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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

February 14, 2011
February 14, 2011
February 2008
September 2010   (final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
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.

Same as current
Not Provided
Not Provided
 
T3 Versus T4 Sympathicotomy for Treatment of Primary Palmar Hyperhidrosis
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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Compensatory Hyperhidrosis
  • Recurrence
  • 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: 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.
    Interventions:
    • Procedure: t3 sympathicotomy
    • Procedure: t4 symapthicotomy
  • 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.
    Intervention: Procedure: t4 symapthicotomy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
136
September 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with primary palmar hyperhidrosis

Exclusion Criteria:

  • Patients with pleural adhesion
  • Bleeding diathesis
  • Local infection
  • Patients with certain anatomic anomalies
Both
15 Years to 38 Years
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
NCT01295853
AMRO2345
Yes
dr. ahmed negm, manoura university hospial
Mansoura University
Not Provided
Principal Investigator: ahmed negm, md mansoura university hospital
Mansoura University
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP