Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06114823 |
| Other study ID # |
2345 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
November 1, 2021 |
| Est. completion date |
November 30, 2022 |
Study information
| Verified date |
October 2023 |
| Source |
Mansoura University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
All selected cases with primary CTS will be submitted to:
I) Preoperative evaluation:
A- Careful history taking: Brief history based on the characteristics of pain, sensory
disturbances including numbness, tingling, and/or weakness involving the median nerve
distribution. Patients were additionally inquired about their functional status, normal
activities, ability to work, family history of diabetes and the use of medications.
B- The visual analogue scale (VAS) (0= no pain to 10= worst possible pain), will be used to
assess the severity of diabetic neuropathic pain.
C- Neurosensory examination mainly included percussion over a distribution of the affected
peripheral nerve (Tinel sign) and two-point discrimination (2-PD) using the Disk-Criminator.
D- Nerve conduction velocity (NCV).
II) Surgical Technique:
All patients are positioned on the operating table in supine position and anesthetized with
local anaesthesia.
A) For the conventional approach: a palmar longitudinal incision began at the axis of the
ring finger, passed between the thenar and hypothenar eminences, and continued proximally to
the proximal flexor crease of the wrist. After exposing the underlying transverse carpal
ligament, its ulnar side was cut longitudinally. The median nerve was identified and
protected, and then the wound was closed in routine manner.
B) For the new mini-incision approach: a special metal guide with a groove at the center is
used. The incision is started above the proximal flexor crease of the wrist and is advanced
proximally for 1.5-2.0 cm. After opening the superficial fascia, blunt dissection with a
mosquito clamp is performed till the median nerve appears and the guide is inserted into the
carpal tunnel, then a scissor is inserted along the groove in the guide and the transverse
carpal ligament is cut proximally and distally.
III) Postoperative follow up:
The follow-up was conducted mainly on an outpatient basis comparing the postoperative outcome
in both groups as regard improvement of symptoms, postoperative complications, scar effect
and recurrence of symptoms. Patients will be followed up at 2 weeks, 1 month, 3 months, and 6
months post decompression.
