We aimed to make a comparison between the outcomes of the open-CT release and mini-incision CT release in patients with CTS
Design
The protocol of this study was approved by Vice-Chancellor for Research and Technology of Shahid Beheshti University of Medical Sciences, Tehran, Iran. All consents were obtained by surgical residents and attending physicians. This non-randomized clinical trial was consisted of 75 patients with CTS to undergo CTS surgery.
Settings and conduct
The study took place in Shohadaye Tajrish hospital. In this study blinding technique was not applicable.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: numbness in the distribution of the median nerve, nocturnal paresthesias, weakness and atrophy of the thenar muscle, presence of a positive Tinel’s and/or Phalen’s sign on physical examination and electrodiagnostic findings of moderate to severe disease
Exclusion Criteria: other peripheral neuropathies
Intervention groups
Seventy five patients with CTS who were divided into two groups of 45 and 30 patients to undergo open-CT release or mini incision CT release, respectively. In open-CT release a skin incision is made extending from Kaplan’s cardinal line distally to beyond the wrist crease proximally. The transverse carpal ligament is reached through the elimination of the subcutaneous fatty tissue and palmar fascia. Then an incision is made to release the nerve. In mini-incision group 1-cm incision is marked in the palm, beginning at the intersection of Kaplan’s cardinal line and a line drawn along the radial border of the third web. The 1.5 cm second skin incision is made on a line between tendons and then after reaching to palmar fascia a tunnel is made under fascia and the fascia and carpal ligament is cut to release the nerve.
Main outcome variables
Pain, satisfaction, return to work, length of scar, paresthesia, grip and opposition strength
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191019045155N3
Registration date:2020-02-15, 1398/11/26
Registration timing:retrospective
Last update:2020-02-15, 1398/11/26
Update count:0
Registration date
2020-02-15, 1398/11/26
Registrant information
Name
Negin Yavari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8802 9600
Email address
negin.yavarii@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2015-09-06, 1394/06/15
Expected recruitment end date
2016-08-22, 1395/06/01
Actual recruitment start date
2015-09-16, 1394/06/25
Actual recruitment end date
2016-06-21, 1395/04/01
Trial completion date
2016-06-21, 1395/04/01
Scientific title
Comparing the Open Carpal Tunnel release with Mini Incision Carpal Tunnel Release in the Carpal Tunnel Syndrome (CTS)
Public title
Surgical Options of CTS
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Positive Tinel’s
Electrodiagnostic findings of moderate to severe CTS
Weakness and atrophy of the thenar muscle
Nocturnal paresthesia
Numbness
Positive Phalen’s sign
The patients were visited the day after operation and also after 5 months post-operation.
Method of measurement
by visiting the patients, examining and using VAS method to measure their pain
2
Description
Satisfaction
Timepoint
The patients were visited the day after operation and also after 5 months post-operation.
Method of measurement
by visiting the patients, examining and questioner
3
Description
Return to work
Timepoint
The patients were visited the day after operation and also after 5 months post-operation.
Method of measurement
by visiting the patients, examining and questioner
4
Description
Grip strength
Timepoint
The patients were visited the day after operation and also after 5 months post-operation.
Method of measurement
by visiting the patients, examining
5
Description
Opposition strength
Timepoint
The patients were visited the day after operation and also after 5 months post-operation.
Method of measurement
by visiting the patients, examining
6
Description
Length of scar
Timepoint
The patients were visited the day after operation and also after 5 months post-operation.
Method of measurement
by visiting the patients, examining
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: A skin incision is made extending from Kaplan’s cardinal line distally to beyond the wrist crease proximally. The transverse carpal ligament is reached through the elimination of the subcutaneous fatty tissue and palmar fascia. Then an incision is made to release the nerve.
Category
Treatment - Surgery
2
Description
Intervention group 2: 1-cm incision is marked in the palm, beginning at the intersection of Kaplan’s cardinal line and a line drawn along the radial border of the third web. The 1.5 cm second skin incision is made on a line between tendons and then after reaching to palmar fascia a tunnel is made under fascia and the fascia and carpal ligament is cut to release the nerve.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada-Tajrish hospital
Full name of responsible person
Jalaluddin Khoshnevis
Street address
Tajrish Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
Pr_shohada@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Seyed Ali Ziaei
Street address
Tajrish Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
pr_shohada@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Jalaluddin Khoshnevis
Position
Associate professor of surgery
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Tajrish Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
pr_shohada@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Jalaluddin Khoshnevis
Position
Associate professor of surgery
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Tajrish Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
pr_shohada@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Jalaluddin Khoshnevis
Position
Associate professor of surgery
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Tajrish Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 25719
Email
pr_shohada@sbmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All the data will be available under the name of supplementary.
When the data will become available and for how long
All the data will be available after the publication of the article forever
To whom data/document is available
Data will be available to everybody upon request
Under which criteria data/document could be used
Data could be used by other researchers for meta-analysis and systematic review
From where data/document is obtainable
Data will be available as a supplementary file to the published article
What processes are involved for a request to access data/document