Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-01-08 @ 11:56 PM
Study NCT ID:
NCT06725433
Status:
RECRUITING
Last Update Posted:
2025-02-19
First Post:
2024-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nissen Versus Dor Hiatal Hernia Repair
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018662', 'term': 'Fundoplication'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective open label randomized trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2030-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-17', 'studyFirstSubmitDate': '2024-11-26', 'studyFirstSubmitQcDate': '2024-12-04', 'lastUpdatePostDateStruct': {'date': '2025-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anatomical recurrence of hiatal hernia', 'timeFrame': '12 months after the surgery', 'description': 'Computed tomography based recurrence after Nissen versus Dor fundoplication'}, {'measure': 'Symptomatic recurrence of hiatal hernia', 'timeFrame': '12 months after the surgery', 'description': 'Anatomical recurrence with questionnaire based gastroesophageal reflux disease (GERD) or dysphagia symptoms, or need for reoperation for recurrence'}], 'secondaryOutcomes': [{'measure': 'Symptomatic versus asymptomatic recurrence rates', 'timeFrame': '12 months', 'description': 'Symptomatic versus asymptomatic recurrence rates at 12 months'}, {'measure': 'Reoperation rates', 'timeFrame': '20 years', 'description': 'Reoperation rates at 3-, 5-, 10- and 20-years following the surgery'}, {'measure': 'Managing GERD symptoms with Nissen vs Dor fundoplication', 'timeFrame': '12 months', 'description': 'The efficacy of Nissen vs Dor fundoplication techniques in improving the Gastroesophageal Reflux Disease-Health Related Quality of Life instrument (GERD-HRQL) scores at 12 months. Minimum score 0 = no symptoms, maximum score 75 = worst symptoms.'}, {'measure': 'Dysphagia symptoms after Nissen vs Dor fundoplication', 'timeFrame': '12 months', 'description': 'The effect of different fundoplication techniques on dysphagia symptoms assessed by Eating Assessment Tool (EAT-10 ) at 12 months. Score range from 0 to 40 with higher scores indicating more severe dysphagia.'}, {'measure': 'Hiatal hernia size and recurrence rates', 'timeFrame': '12 months', 'description': 'The association between hiatal hernia size and recurrence rates. During surgery, the left-to-right and posterior-to-anterior dimensions of the hiatal opening, as well as whether more than 30% of stomach is herniated , will be recorded. These measurements will then be compared to postoperative recurrence rates."'}, {'measure': 'Proton pump inhibitor usage', 'timeFrame': '20 years', 'description': 'Proton pump inhibitor usage will be assessed at 1- 3-, 5-, 10- and 20-years after surgery'}, {'measure': 'The impact of Body Mass Index on recurrence and reoperation rates', 'timeFrame': '20 years', 'description': 'The impact of initial Body Mass Index (BMI, kg/m\\^2) on the recurrence rates (12 months) and reoperation rates (1-, 3-, 5-, 10- and 20-years)'}, {'measure': 'The impact of age on recurrence and reoperation rates', 'timeFrame': '20 years', 'description': 'The impact of subject age (years) on the recurrence rates (12 months) and reoperation rates (1-, 3-, 5-, 10- and 20-years)'}, {'measure': 'The impact of albumin level on recurrence and reoperation rates', 'timeFrame': '20 years', 'description': 'The impact of albumin level (g/l) on the recurrence rates (12 months) and reoperation rates (1-, 3-, 5-, 10- and 20-years)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hiatal Hernia', 'Paraesophageal Hernia', 'Recurrence']}, 'descriptionModule': {'briefSummary': 'Hiatal hernia can present with a wide range of symptoms. An usual surgical repair technique usually includes Nissen fundoplication, while other procedures are less frequently employed. However, recurrence and reoperation rates remain high. This randomized controlled trial aims to compare the efficacy of Nissen and Dor fundoplication in preventing hiatal hernia recurrence and reducing the risk of reoperation\n\nParticipants undergoing minimally invasive hiatal hernia repair will be randomly assigned to either Nissen or Dor fundoplication. Postoperatively at 12 months, anatomical recurrence rates based on computed tomography scans and symptomatic recurrence rates, anti-reflux medication use, GERD-related quality of life, and dysphagia symptoms will be assessed. A subsequent long-term follow-up study will conducted afterwards utilizing national registry data to evaluate reoperation rates and anti-reflux medication use'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age\n* Type II-IV hiatal hernia, confirmed by radiology or endoscopy\n* Scheduled for mini-invasive hiatal hernia repair\n* Emergency mini-invasive surgery for hiatal hernia\n* The informed consent is acquired\n\nExclusion Criteria:\n\n* Recurrent hiatal hernia\n* Need for esophageal lengthening procedure (Collis)\n* Gangrene or need for any resection during (emergency) surgery\n* Need for laparotomy or thoracotomy/thoracoscopy\n* No written consent'}, 'identificationModule': {'nctId': 'NCT06725433', 'acronym': 'NiDor', 'briefTitle': 'Nissen Versus Dor Hiatal Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Kuopio University Hospital'}, 'officialTitle': 'NiDor-study: a Randomized Controlled Trial Comparing Nissen and Dor Fundoplication in Hiatal Hernia Repair', 'orgStudyIdInfo': {'id': 'KUH5204535'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nissen fundoplication', 'description': 'Hiatal hernia repair and Nissen (posterior 360-degree) fundoplication', 'interventionNames': ['Procedure: Nissen fundoplication']}, {'type': 'EXPERIMENTAL', 'label': 'Dor fundoplication', 'description': 'Hiatal hernia repair and Dor (anterior 180-degree) fundoplication', 'interventionNames': ['Procedure: Dor fundoplication']}], 'interventions': [{'name': 'Nissen fundoplication', 'type': 'PROCEDURE', 'description': 'Hiatal hernia repair and Nissen fundoplication', 'armGroupLabels': ['Nissen fundoplication']}, {'name': 'Dor fundoplication', 'type': 'PROCEDURE', 'description': 'Hiatal hernia repair and Dor fundoplication', 'armGroupLabels': ['Dor fundoplication']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70200', 'city': 'Kuopio', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Ville A. Palomäki, MD, PhD', 'role': 'CONTACT', 'email': 'Ville.Palomaki@pshyvinvoitialue.fi'}], 'facility': 'Kuopio University Hospital', 'geoPoint': {'lat': 62.89238, 'lon': 27.67703}}], 'centralContacts': [{'name': 'Ville Palomäki, MD, PhD', 'role': 'CONTACT', 'email': 'Ville.Palomaki@pshyvinvointialue.fi', 'phone': '+35817 173 311'}], 'overallOfficials': [{'name': 'Ville Palomäki, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kuopio University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kuopio University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}