Evaluation of prognosis improvement in patients undergoing carpal tunnel release surgery after using drain.
Design
Clinical trials with control group, randomized with parallel groups
Settings and conduct
This study is being conducted at Shahid Doctor Rahnamoon Hospital.
Patients with carpal tunnel syndrome are enrolled Based on the criteria for entering the study and are randomly assigned to two groups of 31 patients.
Blinding is not done. Patients in each of the 2 groups after the carpal tunnel release surgery are evaluated through examination, visual analogue scale and pinch strength.
Participants/Inclusion and exclusion criteria
Patients referred to the orthopedic clinic of Shahid Doctor Rahnemoon Hospital who have severe carpal tunnel syndrome confirmed by clinical examination and nerve and muscle or with Moderate carpal tunnel syndrome, who did not respond to conservative treatment, enter the study with informed consent. Patients who simultaneously undergo surgery in addition to releasing the carpal tunnel, Patients with intraoperative Iatrogenic vascular injury and
Patients with a history of anticoagulation therapy Or coagulation disorders are excluded.
Intervention groups
Intervention group: For patients in this group after the release of the carpal tunnel Drainage will be used. Control group: Patients in this group after the operation will not be used of the drain.
Main outcome variables
Bleeding and hematoma; Pain; Pinch strength
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161225031559N3
Registration date:2018-10-17, 1397/07/25
Registration timing:registered_while_recruiting
Last update:2018-10-17, 1397/07/25
Update count:0
Registration date
2018-10-17, 1397/07/25
Registrant information
Name
Seyed Hossein Saeed-Banadaky
Name of organization / entity
Shahid Sadoughi Medical University
Country
Iran (Islamic Republic of)
Phone
+98 35 3626 0001
Email address
saeed@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of drain application on outcome of open carpal tunnel release
Public title
The effect of drain application on outcome of surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with severe carpal tunnel syndrome confirmed by clinical examination and electrodiagnostic testing.
Patients with Moderate carpal tunnel syndrome who did not respond to conservative treatment
Informed consent
Exclusion criteria:
Patients who simultaneously undergo surgery in addition to releasing the carpal tunnel.
Patients with intraoperative Iatrogenic vascular injury
Patients with a history of anticoagulation therapy Or coagulation disorders.
Age
From 25 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
In this study through simple random method with the table of random numbers patients assigned to two groups
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yazd Shahid Sadoughi University of Medical Sciences
Street address
Yazd Shahid Sadoughi university of medical sciences, Bahonar Sq, Yazd.
City
Yazd
Province
Yazd
Postal code
8916978477
Approval date
2018-04-29, 1397/02/09
Ethics committee reference number
IR.SSU.MEDICINE.REC.1397.090
Health conditions studied
1
Description of health condition studied
Carpal Tunnel Syndrome
ICD-10 code
G56.0
ICD-10 code description
Carpal tunnel syndrome
Primary outcomes
1
Description
The extent of bleeding and hematoma
Timepoint
2 days after surgery
Method of measurement
The extent of bleeding on the dressing gauze and Expert examination
Secondary outcomes
1
Description
Postoperative pain
Timepoint
2, 4 and 6 weeks after surgery
Method of measurement
The visual analogue scale
2
Description
Pinch strength
Timepoint
2, 4, 6 months after surgery
Method of measurement
Pinch meter
Intervention groups
1
Description
Intervention group: For patients in this group after the release of the carpal tunnel Drain will be used.
Category
Treatment - Devices
2
Description
Control group: Patients in this group after the operation will not be used of the drain.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Doctor Rahnemoon Hospital
Full name of responsible person
Maziar Malekzadeh
Street address
Shahid Doctor Rahnemoon Hospital, Farrokhi Street, Yazd.
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3626 0000
Email
maziar.malekzadeh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Masoud Mirzaei
Street address
Shahid Sadoughi University of Medical Sciences, Bahonar Sq,Yazd
City
Yazd
Province
Yazd
Postal code
8916978477
Phone
+98 35 3726 3733
Email
mmirzaei@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Maziar Malekzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Orthopedics
Street address
Department of Orthopedics, Shahid Doctor Rahnemoon Hospital, Farokhi St, Yazd
City
Yazd
Province
Yazd
Postal code
8913814396
Phone
+98 35 3626 0000
Email
maziar.malekzadeh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Seyed Hossein Saeed Banadaki
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Department of Orthopedics, Shahid Doctor Rahnemoon Hospital, Farokhi St, Yazd
City
Yazd
Province
Yazd
Postal code
8913814396
Phone
+98 35 3626 0000
Email
h.saeed.b@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Seyed Hossein Saeed Banadaki
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Department of Orthopedics, Shahid Doctor Rahnemoon Hospital, Farokhi St, Yazd
City
Yazd
Province
Yazd
Postal code
8913814396
Phone
+98 35 3626 0000
Email
h.saeed.b@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available