Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2025-12-26 @ 1:12 AM
Study NCT ID:
NCT04436159
Status:
COMPLETED
Last Update Posted:
2021-09-02
First Post:
2020-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Partial Versus Total Fundoplication in the Surgical Repair of Para-esophageal Hernia.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006551', 'term': 'Hernia, Hiatal'}, {'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], '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': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-28', 'studyFirstSubmitDate': '2020-06-16', 'studyFirstSubmitQcDate': '2020-06-16', 'lastUpdatePostDateStruct': {'date': '2021-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ogilvie dysphagia score', 'timeFrame': '6 months', 'description': "The Ogilvie dysphagia score is a 5-graded scale 0-4 defined as follows: '0', ability to eat ordinary diet; '1', ability to swallow solid food; '2', ability to swallow semisolids; '3', ability to swallow liquids; '4', total inability to swallow ."}], 'secondaryOutcomes': [{'measure': 'intra-and postoperative courses', 'timeFrame': '6 mohths', 'description': 'Peri and postoperative complications.'}, {'measure': 'length of hospital stay', 'timeFrame': '6 months', 'description': 'postoperative length of hospital stay'}, {'measure': 'Watson dysphagia score', 'timeFrame': '6 months', 'description': 'Watson dysphagia score is a validated instrument for benign dysphagia where the patient is asked whether he/she always, sometimes or never has difficulty swallowing nine different groups of liquid and food items.\n\nThis gives a score ranging from zero to 45, where 45 represents the worst possible dysphagia.'}, {'measure': 'Acid reflux control', 'timeFrame': '6 months', 'description': '24-hour pH monitoring'}, {'measure': 'Quality of Life (SF-36)', 'timeFrame': '6 months', 'description': 'The Swedish version of this validated global questionnaire is presented as physical and mental summary component scores (PCS and MCS, respectively). Each subscale scores reaches a value of at the most 100, where higher values reflect better health status.'}, {'measure': 'Radiology', 'timeFrame': '6 months', 'description': 'Radiologically verified recurrent hiatal hernia'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nissen fundoplication', 'Toupet fundoplication', 'crural repair', 'Quality of Life'], 'conditions': ['Paraesophageal Hernia', 'Gastro Esophageal Reflux']}, 'referencesModule': {'references': [{'pmid': '35511051', 'type': 'DERIVED', 'citation': 'Analatos A, Lindblad M, Ansorge C, Lundell L, Thorell A, Hakanson BS. Total versus partial posterior fundoplication in the surgical repair of para-oesophageal hernias: randomized clinical trial. BJS Open. 2022 May 2;6(3):zrac034. doi: 10.1093/bjsopen/zrac034.'}]}, 'descriptionModule': {'briefSummary': 'Short-term follow up after surgery of para-esophageal hernia comparing two different types of fundoplication', 'detailedDescription': 'Laparoscopic para-esophageal hernia (PEH) repair has been established as a safe and effective treatment for symptomatic patients. Today, most surgeons agree that a fundoplication should be included in the hiatal reconstruction in order to reduce the risk of postoperative gastroesophageal reflux and hernia recurrence. However, what type of wrap that should be recommend is yet to be determined.\n\nOne might argue that the overall durability and effectiveness of a partial fundoplication in the control of reflux might be less reliable than a total wrap, but on the contrary, the latter carries the risk of inducing a pseudoachalasia similar situation in PEH patients.\n\nWe therefore designed a double blind randomized clinical trial in which patients with symptomatic paraesophageal hernia to receive either a posterior partial (Toupet) or total (Nissen) fundoplication after hernia reduction and crural repair.\n\nSix months follow up with questionnaires, 24-hour pH monitoring and radiology after surgery of para-esophageal hernia with addition of total fundoplication vs posterial partial fundoplication.\n\nDysphagia Scores; Ogilvie dysphagia score and Watson dysphagia score. Quality of Life; SF-36: physical and mental component scores.\n\nTime points: 1, 3 and 6 months after surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing acute or elective surgery for symptomatic PEH at Ersta Hospital and Karolinska University Hospital\n\nExclusion Criteria:\n\n* age below 18 years\n* axial sliding hiatal hernia only (type I)\n* missing informed consent\n* previous hiatal hernia surgery\n* American Society of Anesthesiologists (ASA) score IV or above\n* achalasia\n* Zollinger-Ellison syndrome\n* malignant tumor\n* inability or unwillingness to complete questionnaires'}, 'identificationModule': {'nctId': 'NCT04436159', 'briefTitle': 'Partial Versus Total Fundoplication in the Surgical Repair of Para-esophageal Hernia.', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'Partial Versus Total Fundoplication in the Surgical Repair of Para-esophageal Hernia. Results of a Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '2008/179-31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nissen fundoplication', 'description': 'Addition of 360 fundoplication after crural closure', 'interventionNames': ['Procedure: Addition of 360 fundoplication after crural closure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Toupet fundoplication', 'description': 'Addition of 180 posterior fundoplication after crural closure', 'interventionNames': ['Procedure: Addition of 180 posterior fundoplication after crural closure']}], 'interventions': [{'name': 'Addition of 360 fundoplication after crural closure', 'type': 'PROCEDURE', 'description': 'A total fundoplication was constructed in which the right and left part of the wrap was brought together in front of, and slightly to the right of the esophagus, and sutured with three interrupted stitches of 2-0 unabsorbable sutures from the GEJ and cranially to attain a length between the top and bottom sutures of at the most 2 cm. At least one wrap suture included the esophageal muscle-wall.', 'armGroupLabels': ['Nissen fundoplication']}, {'name': 'Addition of 180 posterior fundoplication after crural closure', 'type': 'PROCEDURE', 'description': 'The wrap was pulled dorsally around the distal part of the esophagus and GEJ, which was encircled approximately 180-200 degrees. First, the wrap was anchored with Gore-tex sutures, dorsally to the left crus with 3 sutures and then to the right crus with another 3 sutures.\n\nFinally, the wrap was completed with 3-4 sutures, between the edges of the wrap and the right and left side of the esophageal wall, respectively.', 'armGroupLabels': ['Toupet fundoplication']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Ersta Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Lars Lundell, professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinska Institutet'}]}, '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'}}}}