Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-31 @ 10:50 PM
Study NCT ID:
NCT04335734
Status:
COMPLETED
Last Update Posted:
2020-04-06
First Post:
2020-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Wrap Fixation Technique on the Results of Fundoplication
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'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'}]}, '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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-02', 'studyFirstSubmitDate': '2020-04-02', 'studyFirstSubmitQcDate': '2020-04-02', 'lastUpdatePostDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence rate of hiatal hernia', 'timeFrame': '60 months', 'description': 'Recurrence of hiatal hernia will be assessed by barium contrast swallow study'}, {'measure': 'Slipped wrap', 'timeFrame': '60 months', 'description': 'Slipped wrap will be assessed by barium contrast swallow study'}], 'secondaryOutcomes': [{'measure': 'Quality of life and satisfaction', 'timeFrame': '60 months', 'description': 'Quality of life and satisfaction will be assessed by Gastroesophageal reflux disease - health-related quality of life (GERD-HRQL) score. The scale has 11 items,each item is scored from 0 to 5. A higher score indicating a better quality of life.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastro Oesophageal Reflux Disease, Nissen Fundoplication'], 'conditions': ['Gastro Oesophageal Reflux Disease']}, 'descriptionModule': {'briefSummary': 'Patients who underwent anti-reflux surgery were divided into two groups. In the I group Nissen fundoplication was supplemented with suturing wrap to the crura or the body of stomach using two non-absorbable stitches on each side. Control group included patients who underwent classic Nissen fundoplication without wrap fixation. All patients were assessed before and after surgery using validated symptoms and quality of life (GERD-HRQL) questionnaires, 24-h impedance-pH monitoring and barium-swallow.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 20 - 80 years;\n* Gastroesophageal reflux disease as evidence by gastroscopy and pH-monitoring;\n* HH type I, II\n\nExclusion Criteria:\n\n* Age \\< 20 years and \\> 80 years;\n* Unable to undergo laparoscopic fundoplication due to: severe comorbidities (ASA III and more), previous major surgery with severe adhesions, etc.;\n* HH type III, IV;\n* BMI \\< 16 and \\> 45 kg/m²;\n* Pregnancy (in females);\n* Oesophageal motility disorders;\n* Oesophageal peptic strictures;\n* Oesophageal diverticula, other types (i.e. non-reflux) of chronic esophagitis, connective tissue disorders (e.g. scleroderma);\n* History of oesophageal/gastric/duodenal surgery including vagotomy;\n* Relapsing course of ulcer disease/hyperacid gastritis including complicated by delayed gastric/duodenal emptying'}, 'identificationModule': {'nctId': 'NCT04335734', 'briefTitle': 'Influence of Wrap Fixation Technique on the Results of Fundoplication', 'organization': {'class': 'OTHER', 'fullName': 'Odessa National Medical University'}, 'officialTitle': 'Influence of Wrap Fixation Technique on the Results of Fundoplication', 'orgStudyIdInfo': {'id': 'ONMedU 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Nissen fundoplication with fixation of the wrap', 'description': 'In this arm, which included 87 patients we performed the following manipulations: NF was supplemented with suturing wrap to the diaphragmatic crura (52 patients) on each side using two non-absorbable stitches. In case of weak conditions of crura or short esophagus (35 patients) fundoplication wrap was sutured to the body of stomach using two non-absorbable stitches on each side. .', 'interventionNames': ['Procedure: Nissen Fundoplication with wrap fixation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nissen fundoplication without fixation of the wrap', 'description': 'Arm included 51 patients, who underwent classic Nissen fundoplication without wrap fixation.', 'interventionNames': ['Procedure: Nissen Fundoplication without wrap fixation']}], 'interventions': [{'name': 'Nissen Fundoplication with wrap fixation', 'type': 'PROCEDURE', 'description': 'Firstly, we performed left crural dissection, division of the short gastric vessels, right crural dissection, and esophageal mobilization. Then repair of HH were made by simple cruroraphy if the size of the defect was less then 10 сm² otherwise mesh for reinforcement of cruroraphy was used. Creation of the wrap was made by passing posterior fundus behind the esophagus from left to right, followed by stitching the edges of the stomach with three interrupted sutures. Wrap was fixated to both diaphragmatic crura or to the body of stomach using two non-absorbable stitches on each side.', 'armGroupLabels': ['Nissen fundoplication with fixation of the wrap']}, {'name': 'Nissen Fundoplication without wrap fixation', 'type': 'PROCEDURE', 'description': 'Firstly, we performed left crural dissection, division of the short gastric vessels, right crural dissection, and esophageal mobilization. Then repair of HH were made by simple cruroraphy if the size of the defect was less then 10 сm² otherwise mesh for reinforcement of cruroraphy was used. Creation of the wrap was made by passing posterior fundus behind the esophagus from left to right, followed by stitching the edges of the stomach with three interrupted sutures.', 'armGroupLabels': ['Nissen fundoplication without fixation of the wrap']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grubnik Volodymyr', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, Professor', 'investigatorFullName': 'Grubnik Volodymyr', 'investigatorAffiliation': 'Odessa National Medical University'}}}}