Unilateral Sequential Sympathectomy for Palmar Hyperhidrosis
ETS
Unilateral Sequential Versus Bilateral Simultaneous Sympathectomy for Palmar Hyperhidrosis: a Study of 407 Cases.
1 other identifier
interventional
400
0 countries
N/A
Brief Summary
Comparison between unilateral sequential and bilateral simultaneous endoscopic thoracic sympathectomy for palmar hyperhidrosis on patients outcomes notably compensatory hyperhidrosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2010
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 11, 2014
CompletedFirst Posted
Study publicly available on registry
December 22, 2014
CompletedDecember 22, 2014
December 1, 2014
3 years
December 11, 2014
December 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Number of patients who will be satisfied or unsatisfied regarding the procedure.
one year
Study Arms (2)
B-ETS
ACTIVE COMPARATORBilateral simultaneous endoscopic thoracic sympathectomy: bilateral simultaneous T2-T3 ganglionectomy.
S-ETS
ACTIVE COMPARATORunilateral 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
Interventions
Patients underwent bilateral simultaneous T2-T3 ganglionectomy using thoracoscopic approach.
Patients underwent unilateral T2-T3 ganglionectomy of the dominant side followed by T2-T3 ganglionectomy of the other side after 2 months interval.
Eligibility Criteria
You may qualify if:
- Patients suffering palmar hyperhidrosis
You may not qualify if:
- Patients with pleural adhesions, bleeding diathesis, local infection or previous operation for hyperhidrosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- STUDY DIRECTOR
tamer youssef, MD
Mansoura Faculty of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- assistant professor of surgery
Study Record Dates
First Submitted
December 11, 2014
First Posted
December 22, 2014
Study Start
June 1, 2010
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
December 22, 2014
Record last verified: 2014-12