Recurrent Laryngeal Nerve Injury, Thyroid Disease
Conditions
Keywords
Recurrent laryngeal nerve, Low-current stimulation, Thyroidectomy, Intraoperative nerve identification
Brief summary
This single-center prospective randomized interventional study evaluated whether intraoperative low-current stimulation could assist recurrent laryngeal nerve localization and reduce temporary recurrent laryngeal nerve injury during thyroid surgery.
Detailed description
A total of 150 patients undergoing thyroid surgery at the Second Affiliated Hospital of Kunming Medical University were randomly allocated in a 1:1:1 ratio to conventional anatomical identification, 3 mA low-current stimulation, or 5 mA low-current stimulation. All participants underwent preoperative and postoperative electronic laryngoscopy. The primary outcome was temporary recurrent laryngeal nerve injury. Secondary outcomes included permanent recurrent laryngeal nerve injury, operative duration, intraoperative blood loss, postoperative hospital stay, and stimulation-related adverse events.
Interventions
PROCEDURE3 mA low-current stimulation-assisted recurrent laryngeal nerve identification
Low-current stimulation at 3 mA was used as an adjunct to anatomical recurrent laryngeal nerve identification. Response was judged according to visible or palpable laryngeal twitch.
PROCEDURE5 mA low-current stimulation-assisted recurrent laryngeal nerve identification
Low-current stimulation at 5 mA was used as an adjunct to anatomical recurrent laryngeal nerve identification. Response was judged according to visible or palpable laryngeal twitch.
Sponsors
The Second Affiliated Hospital of Kunming Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Participants were randomized to one of three parallel groups: conventional anatomical identification, 3 mA low-current stimulation-assisted identification, or 5 mA low-current stimulation-assisted identification.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for thyroid surgery. * No history of prior thyroid or neck surgery. * Normal bilateral vocal cord mobility on preoperative electronic laryngoscopy. * Written informed consent provided before enrollment.
Exclusion criteria
* Preoperative recurrent laryngeal nerve dysfunction. * Previous neck surgery. * Incomplete clinical data. * Severe comorbidities precluding standardized perioperative assessment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Permanent Recurrent Laryngeal Nerve Injury Confirmed by Electronic Laryngoscopy | 6 months after surgery | Permanent recurrent laryngeal nerve injury is defined as unilateral or bilateral vocal cord paresis or paralysis detected after surgery and still present at the 6-month postoperative assessment, as confirmed by electronic laryngoscopy. The number of participants meeting this definition will be reported. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Vocal Cord Paresis or Paralysis Persisting at 6 Months, as Assessed by Electronic Laryngoscopy | 6 months after surgery | Permanent recurrent laryngeal nerve injury is defined as unilateral or bilateral vocal cord paresis or paralysis detected after surgery and still present at the 6-month postoperative assessment, as confirmed by electronic laryngoscopy. The number of participants meeting this definition will be reported. |
| Total Operative Duration in Minutes | Intraoperative period | Total operative duration will be measured in minutes from the initial skin incision to completion of skin closure. |
| Intraoperative blood loss | Intraoperative period | Estimated intraoperative blood loss measured in milliliters. |
| Duration of Postoperative Hospital Stay in Days | From the date of surgery until hospital discharge, assessed up to 30 days after surgery | Postoperative hospital stay will be calculated as the number of calendar days from the date of surgery to the date of hospital discharge. |
| Number of Participants With Stimulation-Related Adverse Events | From initiation of intraoperative nerve stimulation through 30 days after surgery | The number of participants experiencing at least one stimulation-related adverse event will be reported. Stimulation-related adverse events include suspected thermal injury, arrhythmia, hemodynamic instability, muscle burn, overstimulation, or suspected false-negative nerve localization, as documented in the intraoperative and postoperative medical records. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORSiqi Li
The Second Affiliated Hospital of Kunming Medical University
Outcome results
None listed