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IRCT20120726010405N4 IRCT 2018-02-26 Vice chancellor for research,Mazandaran University of Medical Science Comparison of two open surgical procedures with release and without release of antebrachial fascia in patients with bilateral carpal tunnel syndrome Comparison of two open surgical procedures with release and without release of antebrachial fascia in patients with bilateral carpal tunnel syndrome 2016-09-22 anticipated 38 Complete https://irct.ir/trial/10902 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, simple randomization method was used. The participants were classified into two groups by computer and the type of operation was placed in a sealed envelope and and the surgeon performed the procedure according to it, but the surgeon Did not know about the type of operation before it, Blinding description: In this study,Patients before surgery and outcome evaluationer did not know about type of surgery. 3 carpal tunnel syndrome. Intervention 1: Intervention group: The release of the carpal tunnel with the release of the anti-brachial fascia, in which a 2 cm incision in the proximal palmar on the transverse ligament of the wrist will be performed, starting with the Kaplan's cardinal line. After the incision of skin, the subcutaneous tissue is cut with a Surgical Blade number 15 and the two edges of the cut are fixed with the retractor. The palmar facia will be opened and the wrist ligation will detected. The transverse ligament will accessed with a Surgical Blade No. 15 in order to provide access to the carpal tunnel and the median nerve is also detected. The transverse ligament will be opened to the distal part by scissors , and the anti-brachial fascia will be released as blunt to the proximal. Incision site will be folded by 0.4 Nylon thread and pressure bandage will be applied to it. Intervention 2: Control group:The release of the carpal tunnel without the release of the anti-brachial fascia, in which a 2 cm incision in the proximal palmar on the transverse ligament of the wrist will be performed, starting with the Kaplan's cardinal line. After the incision of skin, the subcutaneous tissue is cut with a Surgical Blade number 15 and the two edges of the cut are fixed with the retractor. The palmar facia will be opened and the wrist ligation will detected. The transverse ligament will accessed with a Surgical Blade No. 15 in order to provide access to the carpal tunnel and the median nerve is also detected. The transverse ligament will be opened to the distal part by scissors. Incision site will be folded by 0.4 Nylon thread and pressure bandage will be applied to it. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Dr seyed Mehran Razavipour
Mazandaran University of Medical Sciences, First of Vali Asr HWY., Joibar Junction, Emam Sq., Sari
Sari Iran (Islamic Republic of) 4815733971 +1 133377169 m.razavipour@mazums.ac.ir Mazandaran University of Medical Sciences scientific Dr seyed Mehran Razavipour
Mazandaran University of Medical Sciences, First of Vali Asr HWY., Joibar Junction, Emam Sq., Sari
Sari Iran (Islamic Republic of) 4815733971 +98 11 3337 7169 m.razavipour@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) sensory loss or numbness in the median nerve distribution positive Tinel sign positive Phalen’s test moderate or severe CTS on electrophysiological testing no response, or relapse following conservative treatment for a minimum 3 months 18 years no limit Both history of carpal tunnel surgery inflammatory arthropathy or peripheral neuropathy spine, shoulder, or elbow pathology history of hand trauma onset of CTS during pregnancy recurrent CTS age less than 18 years G56.0 Carpal tunnel syndrome Treatment - Surgery Treatment - Surgery Intervention group: The release of the carpal tunnel with the release of the anti-brachial fascia, in which a 2 cm incision in the proximal palmar on the transverse ligament of the wrist will be performed, starting with the Kaplan's cardinal line. After the incision of skin, the subcutaneous tissue is cut with a Surgical Blade number 15 and the two edges of the cut are fixed with the retractor. The palmar facia will be opened and the wrist ligation will detected. The transverse ligament will accessed with a Surgical Blade No. 15 in order to provide access to the carpal tunnel and the median nerve is also detected. The transverse ligament will be opened to the distal part by scissors , and the anti-brachial fascia will be released as blunt to the proximal. Incision site will be folded by 0.4 Nylon thread and pressure bandage will be applied to it. Control group:The release of the carpal tunnel without the release of the anti-brachial fascia, in which a 2 cm incision in the proximal palmar on the transverse ligament of the wrist will be performed, starting with the Kaplan's cardinal line. After the incision of skin, the subcutaneous tissue is cut with a Surgical Blade number 15 and the two edges of the cut are fixed with the retractor. The palmar facia will be opened and the wrist ligation will detected. The transverse ligament will accessed with a Surgical Blade No. 15 in order to provide access to the carpal tunnel and the median nerve is also detected. The transverse ligament will be opened to the distal part by scissors. Incision site will be folded by 0.4 Nylon thread and pressure bandage will be applied to it. Boston carpal tunnel (BCT) score. Timepoint: Before surgery,1,3,6 after surgery. Method of measurement: The severity scale-Functional status scale-Boston carpal tunnel (BCT). Patient's satisfaction. Timepoint: After surgery. Method of measurement: scale visual analog scale. Vice chancellor for research,Mazandaran University of Medical Science Approved 2016-10-17 Ethics Committee of Mazandaran University of Medical Science Deputy of Research and Technology of Mazandaran University of Medical Sciences,Moalem Sq., Moalem St., Sari Sari Mazandaran Iran (Islamic Republic of)