Transthoracoscopic Sympathectomy T-3 and T-4 in moderate palmar Hyperhidrosis .

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Transtoracoscopic Sympathectomy T-3 and T-4 in moderate palmar Hyperhidrosis .

Secondary indentifying numbers:

cncma005

Issuing authority of the secondary identifying numbers:

Minimal Access Surgery National Centre

Source(s) of monetary or material support:

Ministry of Public Health (MINSAP)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Only approved by Ethics Committees

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Jose Manuel Hernández Gutiérrez. General Surgery MD.

Last name:

Not entered

Affiliation:

Not entered

Postal address:

Not entered

City:

Not entered

Country:

Not entered

Zip Code:

Not entered

Email address:

email@not.entered [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Research ethics committees:

Ethic Committee of the Minimal Access Surgery National Centre, June 8th, 2006. (Centralized commitete for the trial)

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

27/10/2006

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Palmar Hyperhidrosis

Intervention(s):

Study group (Surgery): Section of the dorsal sympathetic nerve at T3-T4 level, in each hemithorax . It is performed, using only one port, in axillary region, doing minimum access techniques. It is not necessary chest drains or antibiotics. Patients are treated in ambulatory regimen. Control group (Conventional treatment): Medical treatment for 1 month compound by: 1- Atropine (5 mg) 1 tablet by oral route every 8 h. 2- Topic solutions of Aluminum Acetate 8 %, every day, during 1 hour. 3- Homeopathic therapy 10 drops daily by sublingual route 4- Psychological therapy 3 times per week

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

1. Palmar sudation, (was eliminated, improved, was unchanged or became worse): at the end of treatment, 6 months and 12 months after treatment

Key secondary outcomes:

1- Physical limitation: (appearance or not from compensatory sweating, thermal disregulation or Claude-Bernard-Horner syndrome as adverse events in mayor o minor degree (no, slight, moderate, severe). Measurement time: at the end of the treatment, immediately, 6 month and 12 months after treatment. 2- Psychological limitation (no, slight, moderate, severe) Measurement time: at the end of the treatment, immediately, 6 month and 12 months after treatment. 3- Complications: (Neumothorax, Hemothorax, Loco-regional sepsis and persistent pain). Measurement time: at the end of the treatment, immediately, 6 month and 12 months after treatment. 4- Cost/utility. Measurement time: 1 year after treatment. 5- Psychological test (SRDARE, Prueba de Zung y Conie). Measurement time: Previus and postreatment for each group.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

16 years

Maximum age:

45 years

Inclusion criteria:

- Grade II or moderate Hiperhidrosis.

Exclusion criteria:

- Grades I or III. - Associate illnesses that impede the application of some of the - proposed interventions - Patient does not acept participate in this investigation ( patient recive all information concerning the desease, treatment,and the investigation and after that, they do not acept). - Less than 16 years old or more than 45 años.

Type of population:

Children and Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

2-3

Target sample size:

100

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

José

Middle Name:

Manuel

Last Name:

Hernández Gutiérrez

Affiliation:

Minimal Access Surgery National Centre

Postal Address:

Parraga 215 Street. Vibora. 10 de Octubre.

City:

Havana City

Country:

Cuba

Zip Code:

10700

Telephone:

(537)649 5333

Email :

jose@cce.sld.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

José

Middle Name:

Manuel

Last Name:

Hernández Gutiérrez

Affiliation:

Minimal Access Surgery National Centre

Postal Address:

Parraga 215 Street. Vibora. 10 de Octubre.

City:

Havana City

Country:

Cuba

Zip Code:

10700

Telephone:

(537)6495333

Email :

jose@cce.sld.cu [2]

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000154

Date of Registration in Primary Registry:

2013-05-24

Record Verification Date:

2013-05-04

Next update date:

2014-05-04

Link to the spanish version:

Click here [3]