HyperhidrosisNCT02728297

Staged Extended Thoracoscopic Sympathicotomy for Palmo-axillo-plantar Hyperhidrosis

A study testing Staged ETS in people with Hyperhidrosis, run by Mansoura University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

Evaluation of staged endoscopic thoracoscopic sympathicotomy in treatment of palmo-axillo-plantar hyperhidrosis Read more about this study

Who is it for?: Ages 16 to 75 years
Conditions the study is for: Hyperhidrosis
What is being tested?: Staged ETS
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: 1 siteEgypt
Study dates: Jan 2010to Mar 2016
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 16 to 75 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

patients with combined palmo-axillo-plantar hyperhidrosis of ASA grade I and II

Who cannot join

Patients under 16 years.
Patients with bradycardia (heart rate <80 beats per minute).
Patients with concomitant lung pathology, frozen mediastinum, pleural effusion, or history of intercostal tube insertion.
Patients with cardiac problems with ejection fraction less than 60%.
Patient suffering from isolated palmo-axillary hyperhidrosis not associated with plantar hyperhidrosis.
Patients suffering from craniofacial hyperhidrosis, either isolated or combined with other areas of hyperhidrosis.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Mansoura university hospital
Al Mansurah, Dakahlia Governorate

Other trials in Egypt

About this study

Official title: Staged Extended Thoracoscopic Sympathicotomy for Palmo-axillo-plantar Hyperhidrosis; a Pilot Study

Evaluation of staged endoscopic thoracoscopic sympathicotomy in treatment of palmo-axillo-plantar hyperhidrosis

Read the detailed description

This is a pilot study that investigates the efficacy of video-assisted endoscopic sympathicotomy from the level of T3 to T12 on combined palmar and plantar hyperhidrosis.

Ablation of ascending sympathetic fibers would help alleviating both types of hyperhidrosis in a single setting.

Conditions: Hyperhidrosis
Being tested: Staged ETS
Medical subject headings: Hyperhidrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Staged ETSProcedure or surgery
Thoracoscopic approach of sympathetic ganglia T3-T12 on one side, retraction of the diaphragm and lung laterally to expose the ganglia then ablation of each ganglion using electrocauterization.

Study groups in NCT02728297
Study group	Role	What they receive
Staged ETS	Experimental	Video-assisted endoscopic sympathicotomy from level of T3 to level of T12 on one side Receives: Procedure: Staged ETS

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in severity of hyperhidrosis on visual analogue scale at 24 months
decrease in the severity of hyperhidrosis, both palmar and plantar, according to visual analogue scale
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Mar 2016

First posted5 Apr 2016 (estimated)
Study startJan 2010
Primary completionFeb 2016
Study completionMar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HyperhidrosisStudies of the same condition, open and under way.
More trials run by Mansoura UniversityThe sponsor's other registered studies.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02728297
Sponsor's protocol ID: mansoura32
Status last verified: Mar 2016
First submitted: 27 Mar 2016
Last updated: 5 Apr 2016
Results posted: No
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Targeting Nociceptors in Hidradenitis Suppurativa
Hidradenitis Suppurativa, Hyperhidrosis
Not yet recruiting
20% Alcohol With Steroid Local Anesthetic Technique Versus Steroid Local Anesthetic Technique Only in Stellate Ganglion Injection in Idiopathic Palmar Hyperhydrosis
Hyperhidrosis
Recruiting
Botulinum Toxin Type A for Frontal Hyperhidrosis
Primary Frontal Hyperhidrosis
Not yet recruitingObservational study
"Incidence of Compensatory Hyperhidrosis After T3 Vs T3-4 Sympathectomy"
Compensatory Hyperhidrosis, Compensatory Sweating
Recruiting
A Polymer Film Device to Treat Excessive Palmar Sweating
Palmar Hyperhidrosis

All Hyperhidrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Staged Extended Thoracoscopic Sympathicotomy for Palmo-axillo-plantar Hyperhidrosis; a Pilot Study
ClinicalTrials.gov ID: NCT02728297
Acronym / sponsor ID: mansoura32
Conditions: Hyperhidrosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Mansoura UniversityUniversity, hospital or other
Study start: Jan 2010
Primary completion: Feb 2016 (actual)
Study completion: Mar 2016 (actual)
First posted: 5 Apr 2016 (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.

Evaluation of staged endoscopic thoracoscopic sympathicotomy in treatment of palmo-axillo-plantar hyperhidrosis

Detailed description

This is a pilot study that investigates the efficacy of video-assisted endoscopic sympathicotomy from the level of T3 to T12 on combined palmar and plantar hyperhidrosis.

Ablation of ascending sympathetic fibers would help alleviating both types of hyperhidrosis in a single setting.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Staged ETS	Experimental	Procedure: Staged ETSVideo-assisted endoscopic sympathicotomy from level of T3 to level of T12 on one side

Who may qualify

Ages: 16 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

patients with combined palmo-axillo-plantar hyperhidrosis of ASA grade I and II

Key exclusion criteria (6 listed)

Patients under 16 years.
Patients with bradycardia (heart rate <80 beats per minute).
Patients with concomitant lung pathology, frozen mediastinum, pleural effusion, or history of intercostal tube insertion.
Patients with cardiac problems with ejection fraction less than 60%.
Patient suffering from isolated palmo-axillary hyperhidrosis not associated with plantar 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
Staged ETSThoracoscopic approach of sympathetic ganglia T3-T12 on one side, retraction of the diaphragm and lung laterally to expose the ganglia then ablation of each ganglion using electrocauterization.	Procedure or surgery	Staged ETS

Primary outcome

Change from baseline in severity of hyperhidrosis on visual analogue scale at 24 months
Time frame: 24 months
decrease in the severity of hyperhidrosis, both palmar and plantar, according to visual analogue scale

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 5 Apr 2016.
Individual participant dataSharing planned: No

Related trials for Hyperhidrosis

RecruitingObservational study
Targeting Nociceptors in Hidradenitis Suppurativa
Hidradenitis Suppurativa, Hyperhidrosis
Not yet recruiting
20% Alcohol With Steroid Local Anesthetic Technique Versus Steroid Local Anesthetic Technique Only in Stellate Ganglion Injection in Idiopathic Palmar Hyperhydrosis
Hyperhidrosis
Recruiting
Botulinum Toxin Type A for Frontal Hyperhidrosis
Primary Frontal Hyperhidrosis
Not yet recruitingObservational study
"Incidence of Compensatory Hyperhidrosis After T3 Vs T3-4 Sympathectomy"
Compensatory Hyperhidrosis, Compensatory Sweating
Recruiting
A Polymer Film Device to Treat Excessive Palmar Sweating
Palmar Hyperhidrosis

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.

Sameh H Emile, M.D principal investigator

Mansoura University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Staged ETS in people with Hyperhidrosis, run by Mansoura University at 1 site in Egypt.

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 6 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 5 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Change from baseline in severity of hyperhidrosis on visual analogue scale at 24 months (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02728297.

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 5 Apr 2016.