Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2026-02-22 @ 4:13 AM
Study NCT ID:
NCT05647668
Status:
COMPLETED
Last Update Posted:
2022-12-13
First Post:
2022-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Total vs Partial Fundoplication in Patients With Atypical Symptoms of Gastroesophageal Reflux Disease
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-10', 'studyFirstSubmitDate': '2022-12-03', 'studyFirstSubmitQcDate': '2022-12-03', 'lastUpdatePostDateStruct': {'date': '2022-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom scores of throat clearing, globus sensation, cough, throat pain, vocal changes.', 'timeFrame': '24 month'}], 'secondaryOutcomes': [{'measure': 'Reflux symptom index (RSI) score', 'timeFrame': '24 months', 'description': 'The reflux symptom index (RSI) questionnaire is a nine-item, 45-point survey used in the evaluation of symptoms of laryngopharyngeal reflux. A RSI score higher than 13 is considered abnormal and indicates the presence of laryngopharyngeal reflux.'}, {'measure': 'laryngopharyngeal reflux-health-related quality of life (LPR-HRQL) questionnaire score', 'timeFrame': '24 months', 'description': 'The LPR-HRQL questionnaire is a 43-item survey, designed to assess the effects of extraesophageal reflux symptoms on social and occupational functioning, vitality, well-being and perceived health.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gastroesophageal Reflux Disease']}, 'descriptionModule': {'briefSummary': 'One hundred and twenty patients with documented extraesophageal symptoms of gastroesophageal reflux disease were randomized to either undergo floppy Nissen (n= 60) or Toupet fundoplication (n= 60). Symptom scores of extraesophageal symotoms and quality of life were prospectively evaluated. Analysis of the treatment results showed a significant improvement of symptoms in both patient groups.Quality of life improved substantially at short- and long-term follow up in both groups and there were no statistical differences between the groups in this parameter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* extraesophageal symptoms of gastroesophageal reflux disease\n* undergoing surgery for gastroesophageal reflux disease\n* at least 18 years old\n\nExclusion Criteria:\n\n* patients under the age of 18 years\n* previous anti-reflux surgery, other surgical procedures in the vicinity of the gastroesophageal junction\n* major psychiatric illness\n* unstable chronic illnesses (such as diabetes)\n* inability of the patient to complete the survey.'}, 'identificationModule': {'nctId': 'NCT05647668', 'briefTitle': 'Laparoscopic Total vs Partial Fundoplication in Patients With Atypical Symptoms of Gastroesophageal Reflux Disease', 'organization': {'class': 'OTHER', 'fullName': 'Danylo Halytsky Lviv National Medical University'}, 'officialTitle': 'A Prospective Randomized Trial on Laparoscopic Total vs Partial Fundoplication in Patients With Atypical Symptoms of Gastroesophageal Reflux Disease', 'orgStudyIdInfo': {'id': '2708A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'laparoscopic Nissen fundoplication', 'description': 'Creation of a 360° fundoplication wrap over a 30-Fr intra-esophageal bougie.', 'interventionNames': ['Procedure: Laparoscopic fundoplication']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'laparoscopic Toupet fundoplication', 'description': 'Creation of a 270° fundoplication wrap over a 30-Fr intra-esophageal bougie.', 'interventionNames': ['Procedure: Laparoscopic fundoplication']}], 'interventions': [{'name': 'Laparoscopic fundoplication', 'type': 'PROCEDURE', 'description': 'Creation of either a 360° (in Nissen group) or a 270° (in Toupet group) fundoplication wrap over a 30-Fr intra-esophageal bougie.', 'armGroupLabels': ['laparoscopic Nissen fundoplication', 'laparoscopic Toupet fundoplication']}]}, 'contactsLocationsModule': {'locations': [{'zip': '79010', 'city': 'Lviv', 'country': 'Ukraine', 'facility': 'Danylo Halytsky Lviv National Medical University', 'geoPoint': {'lat': 49.83826, 'lon': 24.02324}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Will be decided after publication of the article'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mykola Paranyak', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, assistant professor at the Department of General Surgery', 'investigatorFullName': 'Mykola Paranyak', 'investigatorAffiliation': 'Danylo Halytsky Lviv National Medical University'}}}}