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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Participants underwent conventional anatomical identification and preservation of the recurrent laryngeal nerve during thyroid surgery. | |
| 3 mA group | Experimental | Participants underwent 3 mA low-current stimulation-assisted recurrent laryngeal nerve identification in addition to conventional anatomical identification. |
|
| 5 mA group | Experimental | Participants underwent 5 mA low-current stimulation-assisted recurrent laryngeal nerve identification in addition to conventional anatomical identification. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3 mA low-current stimulation-assisted recurrent laryngeal nerve identification | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Permanent Recurrent Laryngeal Nerve Injury Confirmed by Electronic Laryngoscopy | 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. | 6 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Vocal Cord Paresis or Paralysis Persisting at 6 Months, as Assessed by Electronic Laryngoscopy | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Siqi Li | The Second Affiliated Hospital of Kunming Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital of Kunming Medical University | Kunming | Yunnan | 650000 | China |
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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.
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| 5 mA low-current stimulation-assisted recurrent laryngeal nerve identification | Procedure | 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. |
|
| 6 months after surgery |
| Total Operative Duration in Minutes | Total operative duration will be measured in minutes from the initial skin incision to completion of skin closure. | Intraoperative period |
| Intraoperative blood loss | Estimated intraoperative blood loss measured in milliliters. | Intraoperative period |
| Duration of Postoperative Hospital Stay in Days | Postoperative hospital stay will be calculated as the number of calendar days from the date of surgery to the date of hospital discharge. | From the date of surgery until hospital discharge, assessed up to 30 days after surgery |
| Number of Participants With Stimulation-Related Adverse Events | 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. | From initiation of intraoperative nerve stimulation through 30 days after surgery |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D061226 | Recurrent Laryngeal Nerve Injuries |
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
| D061224 | Laryngeal Nerve Injuries |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D061223 | Vagus Nerve Injuries |
| D020209 | Cranial Nerve Injuries |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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