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

NCT06114823 | Completed

• 1 other identifier: 2345
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• improvement in carpal tunnel syndrome associated pain

  According to visual analogue scale for pain which consists of 10 items , 0 for no pain and 10 for the maximum pain.

  6 months postoperative

Secondary Outcomes (4)

• pillar pain

  1,3&6 months postoperative

• recurrence of neuropathic symptoms

  it will be evaluated till 6 months postoperative

• operative time

  from start till the end of the operation

• scar effect

  from surgery till 3,6 months postoperative

Study Arms (2)

mini incision group

ACTIVE COMPARATOR

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 mini-incision; Procedure: carpal tunnel release conventional incision

conventional group

ACTIVE COMPARATOR

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.

Procedure: carpal tunnel release mini-incision; Procedure: carpal tunnel release conventional incision

Interventions

carpal tunnel release mini-incision PROCEDURE

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

conventional group; mini incision group

carpal tunnel release conventional incision PROCEDURE

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.

conventional group; mini incision group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with primary CTS attending Mansoura university hospitals with EMG-and NCS-proved median neuropathy at the wrist.
• Failed conservative treatment.
• Absence of any other hand pathology.
• Positive Tinel sign presented at the site of nerve entrapment (the carpal tunnel at the wrist for the median nerve).
• Signed informed consent.

You may not qualify if:

• Presence of proximal radiculopathy.
• Previous history of cervical spondylosis.
• Inflammatory joint disease and gout.
• Presence of combined nerve compression.
• Having a previous hand or upper extremity surgery.
• Patients with incomplete follow-up data were also excluded from this study.
• Psychiatric disease or any other condition that is at risk of being influenced by the study or that might have affected completion of the study.
• Patient refusal

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Fuclty of Medicine, Mansoura University

Al Mansurah, Dakahlia Governorate, 0020, Egypt

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome; Surgical Wound

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Study Officials

• mohamed mahmoud, MD

  Mansoura faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: consultant and lecturer of general surgery

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: November 2, 2023
• Study Start: November 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: November 30, 2022
• Last Updated: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)