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Comparison of endoscopic and open surgery of tendon transfer for radial nerve palsy

Protocol summary

Summary
This study compare, endoscopic and open surgery of tendon transfer in radial nerve palsy, and outcomes such as: tendon harvest time, rate of post surgical pain, length of hospitalization, amount of pain medication, patient satisfaction, amount of scar, length of scar, are measured. In this single blinded randomaized clinical trial ,patients with radial nerve palsy ten cases of tendon transfer in both endoscopic and open procedure done based random classification is balanced block randomization are done by the software.all procedures are performed by a single surgeon. At the end of surgery the person responsible for data collection related to study without having knowledge of the patient and surgical procedure ,collect informations .after completing the information ,this information will be analyzed with spss18statical software and it is considered significant if p-value less than ./05.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016102430462N1
Registration date: 2017-03-11, 1395/12/21
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-03-11, 1395/12/21
Registrant information
Name
Shahryar Sadeghi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 1583
Email address
akhondi.mr@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran University of Medical Sciences
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2017-03-20, 1395/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of endoscopic and open surgery of tendon transfer for radial nerve palsy
Public title
Comparing the tow type of tendon surgery in the treatment of hand paralysis
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: patients with an age range 15-60 years with traumatic radial nerve injury Exclusion criteria: patients with non traumatic radial nerve injury; patients who have other peripheral nerve injury; patients treated with corticosteroids
Age
From 15 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Postal code
1449614525
Approval date
2016-09-22, 1395/07/01
Ethics committee reference number
IR.IUMS.REC1395.9311256004

Health conditions studied

1

Description of health condition studied
Radial nerve palsy
ICD-10 code
S44.2,S54.
ICD-10 code description
Injury of radial nerve at arm level .injury of radial nerve at forearm level

Primary outcomes

1

Description
Tendons harvest time
Timepoint
During the intervention
Method of measurement
Minute

Secondary outcomes

1

Description
Rate of Surgical site scar
Timepoint
Six months after surgery
Method of measurement
Vancouver scar scale

2

Description
Length of surgical incision
Timepoint
During the intervention
Method of measurement
Centimeter

3

Description
The amount of pain after surgery
Timepoint
Up to 24 hours after surgery
Method of measurement
Visual analogue pain

4

Description
The level of patients satisfaction from extension of surgery
Timepoint
Six months after surgery
Method of measurement
Visual analog scale

5

Description
The amount of pain medication after surgery
Timepoint
Up to 24 hours after surgery
Method of measurement
Dose of drug

6

Description
Duration of hospitalization after surgery
Timepoint
At the time of hospital discharge
Method of measurement
Day

Intervention groups

1

Description
In the interventional group using endoscopic surgery ,using a minimum incision under the endoscopic magnification tendons are harvested
Category
Treatment - Surgery

2

Description
In the control group using conventional open surgery tendons are harvested
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Fatemeh Hospital
Full name of responsible person
Shahryar Sadeghi
Street address
Hazrat Fatemeh Hospital, street 23, Yousefabad, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputyof research of Medical University of Iran
Full name of responsible person
Ali Javad mosavi
Street address
Central Building of Iran University of Medical sciences, Hemmat Highway, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputyof research of Medical University of Iran
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
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shahryar Sadeghi
Position
Plastic surgery fellowship /assistant
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Postal code
1449614525
Phone
+98 21 8805 2191
Fax
+98 218852963
Email
shahryarsadeghi55@yahoo.com
Web page address
www.iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammadreza Akhondinasab
Position
Plastic surgeon/faculty member
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Postal code
1149614525
Phone
+98 21 8805 2191
Fax
+98 218852963
Email
Akhondi.mr@iums.ac.ir
Web page address
www.iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Shahryar Sadeghi
Position
Plastic surgery fellowship /assistant
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Hemmat Highway, Tehran
City
Tehran
Postal code
1149614525
Phone
+98 21 8805 2191
Fax
+98 218852963
Email
Web page address
www.iums.ac.ir

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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