Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2026-01-01 @ 3:07 PM
Study NCT ID:
NCT05069493
Status:
COMPLETED
Last Update Posted:
2022-10-18
First Post:
2021-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Follow-up After Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}, {'id': 'D006551', 'term': 'Hernia, Hiatal'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'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': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, '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': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-16', 'studyFirstSubmitDate': '2021-09-26', 'studyFirstSubmitQcDate': '2021-09-26', 'lastUpdatePostDateStruct': {'date': '2022-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrent hiatal hernia', 'timeFrame': '10 years', 'description': 'The incidence of radiologically verified recurrent hiatal hernia'}], 'secondaryOutcomes': [{'measure': 'Dysphagia', 'timeFrame': '10 years', 'description': 'Dysphagia for liquids and solids were recorded within a four-graded scale stating the frequency of dysphagia episodes with an arbitrary (empirical) cut off for clinical significance. The same dysphagia scoring was also used in a previous rct, from the same institution, comparing different types of antireflux procedures in open surgery.'}, {'measure': 'Gastrointestinal symptom rating scale (GSRS)', 'timeFrame': '10 years', 'description': 'A validated questionnaire containing five dimensions of abdominal symptoms (gastroesophageal reflux, abdominal pain, indigestion, obstipation and diarrhea'}, {'measure': 'Quality of Life, physical and mental score: SF-36', 'timeFrame': '10 years', 'description': 'The Swedish version of the validated global Short Form -36 (SF-36) questionnaire was used and data are presented as physical and mental summary component scores (PCS and MCS, respectively)'}, {'measure': 'Proton pump inhibitor (PPI)', 'timeFrame': '10 years', 'description': 'Number of patients who report daily intake of PPI at the time of the follow up Use of PPI use of PPI'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['GERD', 'Hiatal Hernia', 'Dysphagia, Esophageal', 'Quality of Life']}, 'referencesModule': {'references': [{'pmid': '37819652', 'type': 'DERIVED', 'citation': 'Analatos A, Hakanson BS, Ansorge C, Lindblad M, Lundell L, Thorell A. Hiatal Hernia Repair With Tension-Free Mesh or Crural Sutures Alone in Antireflux Surgery: A 13-Year Follow-Up of a Randomized Clinical Trial. JAMA Surg. 2024 Jan 1;159(1):11-18. doi: 10.1001/jamasurg.2023.4976.'}]}, 'descriptionModule': {'briefSummary': '10 years of follow-up after surgery for hiatal hernia by tension-free mesh closure or simple suturing.', 'detailedDescription': 'One-hundred and fifty-nine patients undergoing Nissen fundoplication for symptomatic gastro-oesophageal reflux disease (GORD), who had a concomitant hiatal hernia of \\> 2 cm axial length, were previously randomized to closure of the diaphragmatic hiatus with either crural sutures alone or tension-free closure with a non-absorbable mesh. Primary outcome variable was the incidence of radiologically verified recurrent hiatal hernia 3 years after the surgery and secondary outcomes were dysphagia score, reflux control and quality of life. The study showed no differences between the groups regarding hiatal hernia recurrence but higher dysphagia scores for solid food at 3 years in mesh group.\n\nThis study is a long-term follow-up (\\>10 years) after surgery for hiatal hernia by tension-free mesh closure or simple suturing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who were included in the previous study (hiatal hernia repair by tension-free mesh closure or simple suturing) and are available for inclusion at the long-term follow-up.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Patients available at the time of follow-up\n\nExclusion Criteria:\n\n* Deceased\n* Declined participation'}, 'identificationModule': {'nctId': 'NCT05069493', 'briefTitle': 'Long-term Follow-up After Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing of the Diaphragmatic Hiatus. Long-term (>10 Years) Follow-up of a Randomized, Double-blind Clinical Trial', 'orgStudyIdInfo': {'id': 'PATCH2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tension-free', 'description': 'Hiatal hernia repair by tension-free mesh closure', 'interventionNames': ['Procedure: mesh']}, {'label': 'Suturing', 'description': 'Hiatal hernia repair by simple suturing of the diaphragmatic', 'interventionNames': ['Procedure: simple suturing']}], 'interventions': [{'name': 'simple suturing', 'type': 'PROCEDURE', 'description': 'Hiatal hernia repair by simple suturing of the diaphragmatic', 'armGroupLabels': ['Suturing']}, {'name': 'mesh', 'type': 'PROCEDURE', 'description': 'Hiatal hernia repair by tension-free mesh closure', 'armGroupLabels': ['Tension-free']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Ersta Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ersta Hospital, Sweden', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Lars Lundell', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}