Clinical trial NCT01295853: T3 Versus T4 Sympathicotomy for Treatment of Primary Palmar Hyperhidrosis
Official title: T3 Versus T4 Sympathicotomy for Treatment of Primary Palmar Hyperhidrosis: a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Compensatory Hyperhidrosis
Recurrence
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2011-02-15
Enrollment: 136
Sex: ALL
Minimum age (years): 15
Maximum age (years): 38
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* Patients with primary palmar hyperhidrosis

Exclusion Criteria:

* Patients with pleural adhesion
* Bleeding diathesis
* Local infection
* Patients with certain anatomic anomalies

Primary outcomes:
measure: postoperative compensatory hyperhidrosis
timeFrame: 2008-2010
Secondary outcomes:
measure: improvement of planter sweating assessment of overdry hands early postoperative complication ( pneumothorax,,,,,) recurrance
timeFrame: 2008-2010
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospital
Study officials:
affiliation: Mansoura University Hospital
name: ahmed negm, md
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.