Unilateral Sequential Sympathectomy for Palmar Hyperhidrosis

Overview

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

Full Title of Study: “Unilateral Sequential Versus Bilateral Simultaneous Sympathectomy for Palmar Hyperhidrosis: a Study of 407 Cases.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: June 2013

Interventions

  • Procedure: bilateral simultaneous endoscopic thoracic symapthectomy
    • Patients underwent bilateral simultaneous T2-T3 ganglionectomy using thoracoscopic approach.
  • Procedure: unilateral sequential endoscopic thoracic symapthectomy.
    • Patients underwent unilateral T2-T3 ganglionectomy of the dominant side followed by T2-T3 ganglionectomy of the other side after 2 months interval.

Arms, Groups and Cohorts

  • Active Comparator: B-ETS
    • Bilateral simultaneous endoscopic thoracic sympathectomy: bilateral simultaneous T2-T3 ganglionectomy.
  • Active Comparator: S-ETS
    • 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

Clinical Trial Outcome Measures

Primary Measures

  • Number of participants developing compensatory hyperhidrosis (reflex sweating) following sympathectomy.
    • Time Frame: one year
    • 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 Measures

  • Number of patients who will be satisfied or unsatisfied regarding the procedure.
    • Time Frame: one year
    • 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.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients suffering palmar hyperhidrosis Exclusion Criteria:

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

Gender Eligibility: All

Minimum Age: 8 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Tmaer Youssef Mohamed
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Tmaer Youssef Mohamed, assistant professor of surgery – Mansoura University
  • Overall Official(s)
    • tamer youssef, MD, Study Director, Mansoura Faculty of Medicine

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