NCT02321332

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

December 11, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 22, 2014

Completed
Last Updated

December 22, 2014

Status Verified

December 1, 2014

Enrollment Period

3 years

First QC Date

December 11, 2014

Last Update Submit

December 16, 2014

Conditions

Keywords

Palmar hyperhidrosisEndoscopic thoracic sympathectomy

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 COMPARATOR

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

Procedure: bilateral simultaneous endoscopic thoracic symapthectomy

S-ETS

ACTIVE COMPARATOR

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.

Interventions

Patients underwent bilateral simultaneous T2-T3 ganglionectomy using thoracoscopic approach.

B-ETS

Patients underwent unilateral T2-T3 ganglionectomy of the dominant side followed by T2-T3 ganglionectomy of the other side after 2 months interval.

S-ETS

Eligibility Criteria

Age8 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

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

  • tamer youssef, MD

    Mansoura Faculty of Medicine

    STUDY DIRECTOR

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