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Trial · NCT07274696

Mecobalamin in Promoting Recurrent Laryngeal Nerve Function Recovery After Thyroid Surgery

NCT07274696, Phase 3, Not yet recruiting, West China Hospital

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Mecobalamin in Promoting Recurrent Laryngeal Nerve Function Recovery After Thyroid Surgery. Trials, record NCT07274696. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07274696

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Mecobalamin in Promoting Recurrent Laryngeal Nerve Function Recovery After Thyroid Surgery
NCT number
NCT07274696
Status
Not yet recruiting
Phases
Phase 3
Enrollment
528 participants, estimated
Lead sponsor
West China Hospital
Conditions
Patients Undergoing Open Thyroid Surgery
Interventions
Mecobalamin, placebo
First posted
2025-12-10
Last updated
2025-12-10

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryJitterPreoperative, within two weeks after surgery, 1 month postoperative, 3 months postoperative, and 6 months postoperativeJitter reflects the regularity of the voice in terms of frequency. A smaller jitter value indicates higher regularity of the voice in terms of frequency.
PrimaryShimmerPreoperative, within two weeks after surgery, 1 month postoperative, 3 months postoperative, and 6 months postoperativeShimmer reflects the regularity of the voice in terms of amplitude. A smaller shimmer value indicates higher regularity of the voice in terms of amplitude.
PrimaryFundamental frequency (F0)Preoperative, within two weeks after surgery, 1 month postoperative, 3 months postoperative, and 6 months postoperative
PrimaryMaximum Phonational Frequency Range (MPFR)Preoperative, within two weeks after surgery, 1 month postoperative, 3 months postoperative, and 6 months postoperativeThe frequency range from the lowest to the highest pitch a person can produce (in Hz or semitones).
PrimaryNoise-to-Harmonic Ratio (NHR)Preoperative, within two weeks after surgery, 1 month postoperative, 3 months postoperative, and 6 months postoperative
The NHR parameter is the ratio of non-harmonic components within the 1,500-4,500 Hz range to harmonic components within the 70-4,500 Hz range. It can be used to assess the proportion of noise components in the voice.
SecondaryThe Voice Handicap Index-10 (VHI-10)Preoperative, 1 day postoperative, 1 month postoperative, 3 months postoperative, and 6 months postoperative
The VHI-10 is a voice disorder index scale containing 10 items, comprising 5 functional items, 3 physical items, and 2 emotional items. Each item is scored from 0 to 4, with different scores representing the frequency of occurrence for that item: "Never" is 0 points; "Almost Never" is 1 point; "Sometimes" is 2 points; "Almost Always" is 3 points; and "Always" is 4 points. A higher score indicates a greater impact of the voice disorder in that domain and a more severe self-assessment of the voice disorder by the subject. The critical value for the VHI-10 is 8 points, and subjects with a VHI score ≥ 8 are classified as having a voice disorder.
SecondaryThe Voice-Related Quality of Life (V-RQOL-10) scalePreoperative, 1 day postoperative, 1 month postoperative, 3 months postoperative, and 6 months postoperative
Consists of 10 items, encompassing two domains: social-emotional and physical-functioning. The items describe the subjective experiences of patients with voice disorders. Severity is rated on a 5-point scale, where 1 represents "none," 2 represents "a little," 3 represents "a moderate amount," 4 represents "a lot," and 5 represents "a great deal." This questionnaire uses "reverse scoring," and the final scores need to be transformed to a 0 to 100 scale. A higher overall score indicates better voice-related quality of life, while a lower score indicates worse voice-related quality of life.
SecondaryThe subjective auditory-perceptual assessment of voice quality (GRBAS Scale)Preoperative, 1 day postoperative, 1 month postoperative, 3 months postoperative, and 6 months postoperative
This scale consists of five parameters: overall grade of hoarseness (G), roughness (R), breathiness (B), asthenia (A), and strain (S). Each parameter is rated on a severity scale from 0 to 3: 0 indicates normal, 1 indicates mild deviation, 2 indicates moderate deviation, and 3 indicates severe deviation. A higher score represents a more severe voice disorder. The assessment is conducted by professional audiologists, voice specialists, and the patient's family members.
SecondaryStroboscopyPreoperative, If necessary after surgery
This examination utilizes the principle of persistence of vision to observe the vocal cords in a seemingly stationary or slow-motion vibrating state through visual superposition. Dynamic laryngoscopy is performed preoperatively, and the stroboscopic findings are recorded. Postoperatively, it is conducted on patients presenting with voice abnormalities, dysphonia, or suspected abnormal vocal cord mobility to confirm the mobility of the vocal cords.
SecondaryIntraoperative neural signalsIntraoperativeDuring the surgery, IONM technology was used to monitor neural signals from the vagus nerve, recurrent laryngeal nerve, and superior laryngeal nerve both before and after nerve exposure.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
10219748RESULTPubMed
12454521RESULTPubMed
23817134RESULTPubMed
26300733RESULTPubMed
39192360RESULTPubMed
40935571RESULTPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07274696

GET https://conductscience.org/api/trials/v1/NCT07274696/registered