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Carpal Tunnel Release Through Mini Transverse Approach (CTRMTA)

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ClinicalTrials.gov Identifier: NCT02766114
Recruitment Status : Completed
First Posted : May 9, 2016
Last Update Posted : May 9, 2016
Sponsor:
Information provided by (Responsible Party):
Issa, Abdulhamid Sayed, M.D.

Brief Summary:
Carpal tunnel release through dorsal wrist crease Mini Transverse incision, about 1.5 cm length.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Carpal Tunnel Release Carpal Tunnel Surgery Carpal Tunnel Transverse Approach CTS Procedure: Carpal tunnel release through Mini Transverse Approach Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Carpal Tunnel Release Through Mini Transverse Approach
Study Start Date : February 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016


Arm Intervention/treatment
Experimental: Issa1
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.
Procedure: Carpal tunnel release through Mini Transverse Approach
Carpal tunnel release through a transverse cosmetic small incision over the distal wrist crease.




Primary Outcome Measures :
  1. Proportion of patients with post surgical trauma [ Time Frame: Up to eight weeks ]

Secondary Outcome Measures :
  1. Duration of rehabilitation period [ Time Frame: Up to three weeks ]
  2. Proportion of patients with cosmetic scar [ Time Frame: Up to 6 months ]


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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02766114


Locations
Syrian Arab Republic
Dr. Sayed Issa's Clinic
Aleppo, Syrian Arab Republic
Sponsors and Collaborators
Issa, Abdulhamid Sayed, M.D.

Responsible Party: Issa, Abdulhamid Sayed, M.D.
ClinicalTrials.gov Identifier: NCT02766114     History of Changes
Obsolete Identifiers: NCT02726165, NCT02766413
Other Study ID Numbers: Sayed Issa's Approach
First Posted: May 9, 2016    Key Record Dates
Last Update Posted: May 9, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Issa, Abdulhamid Sayed, M.D.:
CTRMTA
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
OCTR
ECTR
Open Carpal Tunnel Release
Endoscopic Carpal Tunnel Release
Syria
Cosmetic
Safety
Rehabilitation,
Complications
Surgery
Satisfaction

Additional relevant MeSH terms:
Syndrome
Carpal Tunnel Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries