Back to resultsCarpal Tunnel Release Through Mini Transverse Approach (CTRMTA)
Primary Purpose
Carpal Tunnel Syndrome, Carpal Tunnel Release, Carpal Tunnel Surgery
Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Carpal tunnel release through Mini Transverse Approach
Sponsored by
About this trial
This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring CTS, Carpal tunnel syndrome, Carpal tunnel release, Mini incision of carpal tunnel release, Cosmetic surgery of carpal tunnel syndrome, endoscopic carpal tunnel surgery, Carpal Tunnel Release Through Mini Transverse Approach, Dr. Sayed Issa's Approach, CTRMTA, OCTR, ECTR, Open Carpal Tunnel Release, Endoscopic Carpal Tunnel Release, Syria, Cosmetic, Safety, Rehabilitation,, Complications, Surgery, Satisfaction
Eligibility Criteria
Inclusion Criteria:
- Patients presented with Carpal Tunnel Syndrome refractory to conservative treatment
- Participant cooperation sufficient to operate under local anesthesia
Exclusion Criteria:
- Un controlled diabetes mellitus type 1 and 2
- Patients with non controlled Vascular hypertension
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
- Patients with history of Carpal Tunnel release surgery failure
Sites / Locations
- Dr. Sayed Issa's Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Issa1
Arm Description
After local anesthesia, through transverse approach on the middle of dorsal wrist crease the incision is made for 1.5 cm length, then the subcutaneous fat is dissected, soon we see the the palmaris longus tendon or its connection with the carpal ligament , take the ulnar side of the palmaris longus tendon and cut the carpal ligament axillary by scalpel, not going deep with the scalpel to avoid medial nerve injury, soon we see the nerve, we use the scissors to cut the proximal part then the distal part of the carpal ligament by enclosing it between the blades of the scissors, now the full released carpal tunnel most be observed, and one stitch is enough, in this operation most be an assistant exist.
Outcomes
Primary Outcome Measures
Proportion of patients with post surgical trauma
Secondary Outcome Measures
Duration of rehabilitation period
Proportion of patients with cosmetic scar
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02766114
Brief Title
Carpal Tunnel Release Through Mini Transverse Approach
Acronym
CTRMTA
Official Title
Carpal Tunnel Release Through Mini Transverse Approach
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Issa, Abdulhamid Sayed, M.D.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Carpal tunnel release through dorsal wrist crease Mini Transverse incision, about 1.5 cm length.
Detailed Description
Carpal tunnel release through a small approach on the distal wrist crease, it is about 1.5 cm, the benefits of this technique is less surgical traumatic and more tender, it takes less time for rehabilitation, so the patient can work next day of operation, and it has very cosmetic and gentle scar in results and outcome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome, Carpal Tunnel Release, Carpal Tunnel Surgery, Carpal Tunnel Transverse Approach, CTS
Keywords
CTS, Carpal tunnel syndrome, Carpal tunnel release, Mini incision of carpal tunnel release, Cosmetic surgery of carpal tunnel syndrome, endoscopic carpal tunnel surgery, Carpal Tunnel Release Through Mini Transverse Approach, Dr. Sayed Issa's Approach, CTRMTA, OCTR, ECTR, Open Carpal Tunnel Release, Endoscopic Carpal Tunnel Release, Syria, Cosmetic, Safety, Rehabilitation,, Complications, Surgery, Satisfaction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Issa1
Arm Type
Experimental
Arm Description
After local anesthesia, through transverse approach on the middle of dorsal wrist crease the incision is made for 1.5 cm length, then the subcutaneous fat is dissected, soon we see the the palmaris longus tendon or its connection with the carpal ligament , take the ulnar side of the palmaris longus tendon and cut the carpal ligament axillary by scalpel, not going deep with the scalpel to avoid medial nerve injury, soon we see the nerve, we use the scissors to cut the proximal part then the distal part of the carpal ligament by enclosing it between the blades of the scissors, now the full released carpal tunnel most be observed, and one stitch is enough, in this operation most be an assistant exist.
Intervention Type
Procedure
Intervention Name(s)
Carpal tunnel release through Mini Transverse Approach
Intervention Description
Carpal tunnel release through a transverse cosmetic small incision over the distal wrist crease.
Primary Outcome Measure Information:
Title
Proportion of patients with post surgical trauma
Time Frame
Up to eight weeks
Secondary Outcome Measure Information:
Title
Duration of rehabilitation period
Time Frame
Up to three weeks
Title
Proportion of patients with cosmetic scar
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients presented with Carpal Tunnel Syndrome refractory to conservative treatment
Participant cooperation sufficient to operate under local anesthesia
Exclusion Criteria:
Un controlled diabetes mellitus type 1 and 2
Patients with non controlled Vascular hypertension
Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
Patients with history of Carpal Tunnel release surgery failure
Facility Information:
Facility Name
Dr. Sayed Issa's Clinic
City
Aleppo
Country
Syrian Arab Republic
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Carpal Tunnel Release Through Mini Transverse Approach
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