Clinical Trials Directory

Trials / Completed

CompletedNCT03062722

Efficacy of Keyhole Approach to Carpal Tunnel Syndrome Under Ambulatory Strategy

Efficacy of Keyhole Approach to Carpal Tunnel Syndrome Under Ambulatory

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
55 (actual)
Sponsor
Ivan Segura Duran · Academic / Other
Sex
All
Age
30 Years – 60 Years
Healthy volunteers
Not accepted

Summary

Prospective controlled clinical trial in which a minimally invasive microsurgical approach was used following the keyhole principle in 55 patients and 65 hands under local anesthesia and ambulatory strategy. All patients included in the study had an average of 3 months disease course and were considered refractory to conservative treatment. Patients were evaluated with stringent inclusion criteria with the Levine severity and functional status scale with a 2 year follow-up. Descriptive outcomes on the efficiency of this procedure are reported.

Detailed description

Prospective clinical study to analyze 55 patients with carpal tunnel syndrome treated with open minimally invasive approach in 65 hands, using local anesthesia without tourniquet and in an ambulatory setting.

Conditions

Interventions

TypeNameDescription
PROCEDUREkeyhole approachThe surgical procedure was a direct microsurgical approach with a 1.5 cm incision in the thenar sulcus, under local anesthesia (3cc, 2% lidocaine) administered with an insulin needle. The keyhole approach applied to this anatomical region is based on a 1.5 cm skin incision from where the 0.5 cm dissection is completed in the subcutaneous plane in the side borders and 1cm in the distal and proximal borders. Thus, the subcutaneous phase of the dissection is completed with separation of the carpal ligament and resection of its borders. Once the transverse fibers are open, the perineural micro adhesions of the median nerve are resected and 3mm of the free borders of the carpal fibers found on the nerve are removed to avoid fibrosis. The wound is checked for hemostasis and closed in apposition with Vicryl 3-0 and a single subdermal 3-0 Nylon stitch.

Timeline

Start date
2015-01-01
Primary completion
2015-12-01
Completion
2016-07-01
First posted
2017-02-23
Last updated
2017-02-23

Source: ClinicalTrials.gov record NCT03062722. Inclusion in this directory is not an endorsement.