Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2026-03-01 @ 9:54 PM
Study NCT ID:
NCT03025932
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-13
First Post:
2017-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009074', 'term': 'Melanocyte-Stimulating Hormones'}], 'ancestors': [{'id': 'D053486', 'term': 'Melanocortins'}, {'id': 'D011333', 'term': 'Pro-Opiomelanocortin'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010908', 'term': 'Pituitary Hormones, Anterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2016-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2017-01-09', 'studyFirstSubmitQcDate': '2017-01-17', 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Radiological recurrence rate of hiatal hernia determined by computer tomography (CT) scan', 'timeFrame': 'minimum 1 year after surgery', 'description': 'To evaluate the radiological recurrence rate of hiatal hernia at least one year after surgery by performing a computer tomography'}], 'secondaryOutcomes': [{'measure': 'Quality of life by GIQLI', 'timeFrame': 'minimum 1 year after surgery', 'description': 'Estimate the quality of life using a standardized questionnaire (Gastrointestinal Qualitiy of Life Index = GIQLI) at least one year after surgery'}, {'measure': 'Clinical outcome', 'timeFrame': 'minimum 1 year after surgery', 'description': 'Evaluate the clinical outcome at least one year after surgery by examining the patient and asking targeted questions on the symptoms regarding the former hiatal hernia (using visual analogue scale questions on dysphagia, meteorism, bloating, reflux and retrosternal pain). Furthermore the patients are asked about their general satisfaction regarding the performed surgical intervention.'}, {'measure': 'Peri- and postoperative morbidity / mortality', 'timeFrame': 'minimum 1 year after surgery', 'description': 'Evaluate the peri- and postoperative morbidity and mortality from the patient records and a clinical examination'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hiatal Hernia Large']}, 'referencesModule': {'references': [{'pmid': '39304965', 'type': 'DERIVED', 'citation': 'Susstrunk J, Stimpfle D, Wilhelm A, Ghielmini EM, Potthast S, Zingg U. Clinical and computed tomography outcomes after mesh-enforced hiatoplasty and anterior hemi-fundoplication in large hiatal hernia repair. World J Surg. 2024 Nov;48(11):2669-2677. doi: 10.1002/wjs.12354. Epub 2024 Sep 20.'}]}, 'descriptionModule': {'briefSummary': 'Patients who underwent laparoscopic repair of large hiatal hernias and anterior fundoplication with mesh are examined for their recurrence rate one year after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Inclusion of all patients older than 18 years with initial large hiatal hernia (\\>20% herniated into thoracic cavity) and laparoscopic hiatoplasty with mesh and anterior fundoplication', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age older than 18 years\n* Initially suffering from large hiatal hernia (\\>20% of the stomach in the thoracic cavity)\n* Performance of laparoscopic hiatal hernia repair with mesh and anterior fundoplication\n* Informed Consent as documented by signature (Appendix: Informed Consent Form)\n\nExclusion Criteria:\n\n* Performance of any other anti-reflux surgery such as Toupet- or Nissen-fundoplication\n* Performance of anterior fundoplication without mesh\n* Women who meet the inclusion criteria but are pregnant or breast feeding or have the intention to become pregnant during the course of the study'}, 'identificationModule': {'nctId': 'NCT03025932', 'briefTitle': 'Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia', 'organization': {'class': 'OTHER', 'fullName': 'Spital Limmattal Schlieren'}, 'officialTitle': 'Clinical vs. Radiological Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia With Mesh and Anterior Fundoplication', 'orgStudyIdInfo': {'id': '2016-01510'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient cohort', 'description': 'Patients who underwent laparoscopic hernia repair of giant hiatal hernia with mesh and received anterior fundoplication', 'interventionNames': ['Procedure: repair of giant hiatal hernia with mesh and anterior fundoplication']}], 'interventions': [{'name': 'repair of giant hiatal hernia with mesh and anterior fundoplication', 'type': 'PROCEDURE', 'armGroupLabels': ['Patient cohort']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Urs Zingg', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Principal Investigator'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Prof Urs Zingg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med.', 'investigatorFullName': 'Prof Urs Zingg', 'investigatorAffiliation': 'Spital Limmattal Schlieren'}}}}