HyperhidrosisNCT02733497
Cardiac Autonomic Changes After Endoscopic Thoracic Sympathectomy For Essential Palmar Hyperhidrosis
A study testing Sympathectomy and Sympathicotomy in people with Hyperhidrosis, run by University of Campania Luigi Vanvitelli.
Trial summary
Essential palmar hyperhidrosis (EPH) is a pathological condition of excessive sweating of the hands due to an unexplained over-activity of the T2 and T3 sympathetic fibers. Endoscopy Thoracoscopic Sympathectomy (ETS) is the treatment of choice in patients with EPH refractory to medical treatment . Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hyperhidrosis
- What is being tested?
- Sympathectomy and Sympathicotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Oct 2014
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age more than 18 years
- Severe hyperhidrosis
Who cannot join
- Contraindications for general anaesthetic procedure and/or for selective endotracheal intubation
- Previous pleural or lung diseases that make difficult the access to pleural cavityù
- Cardiac diseases and/or taking medications with cardiac effects
- Secondary hyperhidrosis including hyperthyroidism, acute and chronic infections, malignancy, and immunologic disorder
- Mild or moderate palmar hyperhidrosis
About this study
Official title: Cardiac Autonomic Changes After Endoscopic Thoracic Sympathectomy For Essential Palmar Hyperhidrosis: Results Of A Prospective, Randomized Study
Essential palmar hyperhidrosis (EPH) is a pathological condition of excessive sweating of the hands due to an unexplained over-activity of the T2 and T3 sympathetic fibers. Endoscopy Thoracoscopic Sympathectomy (ETS) is the treatment of choice in patients with EPH refractory to medical treatment .
The cardiac sympathetic activity is mainly controlled by cervical sympathetic fibers but anatomic studies have showed that "accessory" fibers from the T2 and T3 sympathetic ganglia come to the heart and influence its function.
Read more
Heart Rate Variability (HRV) is a simple and non-invasive method based on electrocardiogram to evaluate the sympathovagal balance at the sino-atrial level. Several studies have found that ETS caused a decrease of heart rate (HR), an increase of HR variability (HRV) and a shift of sympathovagal balance toward parasympathetic tone but remains unclear if these changes are associated with the extend of ETS.
Thus, in the present study the investigator performed a prospective analysis of HRV function in patients with EPH undergoing different sympathetic denervations as sympathectomy and sympathicotomy with the hypothesis that cardiac autonomic changes could be associated with the extend of sympathetic resection.
Read the detailed description
It was an unicenter prospective study performed at Thoracic Surgery Unit of Second University of Naples. Patients with severe EPH were randomly assigned to Sympathectomy or Sympathicotomy Group in 1:1 ratio .
Bilateral ETSs were performed in a one-stage procedure by the same surgeon. General anaesthesia using single-lung ventilation technique was performed and patient was placed in standard lateral thoracotomy position. Immediately after the induction of anaesthesia, a local infiltration with 2% lidocaine and epinephrine was injected at each port 5 minutes before the incision to reduce postoperative pain. The first port was placed in the 3th intercostal space below and anterior to inferior angle of scapula and through that a 10 mm 30 degree camera was inserted. A second 5 mm working port was placed at the same intercostal space in the anterior axillary line. After identification of sympathetic chain, in Sympathectomy Group the T3 ganglion was excised at the top of the third rib while in Sympathicotomy Group the sympathetic chain was resected between T2-T3 ganglia at the same level but the T3 ganglion was left intact. At the end of the procedure, a 16 F drainage was inserted through the port and the lung was re-inflated to allow the air drainage from pleural cavity and to prevent pneumothorax. The drain was subsequently removed.
All measurements on cardiac autonomic function were performed one week before ETS and different post-operative time-points (7 days, 1, 3 and 6 months after ETS). The results were prospectively registered and then retrospectively analyzed.
- Conditions
- Hyperhidrosis
- Being tested
- Sympathectomy, Sympathicotomy
- Keywords
- sympathectomy, sympathicotomy, heart rate variability,
- Medical subject headings
- Hyperhidrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SympathectomyProcedure or surgery
Resection of ganglia at T3 level
SympathicotomyProcedure or surgery
Cutting of symptahetic chain at T3 level without ganglia excision
| Study group | Role | What they receive |
|---|---|---|
| Sympathectomy Group | Active comparator | Excision of ganglia at T3 level Receives: Procedure: Sympathectomy |
| Sympathicotomy Group | Active comparator | Resection of sympathetic chain at T3 level Receives: Procedure: Sympathicotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate (HR) measured in beats/min
Measured: 7 days, 1, 3 and 6 months after operation
Secondary outcomes (2)
Post-operative complications
Measured: Post-operative time and 7 days, 1, 3 and 6 months after operation
Compensatory hyperhidrosis measured with a scale ranging from 0 (absent) to 3 (severe)
Measured: 1, 3 and 6 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startJan 2012
- Primary completionSep 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campania Luigi Vanvitelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alfonso Fiorelli, University of Campania Luigi Vanvitelli
- Investigators
- Mario Santini, MD, Study chair, University of Campania Luigi Vanvitelli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02733497
- Sponsor's protocol ID
- 1185/2011
- Status last verified
- Apr 2016
- First submitted
- 5 Apr 2016
- Last updated
- 12 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Katara AN, Domino JP, Cheah WK, So JB, Ning C, Lomanto D. Comparing T2 and T2-T3 ablation in thoracoscopic sympathectomy for palmar hyperhidrosis: a randomized control trial. Surg Endosc. 2007 Oct;21(10):1768-71. doi: 10.1007/s00464-007-9241-9. Epub 2007 Apr 3.
PubMed 17404794Tedoriya T, Sakagami S, Ueyama T, Thompson L, Hetzer R. Influences of bilateral endoscopic transthoracic sympathicotomy on cardiac autonomic nervous activity. Eur J Cardiothorac Surg. 1999 Feb;15(2):194-8. doi: 10.1016/s1010-7940(98)00309-1.
PubMed 10219553Cruz J, Sousa J, Oliveira AG, Silva-Carvalho L. Effects of endoscopic thoracic sympathectomy for primary hyperhidrosis on cardiac autonomic nervous activity. J Thorac Cardiovasc Surg. 2009 Mar;137(3):664-9. doi: 10.1016/j.jtcvs.2008.07.021. Epub 2008 Sep 24.
PubMed 19258086Fiorelli A, Messina G, Chiodini P, Costanzo S, Viggiano A, Monda M, Vicidomini G, Santini M. Cardiac Autonomic Changes After Thoracic Sympathectomy: A Prospective, Randomized Study. Ann Thorac Surg. 2017 Jan;103(1):216-224. doi: 10.1016/j.athoracsur.2016.10.055. Epub 2016 Nov 23.
PubMed 27889103
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Autonomic Changes After Endoscopic Thoracic Sympathectomy For Essential Palmar Hyperhidrosis: Results Of A Prospective, Randomized Study
- ClinicalTrials.gov ID
- NCT02733497
- Acronym / sponsor ID
- 1185/2011
- Conditions
- Hyperhidrosis
- Keywords
- sympathectomy, sympathicotomy, heart rate variability,
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Campania Luigi VanvitelliUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 11 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.
Essential palmar hyperhidrosis (EPH) is a pathological condition of excessive sweating of the hands due to an unexplained over-activity of the T2 and T3 sympathetic fibers. Endoscopy Thoracoscopic Sympathectomy (ETS) is the treatment of choice in patients with EPH refractory to medical treatment .
The cardiac sympathetic activity is mainly controlled by cervical sympathetic fibers but anatomic studies have showed that "accessory" fibers from the T2 and T3 sympathetic ganglia come to the heart and influence its function.
Heart Rate Variability (HRV) is a simple and non-invasive method based on electrocardiogram to evaluate the sympathovagal balance at the sino-atrial level. Several studies have found that ETS caused a decrease of heart rate (HR), an increase of HR variability (HRV) and a shift of sympathovagal balance toward parasympathetic tone but remains unclear if these changes are associated with the extend of ETS.
Thus, in the present study the investigator performed a prospective analysis of HRV function in patients with EPH undergoing different sympathetic denervations as sympathectomy and sympathicotomy with the hypothesis that cardiac autonomic changes could be associated with the extend of sympathetic resection.
Detailed description
It was an unicenter prospective study performed at Thoracic Surgery Unit of Second University of Naples. Patients with severe EPH were randomly assigned to Sympathectomy or Sympathicotomy Group in 1:1 ratio .
Bilateral ETSs were performed in a one-stage procedure by the same surgeon. General anaesthesia using single-lung ventilation technique was performed and patient was placed in standard lateral thoracotomy position. Immediately after the induction of anaesthesia, a local infiltration with 2% lidocaine and epinephrine was injected at each port 5 minutes before the incision to reduce postoperative pain. The first port was placed in the 3th intercostal space below and anterior to inferior angle of scapula and through that a 10 mm 30 degree camera was inserted. A second 5 mm working port was placed at the same intercostal space in the anterior axillary line. After identification of sympathetic chain, in Sympathectomy Group the T3 ganglion was excised at the top of the third rib while in Sympathicotomy Group the sympathetic chain was resected between T2-T3 ganglia at the same level but the T3 ganglion was left intact. At the end of the procedure, a 16 F drainage was inserted through the port and the lung was re-inflated to allow the air drainage from pleural cavity and to prevent pneumothorax. The drain was subsequently removed.
All measurements on cardiac autonomic function were performed one week before ETS and different post-operative time-points (7 days, 1, 3 and 6 months after ETS). The results were prospectively registered and then retrospectively analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sympathectomy Group | Active comparator | Procedure: SympathectomyExcision of ganglia at T3 level |
| Sympathicotomy Group | Active comparator | Procedure: SympathicotomyResection of sympathetic chain at T3 level |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age more than 18 years
- Severe hyperhidrosis
Key exclusion criteria (5 listed)
- Contraindications for general anaesthetic procedure and/or for selective endotracheal intubation
- Previous pleural or lung diseases that make difficult the access to pleural cavityù
- Cardiac diseases and/or taking medications with cardiac effects
- Secondary hyperhidrosis including hyperthyroidism, acute and chronic infections, malignancy, and immunologic disorder
- Mild or moderate palmar 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 |
|---|---|---|
| SympathectomyResection of ganglia at T3 level | Procedure or surgery | Sympathectomy Group |
| SympathicotomyCutting of symptahetic chain at T3 level without ganglia excision | Procedure or surgery | Sympathicotomy Group |
Primary outcome
Heart Rate (HR) measured in beats/min
Time frame: 7 days, 1, 3 and 6 months after operation
2 secondary outcomes
Post-operative complications
Time frame: Post-operative time and 7 days, 1, 3 and 6 months after operation
Compensatory hyperhidrosis measured with a scale ranging from 0 (absent) to 3 (severe)
Time frame: 1, 3 and 6 months after operation
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 12 Apr 2016.
- Background: PubMed 17404794Katara AN, Domino JP, Cheah WK, So JB, Ning C, Lomanto D. Comparing T2 and T2-T3 ablation in thoracoscopic sympathectomy for palmar hyperhidrosis: a randomized control trial. Surg Endosc. 2007 Oct;21(10):1768-71. doi: 10.1007/s00464-007-9241-9. Epub 2007 Apr 3.
- Background: PubMed 10219553Tedoriya T, Sakagami S, Ueyama T, Thompson L, Hetzer R. Influences of bilateral endoscopic transthoracic sympathicotomy on cardiac autonomic nervous activity. Eur J Cardiothorac Surg. 1999 Feb;15(2):194-8. doi: 10.1016/s1010-7940(98)00309-1.
- Background: PubMed 19258086Cruz J, Sousa J, Oliveira AG, Silva-Carvalho L. Effects of endoscopic thoracic sympathectomy for primary hyperhidrosis on cardiac autonomic nervous activity. J Thorac Cardiovasc Surg. 2009 Mar;137(3):664-9. doi: 10.1016/j.jtcvs.2008.07.021. Epub 2008 Sep 24.
- Derived from this study: PubMed 27889103Fiorelli A, Messina G, Chiodini P, Costanzo S, Viggiano A, Monda M, Vicidomini G, Santini M. Cardiac Autonomic Changes After Thoracic Sympathectomy: A Prospective, Randomized Study. Ann Thorac Surg. 2017 Jan;103(1):216-224. doi: 10.1016/j.athoracsur.2016.10.055. Epub 2016 Nov 23.
- Individual participant dataSharing planned: No
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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.
Mario Santini, MD study chair
University of Campania Luigi Vanvitelli
Questions about this trial
What is this clinical trial studying?
A study testing Sympathectomy and Sympathicotomy in people with Hyperhidrosis, run by University of Campania Luigi Vanvitelli.
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 2 inclusion and 5 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 12 Apr 2016. 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?
Heart Rate (HR) measured in beats/min (time frame: 7 days, 1, 3 and 6 months after operation). 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 NCT02733497, which also lists 4 linked publications.
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 12 Apr 2016.