Comparison of satisfaction, performance and pain in patients undergoing carpal tunnel syndrome surgery with skin repair using two simple and subcuticular methods
This study's aim is to compare satisfaction, performance and pain in patients undergoing carpal tunnel syndrome surgery with skin repair using two simple and subcuticular methods. The practical aim is to achieve a suitable suturing method with minimum scar and pain and maximum satisfaction.
Design
Two arm parallel group interventional clinical trial
Settings and conduct
Patients who have been diagnosed with bilateral CTS are examined by an orthopedic surgeon at the Besat Hospital. After prep and drape in sterile conditions and under proper anesthesia with tourniquet control with open technique MINI-PALM carpal tunnel release is performed. the skin of one hand is repaired with a single interrupted method, and the other hand is repaired with a continuous subcuticular method, both using Non-absorbable 3-0 nylon.
Participants/Inclusion and exclusion criteria
The participants include all patients over 18 years of age who referred to Besat Hospital in Hamedan with the diagnosis of severe or moderate bilateral CTS. The conditions of non-entry include: the severity of CTS is different in both hands according to clinical criteria and NCV-EMG; The onset of symptoms for each hand is more than 10 months; CTS has developed in the context of inflammatory diseases; history of psychiatric diseases; history of skin diseases; having diseases affecting blood vessels and peripheral nerves.
Intervention groups
Surgery is performed simultaneously on both hands in all patients. One hand is repaired with single interrupted method, and the other hand is repaired with continous subcuticular method. an orthopedic surgeon visits patients In weeks 2, 6, and 12, and BCTQ, POSAS, and VAS questionnaires are filled for each hand separately. The sutures are removed in the second week for both hands.
Main outcome variables
Satisfaction; performance; pain score; scar score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231121060126N1
Registration date:2023-11-29, 1402/09/08
Registration timing:registered_while_recruiting
Last update:2023-11-29, 1402/09/08
Update count:0
Registration date
2023-11-29, 1402/09/08
Registrant information
Name
Asrin Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3461 3439
Email address
asrin1997@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-29, 1402/09/08
Expected recruitment end date
2023-12-09, 1402/09/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of satisfaction, performance and pain in patients undergoing carpal tunnel syndrome surgery with skin repair using two simple and subcuticular methods
Public title
Comparison of two skin repair methods in carpal tunnel syndrome surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients over 18 years old with a diagnosis of severe or moderate bilateral Carpal Tunnel Syndrome
Exclusion criteria:
The severity of carpal tunnel syndrome is different bilaterally according to clinical criteria and EMG-NCV
The onset of symptoms for each hand is more than 10 months
Carpal tunnel syndrome is caused by inflammatory diseases such as rheumatoid arthritis
History of psychiatric diseases such as depression
History of skin diseases
The existence of diseases involving blood vessels and peripheral nerves such as diabetes
Age less than 18 years
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
42
More than 1 sample in each individual
Number of samples in each individual:
2
Patient's right and left hand
Randomization (investigator's opinion)
N/A
Randomization description
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 Hamedan University of Medical Sciences
Street address
Shahid Fahmideh Blvd., Hamedan University of Medical Sciences, fourth floor
City
Hamedan
Province
Hamadan
Postal code
6517838678
Approval date
2023-11-29, 1402/09/08
Ethics committee reference number
IR.UMSHA.REC.1402.556
Health conditions studied
1
Description of health condition studied
Carpal Tunnel Syndrome
ICD-10 code
G56
ICD-10 code description
Mononeuropathies of upper limb
Primary outcomes
1
Description
Satisfaction and performance score in BCTQ questionnaire
Timepoint
Filling the BCTQ questionnaire in 2, 6, 12 weeks after Carpal Tunnel Reslease Surgery
Method of measurement
BCTQ questionnaire
2
Description
Scar score in POSAS questionnaire
Timepoint
Filling the POSAS questionnaire in 2, 6, 12 weeks after Carpal Tunnel Reslease Surgery
Method of measurement
POSAS questionnaire
3
Description
Pain score in VAS questionnaire
Timepoint
Filling the VAS questionnaire in 2, 6, 12 weeks after Carpal Tunnel Reslease Surgery
Method of measurement
VAS questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Repair of patients' right hand surgical incision by simple suture method with non-absorbable 3-0 nylon
Category
Treatment - Surgery
2
Description
Intervention group 2: Repair of patients' left hand surgical incision by subcuticular suture method with non-absorbable 3-0 nylon
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital in Hamedan
Full name of responsible person
Sepehr Shirouei
Street address
Besat hospital, Shahid Beheshti Blvd.
City
Hamedan
Province
Hamadan
Postal code
32651515
Phone
+98 81 3264 0020
Email
asrin1997@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokouhi
Street address
Shahid Fahmideh Blvd., Hamedan University of Medical Sciences, fourth floor
City
Hamedan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3131 4058
Email
asrin1997@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?