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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02321332
Other study ID # MFM2010344
Secondary ID
Status Completed
Phase N/A
First received December 11, 2014
Last updated December 16, 2014
Start date June 2010
Est. completion date June 2013

Study information

Verified date December 2014
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority Egypt: Ministry of Higher Education
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 400
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 8 Years to 50 Years
Eligibility Inclusion Criteria:

- Patients suffering palmar hyperhidrosis

Exclusion Criteria:

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

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
bilateral simultaneous endoscopic thoracic symapthectomy
Patients underwent bilateral simultaneous T2-T3 ganglionectomy using thoracoscopic approach.
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Tmaer Youssef Mohamed

Outcome

Type Measure Description Time frame Safety issue
Primary 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. one year Yes
Secondary 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. one year Yes
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Completed NCT03880266 - A Study of Glycopyrronium Cloth, 2.4% in Patients With Palmar Hyperhidrosis Phase 2
Completed NCT03404570 - Exploratory Study to Assess the Efficacy and Safety of TC-5214 in the Treatment of Subjects With Palmar Hyperhidrosis Phase 2