Protocol summary

Summary
Introduction: Despite profound effects on quality of hyperhidrosis in patients' life in many aspects, it is important to evaluate methods of therapies. This study is aimed to evaluate thoracoscopic sympathectomy technique in patients with hyperhidrosis. Materials and Methods: 20 patients more than 5 years old with bilateral hyperhidrosis in the armpit and hand enrolled in this cross-sectional study after obtaining written informed consent, patients with hyperthyroidism; hypopituitarism; metabolic diseases; pregnancy; carcinoid syndrome; acromegaly; neurologic diseases; malignancy; febrile diseases; cardiovascular shock; heart failure; respiratory failure; alcohol poisoning; signs of hanging down or depression; neuroplastic diseases; use of drugs and tuberculosis are excluded. Patients who are under general anesthesia are operated for a bilateral surgical operation. Three five mm ports were entered into the pleural space, one in fourth- fifth place between a rib in intercostal midaxillary in order to enter the camera and the second and third in the forth space- Infra- mammary fold of the fifth midclavicular between a rib in the posterior axillary line. T2 and T4 will be interrupted. The lungs T3 will be extended after hemostasis and before removing the camera, and then the camera will be out. The patient will be discharged two days later in the case of no surgical outcomes such as pain; bleeding from the costal vein; pleural effusion and short- term pulmonary diseases. Demographic information and association symptoms such as fever and night sweets; duration of surgery; place of affected; family history; length of stay; type of disorder and measure of sweating after surgery are compiled by a check list. All patients will be investigated up to 6 months after surgery for early complications.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014092419255N3
Registration date: 2014-10-28, 1393/08/06
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-10-28, 1393/08/06
Registrant information
Name
Novin Nikbakhsh
Name of organization / entity
Babol University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 11 3225 6285
Email address
n.nicbakhsh@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
The Deputy of Research and Technology of Babol University of Medical Sciences
Expected recruitment start date
2014-06-04, 1393/03/14
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Thoracoscopic sympathectomy assessed in patients with Hyperhidrosis training centers
Public title
Thoracoscopic sympathectomy assessed in patients with Hyperhidrosis training centers:A clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Patients who are five years and older; with bilateral hyperhidrosis in the armpits and hands; and written informed consent; Exclusion criteria: Patients with hyperthyroidism; hypopituitarism; metabolic diseases (thyrotoxicosis; Diabetes mellitus; hypoglycemia; gout; pheochromocytoma; menopause); pregnancy; carcinoid syndrome; acromegaly; neurologic diseases (Parkinson’s disease; spinal cord injuries; cerebral vascular damage); malignancies (myeloproliferative disorders; Hodgkin's disease); febrile diseases; cardiovascular shock; heart failure; respiratory failure; alcohol poisoning (chronic alcoholism and drug abuse); signs of hanging down or depression; neuroplastic diseases; use of drugs and tuberculosis
Age
From 5 years old to 100 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Babol University of Medical Sciences, University Square, Babol, Mazandaran
City
Babol
Postal code
Approval date
2014-06-03, 1393/03/13
Ethics committee reference number
4232

Health conditions studied

1

Description of health condition studied
Hyperhidrosis
ICD-10 code
R61.0
ICD-10 code description
Localized hyperhidrosis

Primary outcomes

1

Description
The palmar and axillary hyperhidrosis
Timepoint
Before and After Surgery
Method of measurement
Clinical

Secondary outcomes

1

Description
Compensatory sweating in other areas of the body
Timepoint
Measured monthly, 6 months later
Method of measurement
Clinical

Intervention groups

1

Description
Sympathectomy sympathetic ganglia
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Fatemeh Erfani
Street address
Shahid beheshti Hospital, Shahid Keshvari Square, Babol
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The Deputy of Research and Technology of Babol University of Medical Sciences
Full name of responsible person
Aliakbar Moghadamnia
Street address
Babol University of Medical Sciences, University Square, Babol
City
Babol
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Deputy of Research and Technology of Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact

Person responsible for scientific inquiries

Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Novin Nikbakhsh
Position
Associate Professor, Surgery
Other areas of specialty/work
Street address
Shahid Beheshti Hospital, Shahid Keshvari Square, Babol
City
Babol
Postal code
Phone
+98 11 3225 6285
Fax
Email
novinsu@hotmail.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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