Compensatory HyperhidrosisNCT01295853
T3 Versus T4 Sympathicotomy for Treatment of Primary Palmar Hyperhidrosis
A study testing t3 sympathicotomy and t4 symapthicotomy in people with Compensatory Hyperhidrosis and Recurrence, run by Mansoura University at 1 site in Egypt.
Trial summary
T3 versus T4 as a primary treatment for palmer hyperhydrosis and effect on postoperative compensatory hyperhydrosis Read more about this study
- Who is it for?
- Ages 15 to 38 years
- Conditions the study is for
- Compensatory Hyperhidrosis, Recurrence
- What is being tested?
- t3 sympathicotomy and t4 symapthicotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteEgypt
- Study dates
- Feb 2008to Sep 2010
- 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 15 to 38 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with primary palmar hyperhidrosis
Who cannot join
- Patients with pleural adhesion
- Bleeding diathesis
- Local infection
- Patients with certain anatomic anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: T3 Versus T4 Sympathicotomy for Treatment of Primary Palmar Hyperhidrosis: a Prospective Randomized Study
T3 versus T4 as a primary treatment for palmer hyperhydrosis and effect on postoperative compensatory hyperhydrosis
Read the detailed description
Palmar hyperhidrosis (PH) is a benign sympathetic disorder that does not threaten health but affects daily activities, and may causes social withdrawal and even depression.1 An incidence of up to 1% has been reported by various series in the literature. The incidence in men and women is the same; however women are more likely to seek medical attention, which may explain the higher incidence of female patients in most surgical series [2,3]. Although various treatment options are available, including topical and systemic therapies, iontophoresis, regional nerve block, and botulinum toxin injection, each has its limitations 4. Video-assisted thoracoscopic sympathetic surgery is currently a worldwide accepted treatment of primary palmar hyperhidrosis (PH) 5. However, compensatory hyperhidrosis (CH) is the most common and serious side effect that occurs in 30-70% of patients after T2 or T2-3 sympathectomy 6. For that now T2 sympathetic surgeries are seldom used in PH. Procedures that involve T3 or/and T4 sympathetic ganglions are widely accepted in many centers with favourable results.5 But some patients still present with certain degrees of CH or over dry hands after operation 7, 8.
The aim of this study is to compare the two methods for the treatment of PH, in which the sympathetic chain was transected in merely one segment, on the level of either the third or the fourth ribbed, defined as T3 sympathicotomy or T4 sympathicotomy, respectively. Emphasis was placed on the evaluation of the efficacy, side effects, and patients' satisfaction rate to these two types of surgical therapy.
- Conditions
- Compensatory Hyperhidrosis, Recurrence
- Being tested
- t3 sympathicotomy, t4 symapthicotomy
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
t3 sympathicotomyProcedure or surgery
Also called sympathectomy
The sympathetic chain was identified at the level of the crossing of the third or fourth costal heads after dissection of the parietal pleura and completely divided about 1 cm wide at the upper margin of the rib. With assistance of anaesthesia team we reinflate the lung totally in sequence with removal of the trocars. The same procedure was performed on the opposite side and ablation of the sympathetic chain overlying the rib was performed bilaterally. At the end of surgery, a postoperative chest x-ray was routinely taken to rule out pneumothorax or hemothorax.
t4 symapthicotomyProcedure or surgery
Also called sympathectomy
The sympathetic chain was identified at the level of the crossing of the third or fourth costal heads after dissection of the parietal pleura and completely divided about 1 cm wide at the upper margin of the rib. With assistance of anaesthesia team we reinflate the lung totally in sequence with removal of the trocars. The same procedure was performed on the opposite side and ablation of the sympathetic chain overlying the rib was performed bilaterally. At the end of surgery, a postoperative chest x-ray was routinely taken to rule out pneumothorax or hemothorax.
| Study group | Role | What they receive |
|---|---|---|
| t3 sympathicotomy | Active comparator | The sympathetic chain was identified at the level of the crossing of the third or fourth costal heads after dissection of the parietal pleura and completely divided about 1 cm wide at the upper margin of the rib. With assistance of anaesthesia team we reinflate the lung totally in sequence with removal of the trocars. The same procedure was performed on the opposite side and ablation of the sympathetic chain overlying the rib was performed bilaterally. At the end of surgery, a postoperative chest x-ray was routinely taken to rule out pneumothorax or hemothorax. Receives: Procedure: t3 sympathicotomy; Procedure: t4 symapthicotomy |
| t4 sypathicotomy | Active comparator | The sympathetic chain was identified at the level of the crossing of the third or fourth costal heads after dissection of the parietal pleura and completely divided about 1 cm wide at the upper margin of the rib. With assistance of anaesthesia team we reinflate the lung totally in sequence with removal of the trocars. The same procedure was performed on the opposite side and ablation of the sympathetic chain overlying the rib was performed bilaterally. At the end of surgery, a postoperative chest x-ray was routinely taken to rule out pneumothorax or hemothorax. Receives: Procedure: t4 symapthicotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative compensatory hyperhidrosis
CH remains the most common and distressing complication postsympathicotomy and many efforts have been made to ovoid its happening .Chou et al, 2 suggested that the underlying mechanism of CH may be due to a reflex response in sweating centre in hypothalamus but the exact mechanism beyond this phenomenon remain unclear.
Measured: 2008-2010
Secondary outcomes (1)
improvement of planter sweating assessment of overdry hands early postoperative complication ( pneumothorax,,,,,) recurrance
The recurrence rate in T4 group was occurring in 2 patients (2.8%), whereas one recurrence found in T3 group (1.5%).
Kim et al 4, reported a 4.2 % of patients undergo T3 sympathicotomy complaining of gustatory sweating in a study carried out on 56 patients. However In our study there was no occurrence of postsympathicotomy gustatory hyperhidrosis and this may be due to the small numbers in our series.
Measured: 2008-2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study startFeb 2008
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Compensatory 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Investigators
- ahmed negm, md, Principal investigator, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01295853
- Sponsor's protocol ID
- AMRO2345
- Status last verified
- Feb 2008
- First submitted
- 14 Feb 2011
- Last updated
- 15 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chou SH, Kao EL, Lin CC, Chang YT, Huang MF. The importance of classification in sympathetic surgery and a proposed mechanism for compensatory hyperhidrosis: experience with 464 cases. Surg Endosc. 2006 Nov;20(11):1749-53. doi: 10.1007/s00464-005-0829-7. Epub 2006 Oct 5.
PubMed 17024534
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T3 Versus T4 Sympathicotomy for Treatment of Primary Palmar Hyperhidrosis: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT01295853
- Acronym / sponsor ID
- AMRO2345
- Conditions
- Compensatory Hyperhidrosis, Recurrence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 15 Feb 2011 (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.
T3 versus T4 as a primary treatment for palmer hyperhydrosis and effect on postoperative compensatory hyperhydrosis
Detailed description
Palmar hyperhidrosis (PH) is a benign sympathetic disorder that does not threaten health but affects daily activities, and may causes social withdrawal and even depression.1 An incidence of up to 1% has been reported by various series in the literature. The incidence in men and women is the same; however women are more likely to seek medical attention, which may explain the higher incidence of female patients in most surgical series [2,3]. Although various treatment options are available, including topical and systemic therapies, iontophoresis, regional nerve block, and botulinum toxin injection, each has its limitations 4. Video-assisted thoracoscopic sympathetic surgery is currently a worldwide accepted treatment of primary palmar hyperhidrosis (PH) 5. However, compensatory hyperhidrosis (CH) is the most common and serious side effect that occurs in 30-70% of patients after T2 or T2-3 sympathectomy 6. For that now T2 sympathetic surgeries are seldom used in PH. Procedures that involve T3 or/and T4 sympathetic ganglions are widely accepted in many centers with favourable results.5 But some patients still present with certain degrees of CH or over dry hands after operation 7, 8.
The aim of this study is to compare the two methods for the treatment of PH, in which the sympathetic chain was transected in merely one segment, on the level of either the third or the fourth ribbed, defined as T3 sympathicotomy or T4 sympathicotomy, respectively. Emphasis was placed on the evaluation of the efficacy, side effects, and patients' satisfaction rate to these two types of surgical therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| t3 sympathicotomy | Active comparator | Procedure: t3 sympathicotomy, Procedure: t4 symapthicotomyThe sympathetic chain was identified at the level of the crossing of the third or fourth costal heads after dissection of the parietal pleura and completely divided about 1 cm wide at the upper margin of the rib. With assistance of anaesthesia team we reinflate the lung totally in sequence with removal of the trocars. The same procedure was performed on the opposite side and ablation of the sympathetic chain overlying the rib was performed bilaterally. At the end of surgery, a postoperative chest x-ray was routinely taken to rule out pneumothorax or hemothorax. |
| t4 sypathicotomy | Active comparator | Procedure: t4 symapthicotomyThe sympathetic chain was identified at the level of the crossing of the third or fourth costal heads after dissection of the parietal pleura and completely divided about 1 cm wide at the upper margin of the rib. With assistance of anaesthesia team we reinflate the lung totally in sequence with removal of the trocars. The same procedure was performed on the opposite side and ablation of the sympathetic chain overlying the rib was performed bilaterally. At the end of surgery, a postoperative chest x-ray was routinely taken to rule out pneumothorax or hemothorax. |
Who may qualify
- Ages
- 15 to 38 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Patients with primary palmar hyperhidrosis
Key exclusion criteria (4 listed)
- Patients with pleural adhesion
- Bleeding diathesis
- Local infection
- Patients with certain anatomic anomalies
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 |
|---|---|---|
| t3 sympathicotomyAlso: sympathectomyThe sympathetic chain was identified at the level of the crossing of the third or fourth costal heads after dissection of the parietal pleura and completely divided about 1 cm wide at the upper margin of the rib. With assistance of anaesthesia team we reinflate the lung totally in sequence with removal of the trocars. The same procedure was performed on the opposite side and ablation of the sympathetic chain overlying the rib was performed bilaterally. At the end of surgery, a postoperative chest x-ray was routinely taken to rule out pneumothorax or hemothorax. | Procedure or surgery | t3 sympathicotomy |
| t4 symapthicotomyAlso: sympathectomyThe sympathetic chain was identified at the level of the crossing of the third or fourth costal heads after dissection of the parietal pleura and completely divided about 1 cm wide at the upper margin of the rib. With assistance of anaesthesia team we reinflate the lung totally in sequence with removal of the trocars. The same procedure was performed on the opposite side and ablation of the sympathetic chain overlying the rib was performed bilaterally. At the end of surgery, a postoperative chest x-ray was routinely taken to rule out pneumothorax or hemothorax. | Procedure or surgery | t3 sympathicotomy, t4 sypathicotomy |
Primary outcome
postoperative compensatory hyperhidrosis
Time frame: 2008-2010
CH remains the most common and distressing complication postsympathicotomy and many efforts have been made to ovoid its happening .Chou et al, 2 suggested that the underlying mechanism of CH may be due to a reflex response in sweating centre in hypothalamus but the exact mechanism beyond this phenomenon remain unclear.
1 secondary outcome
improvement of planter sweating assessment of overdry hands early postoperative complication ( pneumothorax,,,,,) recurrance
Time frame: 2008-2010
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 15 Feb 2011.
- Background: PubMed 17024534Chou SH, Kao EL, Lin CC, Chang YT, Huang MF. The importance of classification in sympathetic surgery and a proposed mechanism for compensatory hyperhidrosis: experience with 464 cases. Surg Endosc. 2006 Nov;20(11):1749-53. doi: 10.1007/s00464-005-0829-7. Epub 2006 Oct 5.
Related trials for Compensatory Hyperhidrosis
Not yet recruitingObservational study
"Incidence of Compensatory Hyperhidrosis After T3 Vs T3-4 Sympathectomy"
Compensatory Hyperhidrosis, Compensatory Sweating
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.
ahmed negm, md principal investigator
Mansoura University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing t3 sympathicotomy and t4 symapthicotomy in people with Compensatory Hyperhidrosis and Recurrence, 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 4 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 15 Feb 2011. 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?
postoperative compensatory hyperhidrosis (time frame: 2008-2010). 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 NCT01295853, which also lists 1 linked publication.
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 15 Feb 2011.