Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-02-11 @ 8:47 AM
Study NCT ID:
NCT04319432
Status:
UNKNOWN
Last Update Posted:
2020-03-24
First Post:
2020-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Duration of Voice Rest After Surgery for Benign Vocal Lesions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective Study. In this study, patients will be placed into one of two different groups of voice rest duration. The voice rest durations will last either 3 or 7 days. Voice recording results of the different groups will be examined and analyzed. At the conclusion of this study, we hope to provide some clarity as to the optimal duration of voice rest following phonosurgery.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-23', 'studyFirstSubmitDate': '2020-03-19', 'studyFirstSubmitQcDate': '2020-03-23', 'lastUpdatePostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'better voice quality by GRABS scale', 'timeFrame': '6 months post op', 'description': 'GRABS scale- Grade, Roughness, Breathiness, Asthenia, Strain (GRBAS) each ranked from 0 to 3'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vocal Fold Polyp', 'Vocal Cord Cyst', 'Vocal Nodules in Adults']}, 'descriptionModule': {'briefSummary': 'Aim of Study:\n\nTo determine the optimal duration of voice rest following phonosurgery for patients who undergo phonosurgery due to benign vocal cord lesions IE: vocal fold nodules, cysts, polyps, granulomas, leukoplakia, and subepithelial edema.', 'detailedDescription': 'Optimal Duration of Voice Rest Voice Following Phonosurgery for benign vocal lesions: Prospective Randomized Study\n\nBackground:\n\nPhonosurgery is performed in order to improve voice quality in patients with various vocal fold pathologies including nodules, cysts, polyps, granulomas, leukoplakia, and subepithelial edema. It is customary to order the patients voice rest following vocal fold surgery, however, according to the current literature, it is not well known how long patients should remain in voice rest following phonosurgery (regardless of the type of benign lesion) in order to achieve the best voice quality results. In the literature, there is one preliminary study that shows that when voice quality was assessed at 15 days post-surgery, patients with voice rest of 10 days had better voice outcomes compared to patients with 5 days voice rest(1). A contradicting study, that measured voice outcomes in patients at 1, 3, and 6 months post-operatively, shows that a short voice rest of 3 days lead to better voice results compared to a 7 days voice rest(2).\n\nThe aim of our study is to determine the optimal duration (3 versus 7 days) of voice rest following phonosurgery for patients who undergo phonosurgery due to benign vocal cord lesions in order to achieve better voice quality post-operatively. In this study, patients will be randomly assigned into one of 2 different groups of voice rest durations: either 3 or 7 days following surgery. Patients will undergo pre and post (at 1, 3 and 6 months) operative voice testing. Voice quality testing will include: perceptual voice analysis using the GRABS (grade, roughness, asthenia, breathiness, and strain) scale, Voice Handicap Index-10 (VHI) questionnaire, measurement of maximum phonation time (MPT), and computerized voice analysis including voice intensity, fundamental frequency (F0), jitter, shimmer, and dysphonia severity index (DSI).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Patients who undergo phonosurgery for benign vocal fold lesions.\n\n * Adults (18-90years).\n * Patients who can provide and give informed consent.\n\nExclusion Criteria:\n\n* • Patients without a complete medical record\n\n * Patients who are unable or unwilling to give informed consent\n * Patients younger than 18 years of age or older then 90 years\n * Patients who are pregnant'}, 'identificationModule': {'nctId': 'NCT04319432', 'acronym': 'VR', 'briefTitle': 'Optimal Duration of Voice Rest After Surgery for Benign Vocal Lesions', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tel-Aviv Sourasky Medical Center'}, 'officialTitle': 'Optimal Duration of Voice Rest Voice Following Phonosurgery for Benign Vocal Lesions: Prospective Randomized Study.', 'orgStudyIdInfo': {'id': 'TASMC20YOK037218CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3 days voice rest', 'interventionNames': ['Behavioral: Voice rest']}, {'type': 'EXPERIMENTAL', 'label': '7 days voice rest', 'interventionNames': ['Behavioral: Voice rest']}], 'interventions': [{'name': 'Voice rest', 'type': 'BEHAVIORAL', 'description': 'The first days will take place in hospitalization to assess patient complience to voice rest. Patients will be instructed to continue voice rest at home up to 7 days accourding to group allocation in the study. The confirmation of voice rest will relay on patient report (telephonic approval), after the voice rest period will end.', 'armGroupLabels': ['3 days voice rest', '7 days voice rest']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'YAEL OESTRAICHER, MD', 'role': 'CONTACT', 'email': 'DKYO@netvision.net', 'phone': '0526212179'}], 'facility': 'TASMC', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'centralContacts': [{'name': 'Yael Oestreicher Kedem, MD', 'role': 'CONTACT', 'email': 'DKYO@netvision.net', 'phone': '0526212179'}], 'overallOfficials': [{'name': 'Yael Oestreicher kedem, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'TASMC'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Anonymization of study patients Patient information (I.e. name, ID number, etc.) will be collected and kept confidential throughout the study so that the patients cannot be re-traced or identified. The information will be gathered by the main investigator kept in an encrypted file with a password required for access on the main researcher's computer. Information will not be sent or distributed outside the hospital to anyone."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tel-Aviv Sourasky Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}