period\n* Pregnancy\n* Patients that have stated they do not want to be approached for follow-up research'}, 'identificationModule': {'nctId': 'NCT05662735', 'acronym': 'PRIME LTFU', 'briefTitle': 'Laparoscopic Primary Diaphragm Versus Mesh Repair for Hiatus Hernia: a Long-Term Follow-Up', 'organization': {'class': 'OTHER', 'fullName': 'Rijnstate Hospital'}, 'officialTitle': 'Randomized Controlled Trial of Laparoscopic Primary Diaphragm Repair With Sutures Alone Versus Sutures Reinforced With Mesh for Hiatus Hernia: A Long Term Follow-Up', 'orgStudyIdInfo': {'id': 'NL82840.100.22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Non-absorbable sutures', 'description': 'The hiatal hernia was corrected performing laparoscopic surgery. Primary repair of the hernia was done with non-absorbable sutures', 'interventionNames': ['Procedure: Suture repair']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-absorbable sutures and a TiMESH®', 'description': 'The hiatal hernia was corrected performing laparoscopic surgery. Primary repair of the hernia was done with non-absorbable sutures and a TiMESH® to reinforce the repair.', 'interventionNames': ['Device: Mesh repair', 'Procedure: Suture repair']}], 'interventions': [{'name': 'Mesh repair', 'type': 'DEVICE', 'description': 'Augmentation of hiatal hernia repair with TiMESH® reinforcement', 'armGroupLabels': ['Non-absorbable sutures and a TiMESH®']}, {'name': 'Suture repair', 'type': 'PROCEDURE', 'description': 'Primary laparoscopic repair of the hiatal hernia using non-absorbable sutures', 'armGroupLabels': ['Non-absorbable sutures', 'Non-absorbable sutures and a TiMESH®']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Olivier Bouwmeester, MSc', 'role': 'CONTACT', 'email': 'obouwmeester@rijnstate.nl', 'phone': '088 - 005 8888'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rijnstate Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rijnstate Vriendenfonds', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}