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Unilateral Sequential Sympathectomy for Palmar Hyperhidrosis (ETS)

Primary Purpose

Palmar Hyperhidrosis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
bilateral simultaneous endoscopic thoracic symapthectomy
unilateral sequential endoscopic thoracic symapthectomy.
Sponsored by
Tmaer Youssef Mohamed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Palmar Hyperhidrosis focused on measuring Palmar hyperhidrosis, Endoscopic thoracic sympathectomy

Eligibility Criteria

8 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients suffering palmar hyperhidrosis

Exclusion Criteria:

  • Patients with pleural adhesions, bleeding diathesis, local infection or previous operation for hyperhidrosis

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    B-ETS

    S-ETS

    Arm Description

    Bilateral simultaneous endoscopic thoracic sympathectomy: bilateral simultaneous T2-T3 ganglionectomy.

    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

    Outcomes

    Primary Outcome Measures

    Number of participants developing compensatory hyperhidrosis (reflex sweating) following sympathectomy.
    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.

    Secondary Outcome Measures

    Number of patients who will be satisfied or unsatisfied regarding the procedure.
    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.

    Full Information

    First Posted
    December 11, 2014
    Last Updated
    December 16, 2014
    Sponsor
    Tmaer Youssef Mohamed
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02321332
    Brief Title
    Unilateral Sequential Sympathectomy for Palmar Hyperhidrosis
    Acronym
    ETS
    Official Title
    Unilateral Sequential Versus Bilateral Simultaneous Sympathectomy for Palmar Hyperhidrosis: a Study of 407 Cases.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2010 (undefined)
    Primary Completion Date
    June 2013 (Actual)
    Study Completion Date
    June 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Tmaer Youssef Mohamed

    4. Oversight

    5. Study Description

    Brief Summary
    Comparison between unilateral sequential and bilateral simultaneous endoscopic thoracic sympathectomy for palmar hyperhidrosis on patients outcomes notably compensatory hyperhidrosis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Palmar Hyperhidrosis
    Keywords
    Palmar hyperhidrosis, Endoscopic thoracic sympathectomy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    400 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    B-ETS
    Arm Type
    Active Comparator
    Arm Description
    Bilateral simultaneous endoscopic thoracic sympathectomy: bilateral simultaneous T2-T3 ganglionectomy.
    Arm Title
    S-ETS
    Arm Type
    Active Comparator
    Arm 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
    Intervention Type
    Procedure
    Intervention Name(s)
    bilateral simultaneous endoscopic thoracic symapthectomy
    Intervention Description
    Patients underwent bilateral simultaneous T2-T3 ganglionectomy using thoracoscopic approach.
    Intervention Type
    Procedure
    Intervention Name(s)
    unilateral sequential endoscopic thoracic symapthectomy.
    Intervention Description
    Patients underwent unilateral T2-T3 ganglionectomy of the dominant side followed by T2-T3 ganglionectomy of the other side after 2 months interval.
    Primary Outcome Measure Information:
    Title
    Number of participants developing compensatory hyperhidrosis (reflex sweating) following sympathectomy.
    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.
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    Number of patients who will be satisfied or unsatisfied regarding the procedure.
    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.
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients suffering palmar hyperhidrosis Exclusion Criteria: Patients with pleural adhesions, bleeding diathesis, local infection or previous operation for hyperhidrosis
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    tamer youssef, MD
    Organizational Affiliation
    Mansoura Faculty of Medicine
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Unilateral Sequential Sympathectomy for Palmar Hyperhidrosis

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