Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-06-02 @ 5:18 AM
Study NCT ID:
NCT04591860
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2020-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias: Absorbable Mesh vs. Pledgeted Sutures vs. Sutures Only
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006551', 'term': 'Hernia, Hiatal'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010535', 'term': 'Laparoscopy'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'The primary objective of the present trial is to compare the hiatal hernia recurrence rate between three different methods of cruroplasty in large hiatal hernias: hiatal closure with sutures versus pledgeted sutures versus absorbable mesh (Phasix™ST mesh).\n\nThe study includes patients who are scheduled to undergo laparoscopic or robot-assisted surgery for a large symptomatic hiatal hernia. A large hiatal hernia is defined as \\> 5cm in manometry or gastroscopy or at least 1/3 of the stomach lying intrathoracically. The primary study endpoint is defined as the hernia recurrence rate, objectively assessed by gastroscopy. After inclusion in the study, patients will be followed up 6 months, 1 year, 3 years and 5 years after the operation using standardized questionnaires and gastroscopy.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 165}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-01', 'studyFirstSubmitDate': '2020-09-17', 'studyFirstSubmitQcDate': '2020-10-12', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hiatal hernia recurrence rate', 'timeFrame': '6 months, 1 year, 3 years and 5 years after surgery', 'description': 'Hiatal hernia recurrence rate documented by gastroscopy'}], 'secondaryOutcomes': [{'measure': 'Quality of Life evaluated by questionnaire', 'timeFrame': 'Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery', 'description': 'Quality of Life measured by Gastrointestinal Quality of Life Index (GIQLI)'}, {'measure': 'Symptoms related to Gastroesophageal Reflux Disease (GERD)', 'timeFrame': 'Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery', 'description': 'Typical and atypical GERD symptoms assessed by the Symptom Check List (SCL) in units of a scale.'}, {'measure': 'Primary extraesophageal GERD symptoms related to Gastroesophageal Reflux Disease (GERD)', 'timeFrame': 'Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery', 'description': 'Primary atypical GERD symptoms assessed by the Reflux Symptom Index (RSI - Score) in units of a scale'}, {'measure': 'Postoperative complications', 'timeFrame': '6 months, 1 year, 3 years and 5 years after surgery', 'description': 'Short - term and long - term complications after treatment'}, {'measure': 'Length of hospital stay', 'timeFrame': 'up to 90 days', 'description': 'Length of hospital stay and mortality rates'}, {'measure': 'Predictive parameters for treatment response or failure I', 'timeFrame': 'Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery', 'description': 'Weight (in kilograms)'}, {'measure': 'Predictive parameters for treatment response or failure II', 'timeFrame': 'Prior to surgery; 6 months, 1 year, 3 years and 5 years after surgery', 'description': 'Height (in meters)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hiatal hernia', 'pledgets', 'mesh', 'hernia recurrence'], 'conditions': ['Hiatal Hernia']}, 'referencesModule': {'references': [{'pmid': '33567462', 'type': 'DERIVED', 'citation': 'Koch O, von Rahden BHA, Wykypiel H, Schoppmann SF, Fugger R, Rosanelli G, Emmanuel K, Weitzendorfer M. [Planning and Design of a Prospective Randomised Multi-Centre Trial on the Repair of Large Hiatal Hernias with Sutures vs. Pledgeted Sutures vs. Absorbable Mesh]. Zentralbl Chir. 2021 Apr;146(2):204-209. doi: 10.1055/a-1369-9694. Epub 2021 Feb 10. German.'}]}, 'descriptionModule': {'briefSummary': 'A prospective randomised multi - center trial on the repair of large hiatal hernias with sutures versus pledgeted sutures versus absorbable mesh\n\nThe primary objective of the present trial is to compare the hiatal hernia recurrence rate between three different methods of cruroplasty in large hiatal hernias: hiatal closure with sutures versus pledgeted sutures versus absorbable mesh (Phasix™ST mesh).\n\nThe duration of the study is not limited and depends on the number of cases planned. After enrollment in the study, patients will be followed - up with standardized questionnaires and gastroscopy at 6 months, 1 year, 3 years and 5 years after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a large hiatal hernia - admitted for surgery (laparoscopic / robot-assisted)\n* Written informed consent\n* ≥ 18 years of age\n* Hiatal hernia documented by barium x-ray and/or gastroscopy and/or manometry by one or more of the following criteria:\n\n * \\> 5cm hiatal hernia\n * 1/3 of the stomach in the thorax\n\nExclusion Criteria:\n\n* Lack of patient consent for study participation\n* Lack of consent to study due to linguistic or mental incomprehension\n* Patients in poor general condition (lack of anesthesia ability)\n* Pregnancy\n* Prior surgery on the stomach or gastroesophageal junction\n* Simultaneous surgery because of another illness'}, 'identificationModule': {'nctId': 'NCT04591860', 'briefTitle': 'A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias: Absorbable Mesh vs. Pledgeted Sutures vs. Sutures Only', 'organization': {'class': 'OTHER', 'fullName': 'Paracelsus Medical University'}, 'officialTitle': 'A Prospective Randomised Multi - Center Trial on the Repair of Large Hiatal Hernias With Sutures Versus Pledgeted Sutures Versus Absorbable Mesh', 'orgStudyIdInfo': {'id': 'Phasix™ST - Austria'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sutures only', 'description': 'Patients with a large hiatal hernia undergo the cruroplasty with sutures only.\n\nA large hiatal hernia is defined as \\> 5cm in manometry or gastroscopy or at least 1/3 of the stomach lying intrathoracically.', 'interventionNames': ['Device: Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Absorbable Mesh', 'description': 'Patients with a large hiatal hernia undergo the cruroplasty with mesh implantation.\n\nA large hiatal hernia is defined as \\> 5cm in manometry or gastroscopy or at least 1/3 of the stomach lying intrathoracically.', 'interventionNames': ['Device: Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pledgeted sutures', 'description': 'Patients with a large hiatal hernia undergo the cruroplasty with pledgeted sutures.\n\nA large hiatal hernia is defined as \\> 5cm in manometry or gastroscopy or at least 1/3 of the stomach lying intrathoracically.', 'interventionNames': ['Device: Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet']}], 'interventions': [{'name': 'Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet', 'type': 'DEVICE', 'description': 'Patients are scheduled to undergo laparoscopic or robot-assisted surgery for a large symptomatic hiatal hernia.The hiatal closure will be done with sutures, pledgeted sutures or absorbable mesh (Phasix™ST mesh). After cruroplasty a fundoplication according to Toupet will be done additionally.', 'armGroupLabels': ['Absorbable Mesh', 'Pledgeted sutures', 'Sutures only']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Michael Weitzendorfer, MD, PhD', 'role': 'CONTACT', 'email': 'm.weitzendorfer@salk.at', 'phone': '+435725551078'}, {'name': 'Oliver O Koch, MD, FEBS', 'role': 'CONTACT', 'email': 'o.koch@salk.at', 'phone': '+435725551091'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paracelsus Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical University Innsbruck', 'class': 'OTHER'}, {'name': 'Medical University of Vienna', 'class': 'OTHER'}, {'name': 'Krankenhaus Barmherzige Schwestern Linz', 'class': 'OTHER'}, {'name': 'Elisabethinen Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Michael Weitzendorfer, PhD', 'investigatorFullName': 'Michael Weitzendorfer, MD', 'investigatorAffiliation': 'Paracelsus Medical University'}}}}