Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-02-23 @ 1:52 PM
Study NCT ID:
NCT02321332
Status:
COMPLETED
Last Update Posted:
2014-12-22
First Post:
2014-12-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Unilateral Sequential Sympathectomy for Palmar Hyperhidrosis
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': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-16', 'studyFirstSubmitDate': '2014-12-11', 'studyFirstSubmitQcDate': '2014-12-16', 'lastUpdatePostDateStruct': {'date': '2014-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants developing compensatory hyperhidrosis (reflex sweating) following sympathectomy.', 'timeFrame': 'one year', 'description': 'Number pf patients developing compensatory hyperhidrosis (reflex sweating) following sympathectomy. Compensatory hyperhidrosis was graded as "severe" when the patient mentioned that sweating interfered with his or her normal activity, "moderate" when the patient indicated that his or her sweating was not bothersome and "mild" when the patient did not mention dampness or made only a brief reference.'}], 'secondaryOutcomes': [{'measure': 'Number of patients who will be satisfied or unsatisfied regarding the procedure.', 'timeFrame': 'one year', 'description': 'we measure patient satisfaction regarding the procedure by asking the patients to rate their level of satisfaction as very satisfied, somewhat satisfied, somewhat dissatisfied and very dissatisfied. Patients were considered satisfied if they reported being very satisfied or somewhat satisfied.'}]}, 'conditionsModule': {'keywords': ['Palmar hyperhidrosis', 'Endoscopic thoracic sympathectomy'], 'conditions': ['Palmar Hyperhidrosis']}, 'descriptionModule': {'briefSummary': 'Comparison between unilateral sequential and bilateral simultaneous endoscopic thoracic sympathectomy for palmar hyperhidrosis on patients outcomes notably compensatory hyperhidrosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering palmar hyperhidrosis\n\nExclusion Criteria:\n\n* Patients with pleural adhesions, bleeding diathesis, local infection or previous operation for hyperhidrosis'}, 'identificationModule': {'nctId': 'NCT02321332', 'acronym': 'ETS', 'briefTitle': 'Unilateral Sequential Sympathectomy for Palmar Hyperhidrosis', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Unilateral Sequential Versus Bilateral Simultaneous Sympathectomy for Palmar Hyperhidrosis: a Study of 407 Cases.', 'orgStudyIdInfo': {'id': 'MFM2010344'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'B-ETS', 'description': 'Bilateral simultaneous endoscopic thoracic sympathectomy: bilateral simultaneous T2-T3 ganglionectomy.', 'interventionNames': ['Procedure: bilateral simultaneous endoscopic thoracic symapthectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'S-ETS', 'description': 'unilateral sequential endoscopic thoracic sympathectomy: unilateral T2-T3 ganglionectomy of the dominant side followed by T2-T3 ganglionectomy of the other side after 2 months interval', 'interventionNames': ['Procedure: unilateral sequential endoscopic thoracic symapthectomy.']}], 'interventions': [{'name': 'bilateral simultaneous endoscopic thoracic symapthectomy', 'type': 'PROCEDURE', 'description': 'Patients underwent bilateral simultaneous T2-T3 ganglionectomy using thoracoscopic approach.', 'armGroupLabels': ['B-ETS']}, {'name': 'unilateral sequential endoscopic thoracic symapthectomy.', 'type': 'PROCEDURE', 'description': 'Patients underwent unilateral T2-T3 ganglionectomy of the dominant side followed by T2-T3 ganglionectomy of the other side after 2 months interval.', 'armGroupLabels': ['S-ETS']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'tamer youssef, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mansoura Faculty of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tmaer Youssef Mohamed', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'assistant professor of surgery', 'investigatorFullName': 'Tmaer Youssef Mohamed', 'investigatorAffiliation': 'Mansoura University'}}}}