Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT06638827
Status:
RECRUITING
Last Update Posted:
2024-10-15
First Post:
2024-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcome of Bilateral Thoracoscopic Sympathectomy for Patients with Primary Focal Hyperhidrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006945', 'term': 'Hyperhidrosis'}], 'ancestors': [{'id': 'D013543', 'term': 'Sweat Gland Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-10', 'studyFirstSubmitDate': '2024-10-06', 'studyFirstSubmitQcDate': '2024-10-10', 'lastUpdatePostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in Hyperhidrosis Severity as Assessed by the Hyperhidrosis Disease Severity Scale (HDSS) and Gravimetric Sweat Testing', 'timeFrame': 'Immediately After surgery', 'description': 'Participants will be assessed using the HDSS and gravimetric sweat testing. A reduction of ≥ 2 points in HDSS score or a ≥ 50% reduction in sweat production will be considered a successful outcome. Data will be aggregated as the proportion of participants achieving these reductions.'}], 'secondaryOutcomes': [{'measure': 'Change in Quality of Life as Assessed by the Dermatology Life Quality Index (DLQI)', 'timeFrame': 'From baseline to 3 months post-operation.', 'description': 'The DLQI will be administered preoperatively and at 3 months postoperatively to evaluate changes in quality of life. The DLQI is a 10-item questionnaire where higher scores indicate greater impairment. The primary endpoint will be the mean reduction in DLQI score from baseline to 3 months, with a reduction of ≥ 5 points considered clinically significant'}, {'measure': 'Postoperative Pain Levels as Measured by the Visual Analog Scale (VAS)', 'timeFrame': 'From 1 day post-operation to 1 month post-operation.', 'description': 'Postoperative pain will be assessed at regular intervals (1 day, 1 week, and 1 month post-surgery) using the Visual Analog Scale (VAS), a 10-point scale where 0 indicates no pain and 10 indicates severe pain. The primary endpoint will be the mean VAS score at each time point, with pain reduction over time compared'}, {'measure': 'Incidence and Severity of Compensatory Sweating as Measured by the Hyperhidrosis Disease Severity Scale (HDSS)', 'timeFrame': 'from time of operation for 3 months after operation', 'description': 'Participants will report compensatory sweating at 1 month and 3 months post-surgery using the HDSS. The severity of compensatory sweating will be recorded with a scale ranging from 1 (no symptoms) to 4 (severe symptoms that interfere with daily activities). The primary endpoint will be the percentage of patients reporting compensatory sweating and their scores on the HDSS at 3 months'}, {'measure': 'Incidence and Severity of Compensatory Sweating as Measured by the Hyperhidrosis Disease Severity Scale (HDSS)', 'timeFrame': 'From baseline to 3 months post-operation.', 'description': 'Participants will report compensatory sweating at 1 month and 3 months post-surgery using the HDSS. The severity of compensatory sweating will be recorded with a scale ranging from 1 (no symptoms) to 4 (severe symptoms that interfere with daily activities). The primary endpoint will be the percentage of patients reporting compensatory sweating and their scores on the HDSS at 3 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hyperhidrosis', 'Primary focal hyperhidrosis'], 'conditions': ['Hyperhidrosis Primary Focal Palms']}, 'referencesModule': {'references': [{'pmid': '15280848', 'type': 'BACKGROUND', 'citation': 'Hornberger J, Grimes K, Naumann M, Glaser DA, Lowe NJ, Naver H, Ahn S, Stolman LP; Multi-Specialty Working Group on the Recognition, Diagnosis, and Treatment of Primary Focal Hyperhidrosis. Recognition, diagnosis, and treatment of primary focal hyperhidrosis. J Am Acad Dermatol. 2004 Aug;51(2):274-86. doi: 10.1016/j.jaad.2003.12.029. No abstract available.'}, {'pmid': '14759407', 'type': 'BACKGROUND', 'citation': 'Doolabh N, Horswell S, Williams M, Huber L, Prince S, Meyer DM, Mack MJ. Thoracoscopic sympathectomy for hyperhidrosis: indications and results. Ann Thorac Surg. 2004 Feb;77(2):410-4; discussion 414. doi: 10.1016/j.athoracsur.2003.06.003.'}, {'pmid': '36130719', 'type': 'BACKGROUND', 'citation': 'Shabat S, Furman D, Kupietzky A, Srour B, Mordechai-Heyn T, Grinbaum R, Mazeh H, Mizrahi I. Long-term Outcomes of Endoscopic Thoracoscopic Sympathectomy for Primary Focal Palmar Hyperhidrosis: High Patient Satisfaction Rates Despite Significant Compensatory Hyperhidrosis. Surg Laparosc Endosc Percutan Tech. 2022 Dec 1;32(6):730-735. doi: 10.1097/SLE.0000000000001100.'}, {'pmid': '27427529', 'type': 'BACKGROUND', 'citation': 'Milanez de Campos JR, Kauffman P, Gomes O Jr, Wolosker N. Video-Assisted Thoracic Sympathectomy for Hyperhidrosis. Thorac Surg Clin. 2016 Aug;26(3):347-58. doi: 10.1016/j.thorsurg.2016.04.010.'}, {'pmid': '18557587', 'type': 'BACKGROUND', 'citation': 'Solish N, Wang R, Murray CA. Evaluating the patient presenting with hyperhidrosis. Thorac Surg Clin. 2008 May;18(2):133-140. doi: 10.1016/j.thorsurg.2008.01.002.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to examine the overall efficiency of Bilateral Thoracoscopic Sympathectomy on the permanent reduction of Primary focal hyperhidrosis of predilective parts of the body, palms, armpits, face, and soles.', 'detailedDescription': 'The aims of this study are:\n\n1. examine the efficiency of Bilateral Thoracoscopic Sympathectomy (BTS) with different levels of transection among the persons with the Primary focal Hyperhidrosis (PFH)\n2. examine the influence of BTS on cardio-pulmonary function tests in persons with PFH after the operation.\n3. examine the incidence, duration, and intensity of compensatory sweating after BTS among persons with PFH\n4. examine the incidence, duration, localization, and treatment of postoperative pain after BTS among persons with PFH.\n5. determine postoperative complications of BTS among persons with PFH\n6. examine the influence of BTS on quality of life among persons with PFH'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* a. persons with confirmed and estimated Primary Focal Hyperhidrosis accepted to participate in this investigation, fulfilling pre and postoperative questionnaires about BTS effects and quality of life after the operation\n* b. Satisfactory CardioPulmonary Function\n\nExclusion Criteria:\n\n* previous thoracic surgical procedures, rib fractures, massive pneumonias, or pleural empyema\n* Secondary Hyperhidrosis'}, 'identificationModule': {'nctId': 'NCT06638827', 'briefTitle': 'Outcome of Bilateral Thoracoscopic Sympathectomy for Patients with Primary Focal Hyperhidrosis', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'Outcome of Bilateral Thoracoscopic Sympathectomy for Patients with Primary Focal Hyperhidrosis, Sohag University Hospital Experience', 'orgStudyIdInfo': {'id': 'Soh-Med-24-09-09MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patients complaining of primary focal hyperhidrosis', 'description': 'This is a prospective clinical study that includes all patients with Primary Focal Hyperhidrosis, who will be operated on with Bilateral Thoracoscopic Sympathectomy.', 'interventionNames': ['Procedure: Thoracic Sympathectomy']}], 'interventions': [{'name': 'Thoracic Sympathectomy', 'type': 'PROCEDURE', 'otherNames': ['Bilateral Thoracoscopic Sympathectomy'], 'description': 'Bilateral thoracoscopic sympathectomy will be performed with general anesthesia, using single lung ventilation and monopolar cautery for transection of the sympathetic chain.\n\nPersons with PFH who underwent the BTS were classified into three groups, depending the level of transaction of sympathetic chain:\n\n1. transection at the level from the second to the forth thoracic sympathetic ganglion (T2- T4);\n2. transection at the level from the third to the forth thoracic sympathetic ganglion (T3-T4)\n3. transection at the level from the second to the third thoracic sympathetic ganglion (T2-T3)..', 'armGroupLabels': ['Patients complaining of primary focal hyperhidrosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '82738', 'city': 'Sohag', 'state': 'Sohag Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed Mokhtar, Resident Physician', 'role': 'CONTACT', 'email': 'Mohamed94Mokhtar@gmail.com', 'phone': '00201095585485'}, {'name': 'Essam El Badry, Assistant Professor', 'role': 'CONTACT', 'phone': '00201093939202'}, {'name': 'Essam El Badry, Assistant Professor', 'role': 'CONTACT'}, {'name': 'Mohsen Saber, Lecturer', 'role': 'CONTACT'}], 'facility': 'Sohag University', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'centralContacts': [{'name': 'Mohamed Mokhtar, Resident Physician', 'role': 'CONTACT', 'email': 'Mohamed94Mokhtar@gmail.com', 'phone': '00201095585485'}, {'name': 'Essam El Badry, Assistant Professor', 'role': 'CONTACT', 'phone': '00201093939202'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident physician, Cardiothoracic Surgery department', 'investigatorFullName': 'Mohamed Ashraf Mokhtar', 'investigatorAffiliation': 'Sohag University'}}}}