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Unilateral Sequential Sympathectomy for Palmar Hyperhidrosis (ETS)

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ClinicalTrials.gov Identifier: NCT02321332
Recruitment Status : Completed
First Posted : December 22, 2014
Last Update Posted : December 22, 2014
Sponsor:
Information provided by (Responsible Party):
Tmaer Youssef Mohamed, Mansoura University

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

Condition or disease Intervention/treatment Phase
Palmar Hyperhidrosis Procedure: bilateral simultaneous endoscopic thoracic symapthectomy Procedure: unilateral sequential endoscopic thoracic symapthectomy. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Unilateral Sequential Versus Bilateral Simultaneous Sympathectomy for Palmar Hyperhidrosis: a Study of 407 Cases.
Study Start Date : June 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Active Comparator: B-ETS
Bilateral simultaneous endoscopic thoracic sympathectomy: bilateral simultaneous T2-T3 ganglionectomy.
Procedure: bilateral simultaneous endoscopic thoracic symapthectomy
Patients underwent bilateral simultaneous T2-T3 ganglionectomy using thoracoscopic approach.

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
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.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



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Ages Eligible for Study:   8 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients suffering palmar hyperhidrosis

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02321332


Sponsors and Collaborators
Tmaer Youssef Mohamed
Investigators
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Study Director: tamer youssef, MD Mansoura Faculty of Medicine

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Responsible Party: Tmaer Youssef Mohamed, assistant professor of surgery, Mansoura University
ClinicalTrials.gov Identifier: NCT02321332     History of Changes
Other Study ID Numbers: MFM2010344
First Posted: December 22, 2014    Key Record Dates
Last Update Posted: December 22, 2014
Last Verified: December 2014
Keywords provided by Tmaer Youssef Mohamed, Mansoura University:
Palmar hyperhidrosis
Endoscopic thoracic sympathectomy
Additional relevant MeSH terms:
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Hyperhidrosis
Sweat Gland Diseases
Skin Diseases