Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-01-24 @ 3:37 PM
Study NCT ID:
NCT04268459
Status:
UNKNOWN
Last Update Posted:
2020-02-13
First Post:
2020-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Estimation of Benefit From Regular Versus Leakage-related Exchange of Voice Prosthesis in Patients Post Laryngectomy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011475', 'term': 'Prosthesis Failure'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-03-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-10', 'studyFirstSubmitDate': '2020-02-10', 'studyFirstSubmitQcDate': '2020-02-10', 'lastUpdatePostDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of complications rate.', 'timeFrame': 'Control will be continued for 12 months post laryngectomy.', 'description': 'In both arms of the study we will compare the incidence of following complications: periprosthetic leakage, granulation or atrophy of mucosa around the fistula, dislocation of prosthesis'}], 'secondaryOutcomes': [{'measure': 'Fistula colonization with Candida species.', 'timeFrame': 'Control will be continued for 12 months post laryngectomy.', 'description': 'We will compare microbiological results on subsequent prosthesis exchanges in both arms.'}, {'measure': 'Prosthesis replacement scheme and patient satisfaction.', 'timeFrame': 'Control will be continued for 12 months post laryngectomy.', 'description': 'On each voice prosthesis exchange patients will be asked three questions, assessed with Visual Analog Scale, on their feedback on voice prosthesis use, procedure of prosthesis replacement and voice quality.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['voice prosthesis, laryngectomy, complications'], 'conditions': ['Laryngectomy', 'Voice', 'Prosthesis Failure']}, 'referencesModule': {'references': [{'pmid': '39926276', 'type': 'DERIVED', 'citation': 'Zurek M, Czesak M, Majszyk D, Rzepakowska A. Benefit from regular versus leakage-related exchange of voice prostheses in patients post-laryngectomy considering complication rates and patient satisfaction feedback-a randomized case-controlled trial. Front Oncol. 2025 Jan 24;15:1468955. doi: 10.3389/fonc.2025.1468955. eCollection 2025.'}, {'pmid': '38864228', 'type': 'DERIVED', 'citation': 'Zurek M, Czesak M, Czerwinska ME, Berezovska D, Niemczyk K, Rzepakowska A. A double-blind randomized clinical trial of inflammatory cytokine and pepsin levels in the saliva of patients with voice prostheses. Head Neck. 2024 Sep;46(9):2116-2122. doi: 10.1002/hed.27847. Epub 2024 Jun 12.'}]}, 'descriptionModule': {'briefSummary': 'The tracheoesophageal voice with voice prosthesis is currently the mainstay of voice rehabilitation post laryngectomy. The primary surgical technique of tracheoesophageal fistula formation with insertion of prosthesis and quick and easy process of voice rehabilitation are main encouraging factors. However, the usage of the prosthesis relates to a significant number of complications rated from 10 to 60%. The most common reported complication is transprosthetic leakage that determines the need of device exchange. However in some patients occur more serious complications eg. periprosthetic leakage, granulation or atrophy of mucosa around the fistula, dislocation of prosthesis, that may require anti-inflammatory treatment, temporary nasogastric tube feeding or surgical procedure. The standard protocol is voice prosthesis exchange due to transprosthetic leakage. Optionally the device could be replaced regularly to prevent both transprosthetic leakage and other complication occurrence.\n\nIn the study we plan to compare the benefits from regular (each three month) versus leakage-related exchange of voice prosthesis post laryngectomy including the rate of complications, fistula colonization by Candida species and patients feedback.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients post laryngectomy with primary insertion of voice prosthesis\n\nExclusion Criteria:\n\n* patients post laryngopharyngectomy with digestive tract reconstruction with jejunum of free flap'}, 'identificationModule': {'nctId': 'NCT04268459', 'acronym': 'RvLPE', 'briefTitle': 'Estimation of Benefit From Regular Versus Leakage-related Exchange of Voice Prosthesis in Patients Post Laryngectomy.', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'Estimation of Benefit From Regular Versus Leakage-related Exchange of Voice Prosthesis in Patients Post Laryngectomy Considering Complications Rate, Fistula Colonization by Candida Species and Patients Satisfaction Feedback.', 'orgStudyIdInfo': {'id': '1WF_CT_1_2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Regular exchange', 'description': 'Patients will be appointed each 3 months for regular exchange of voice prosthesis.', 'interventionNames': ['Device: Provox prosthesis exchange']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Leakage exchange', 'description': 'Patients will have voice prosthesis exchange when leakage occurs.', 'interventionNames': ['Device: Provox prosthesis exchange']}], 'interventions': [{'name': 'Provox prosthesis exchange', 'type': 'DEVICE', 'description': 'Each patient post laryngectomy will be randomly assigned to one arm of intervention. The voice prosthesis exchange in all patients will be performed in local anaesthesia. The microbiological samples with cotton swabs will be collected from tracheoesophageal fistula on prosthesis exchange. The clinical evaluation and patients satisfaction from prosthesis usage will be performed on each exchange.', 'armGroupLabels': ['Leakage exchange', 'Regular exchange']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02-097', 'city': 'Warsaw', 'country': 'Poland', 'contacts': [{'name': 'Anna Rzepakowska, PhD', 'role': 'CONTACT', 'email': 'arzepakowska@wum.edu.pl', 'phone': '+48225992521'}, {'name': 'Ewa Osuch-Wójcikiewicz, Professor', 'role': 'CONTACT', 'email': 'eosuch@wum.edu.pl', 'phone': '+48225992521'}], 'facility': 'Department of Otorhinolaryngology, Head andNeck Surgery of Medical University of Warsaw', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Anna Rzepakowska, PhD', 'role': 'CONTACT', 'email': 'arzepakowska@wum.edu.pl', 'phone': '+48225992521'}, {'name': 'Daniel Majszyk, PhD', 'role': 'CONTACT', 'email': 'daniel.majszyk@wum.edu.pl', 'phone': '+48225992521'}], 'overallOfficials': [{'name': 'Anna Rzepakowska, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Medical University of Warsaw'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Date will become available from April 2022 until April 2023.', 'ipdSharing': 'YES', 'accessCriteria': 'on request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Anna Rzepakowska', 'investigatorAffiliation': 'Medical University of Warsaw'}}}}