Comparing a Modified Mini-incision Approach Versus the Conventional Approach for Carpal Tunnel Release

NCT06114823 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2023-11-02

No results posted yet for this study

Summary

Carpal tunnel syndrome (CTS) is the commonest nerve compression syndrome in the upper limbs, and carpal tunnel decompression is one of the most prevalent upper limb surgical interventions. Surgeries for CTS may be more effective compared to conservative measures in reducing symptoms and improving hand function, particularly in patients with severe CTS.

The etiology of CTS is multifactorial and includes occupational and personal factors. Physical workload factors play an important role in CTS but the role of some personal factors is less clear. Obesity is a well-documented risk factor for CTS. Hypothyroidism, diabetes mellitus, rheumatoid arthritis and osteoarthritis are possible risk factors for CTS. Finally, the role of smoking in CTS is uncertain.

Traditional approach makes use of a longitudinal skin incision from the palm toward the wrist and across the transverse carpal ligament. Though this approach offers excellent visualization, reliable release of the full retinaculum, and ability to identify anatomic variations, it is associated with some intractable complications, including wound pain, scar tenderness, flexor tendon entrapment and thenar as well as hypothenar (pillar) pain, which are difficult to recovery.

The attempt to perform CTR without extra complications leads to the development of different techniques and several mini-incision approaches.

These techniques help to reduce incisional discomfort after surgery, but it can lead to frequent incidence of blood vessel injury or incomplete release. The mini-incision approaches have the advantage of leaving a smaller scar, less scar pain, and lower grade of pillar pain. Though several methods have been proposed, there were still some disadvantages in them. Though CTR can be safely accomplished by them, incomplete release still occurred in several cases for some reasons.

After intensive research in the current literature, there is a paucity of studies evaluating the efficacy and safety of mini-incision approaches in achieving CTR in Egyptian patients. That is why we conducted the present study to present our experience with the modified mini-incision technique and compare its outcomes to the conventional open approach.

Conditions

  • Carpal Tunnel Syndrome
  • Incision

Interventions

PROCEDURE

carpal tunnel release mini-incision

Patients were subjected to a longitudinal mini-incision started just above the proximal flexor wrist crease and then extended for 1.5 - 2 cm in a proximal direction

PROCEDURE

carpal tunnel release conventional incision

Patients were subjected a longitudinal incision which was created between the thenar and hypothenar eminences along the longitudinal axis of the ring finger. Then, it was extended to the proximal flexor wrist crease.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • mohamed mahmoud, MD · Mansoura faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2022-08-31
Completion
2022-11-30

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06114823 on ClinicalTrials.gov