T3 Versus T4 Sympathicotomy for Treatment of Primary Palmar Hyperhidrosis

This study has been completed.
Sponsor:
Information provided by:
Mansoura University
ClinicalTrials.gov Identifier:
NCT01295853
First received: February 14, 2011
Last updated: NA
Last verified: February 2008
History: No changes posted
  Purpose

T3 versus T4 as a primary treatment for palmer hyperhydrosis and effect on postoperative compensatory hyperhydrosis


Condition Intervention
Compensatory Hyperhidrosis
Recurrence
Procedure: t3 sympathicotomy
Procedure: t4 symapthicotomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: T3 Versus T4 Sympathicotomy for Treatment of Primary Palmar Hyperhidrosis: a Prospective Randomized Study

Resource links provided by NLM:


Further study details as provided by Mansoura University:

Primary Outcome Measures:
  • postoperative compensatory hyperhidrosis [ Time Frame: 2008-2010 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • improvement of planter sweating assessment of overdry hands early postoperative complication ( pneumothorax,,,,,) recurrance [ Time Frame: 2008-2010 ] [ Designated as safety issue: No ]

    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.



Enrollment: 136
Study Start Date: February 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: t3 sympathicotomy
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.
Procedure: t3 sympathicotomy
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.
Other Name: sympathectomy
Procedure: t4 symapthicotomy
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.
Other Name: sympathectomy
Active Comparator: t4 sypathicotomy
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.
Procedure: t4 symapthicotomy
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.
Other Name: sympathectomy

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.

  Eligibility

Ages Eligible for Study:   15 Years to 38 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with primary palmar hyperhidrosis

Exclusion Criteria:

  • Patients with pleural adhesion
  • Bleeding diathesis
  • Local infection
  • Patients with certain anatomic anomalies
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01295853

Locations
Egypt
Mansoura University Hospital
Mansoura, Egypt, 35111
Sponsors and Collaborators
Mansoura University
Investigators
Principal Investigator: ahmed negm, md mansoura university hospital
  More Information

Publications:
1. 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;20:1749. 2. Moya J, Ramos R, Morera R, et al. Thoracic sympathicolysis for primary hyperhidrosis: A review of 918 procedures. Surg Endosc 2006;20:598.

Responsible Party: dr. ahmed negm, manoura university hospial
ClinicalTrials.gov Identifier: NCT01295853     History of Changes
Other Study ID Numbers: AMRO2345
Study First Received: February 14, 2011
Last Updated: February 14, 2011
Health Authority: Egypt: Ministry of Health and Population

Additional relevant MeSH terms:
Recurrence
Hyperhidrosis
Disease Attributes
Pathologic Processes
Sweat Gland Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014