Palmar HyperhidrosisETSNCT02321332
Unilateral Sequential Sympathectomy for Palmar Hyperhidrosis
A study testing bilateral simultaneous endoscopic thoracic symapthectomy and unilateral sequential endoscopic thoracic symapthectomy. in people with Palmar Hyperhidrosis, run by Tmaer Youssef Mohamed.
Trial summary
Comparison between unilateral sequential and bilateral simultaneous endoscopic thoracic sympathectomy for palmar hyperhidrosis on patients outcomes notably compensatory hyperhidrosis. Read more about this study
- Who is it for?
- Ages 8 to 50 years
- Conditions the study is for
- Palmar Hyperhidrosis
- What is being tested?
- bilateral simultaneous endoscopic thoracic symapthectomy and unilateral sequential endoscopic thoracic symapthectomy.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients suffering palmar hyperhidrosis
Who cannot join
- Patients with pleural adhesions, bleeding diathesis, local infection or previous operation for hyperhidrosis
About this study
Official title: Unilateral Sequential Versus Bilateral Simultaneous Sympathectomy for Palmar Hyperhidrosis: a Study of 407 Cases.
Comparison between unilateral sequential and bilateral simultaneous endoscopic thoracic sympathectomy for palmar hyperhidrosis on patients outcomes notably compensatory hyperhidrosis.
- Conditions
- Palmar Hyperhidrosis
- Being tested
- bilateral simultaneous endoscopic thoracic symapthectomy, unilateral sequential endoscopic thoracic symapthectomy.
- Keywords
- Palmar hyperhidrosis, Endoscopic thoracic sympathectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral simultaneous endoscopic thoracic symapthectomyProcedure or surgery
Patients underwent bilateral simultaneous T2-T3 ganglionectomy using thoracoscopic approach.
unilateral sequential endoscopic thoracic symapthectomy.Procedure or surgery
Patients underwent unilateral T2-T3 ganglionectomy of the dominant side followed by T2-T3 ganglionectomy of the other side after 2 months interval.
| Study group | Role | What they receive |
|---|---|---|
| B-ETS | Active comparator | Bilateral simultaneous endoscopic thoracic sympathectomy: bilateral simultaneous T2-T3 ganglionectomy. Receives: 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 Receives: Procedure: unilateral sequential endoscopic thoracic symapthectomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (1)
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2014 (estimated)
- Study startJun 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palmar HyperhidrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tmaer Youssef Mohamed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tmaer Youssef Mohamed, Mansoura University
- Investigators
- tamer youssef, MD, Study director, Mansoura Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02321332
- Sponsor's protocol ID
- MFM2010344
- Acronym
- ETS
- Status last verified
- Dec 2014
- First submitted
- 11 Dec 2014
- Last updated
- 22 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unilateral Sequential Versus Bilateral Simultaneous Sympathectomy for Palmar Hyperhidrosis: a Study of 407 Cases.
- ClinicalTrials.gov ID
- NCT02321332
- Acronym / sponsor ID
- ETS / MFM2010344
- Conditions
- Palmar Hyperhidrosis
- Keywords
- Palmar hyperhidrosis, Endoscopic thoracic sympathectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Tmaer Youssef MohamedUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison between unilateral sequential and bilateral simultaneous endoscopic thoracic sympathectomy for palmar hyperhidrosis on patients outcomes notably compensatory hyperhidrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| B-ETS | Active comparator | Procedure: bilateral simultaneous endoscopic thoracic symapthectomyBilateral simultaneous endoscopic thoracic sympathectomy: bilateral simultaneous T2-T3 ganglionectomy. |
| S-ETS | Active comparator | Procedure: unilateral sequential endoscopic thoracic symapthectomy.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 |
Who may qualify
- Ages
- 8 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients suffering palmar hyperhidrosis
Key exclusion criteria (1 listed)
- Patients with pleural adhesions, bleeding diathesis, local infection or previous operation for hyperhidrosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bilateral simultaneous endoscopic thoracic symapthectomyPatients underwent bilateral simultaneous T2-T3 ganglionectomy using thoracoscopic approach. | Procedure or surgery | B-ETS |
| 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. | Procedure or surgery | S-ETS |
Primary outcome
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.
1 secondary outcome
Number of patients who will be satisfied or unsatisfied regarding the procedure.
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
tamer youssef, MD study director
Mansoura Faculty of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing bilateral simultaneous endoscopic thoracic symapthectomy and unilateral sequential endoscopic thoracic symapthectomy. in people with Palmar Hyperhidrosis, run by Tmaer Youssef Mohamed.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants developing compensatory hyperhidrosis (reflex sweating) following sympathectomy. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2014.