RBR-5p2xqqr Diabetic neuropathy and recurrent laryngeal nerve involvement in patients undergoing thyroid surgery: evaluation of 50 c...

Date of registration: 09/29/2025 ^(mm/dd/yyyy)
Last approval date : 09/29/2025 ^(mm/dd/yyyy)

Study type:

Observational

Scientific title:

Trial identification

• UTN code: U1111-1322-2748

• Public title:

  en

  Diabetic neuropathy and recurrent laryngeal nerve involvement in patients undergoing thyroid surgery: evaluation of 50 cases

  pt-br

  Neuropatia Diabética e comprometimento do nervo laríngeo recorrente em pacientes submetidos a cirurgia de tireoide: avaliação de 50 Casos

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • 40685820.9.0000.5085
    Issuing authority: Plataforma Brasil
  • 4.810.679
    Issuing authority: Comitê de Ética em Pesquisa do Hospital e Maternidade São Domingos

Sponsors

• Primary sponsor: Hospital São Domingos
• Secondary sponsor:
  • Institution: Hospital São Domingos
• Supporting source:
  • Institution: Hospital São Domingos

Health conditions

• Health conditions:

  en

  Thyroidectomy

  pt-br

  Tireoidectomia

• General descriptors for health conditions:

  en

  C18.452.394.750 Diabetes Mellitus

  pt-br

  C18.452.394.750 Diabetes Mellitus

• Specific descriptors:

  en

  E04.270.856 Thyroidectomy

  pt-br

  E04.270.856 Tireoidectomia

Interventions

• Interventions:

  en

  This is a prospective, observational and comparative study, with a quantitative approach, carried out at Hospital São Domingos, in São Luís - Maranhão, from March 2021 to February 2025. The study population consisted of 50 patients who underwent elective thyroidectomy surgeries, with or without a diagnosis of diabetes. All patients were invited to voluntarily participate in the preoperative study, with confirmation by signing the Informed Consent Form. Epidemiological, clinical, and surgical data were collected perioperatively. During the procedure, the recurrent laryngeal nerve was monitored using the CANUMA C2 SELECT 360 DEGREES/RECURRENT STIMULATION 4-CHANNEL SYSTEM – INOMED. Subsequently, the patient was contacted (between 1 and 2 weeks postoperatively) to inquire about the occurrence of complications. The study compared intraoperative latency of the recurrent laryngeal nerve, as well as laboratory results and complications among diabetic and non-diabetic patients

  pt-br

  Trata-se de um estudo prospectivo, observacional e comparativo, com abordagem quantitativa, realizada no Hospital São Domingos, em São Luís - Maranhão, no período de março de 2021 a fevereiro de 2025. A população de estudo foi composta por 50 pacientes submetidos a cirurgias eletivas de tireoidectomia, com ou sem diagnóstico de diabetes. Todos os pacientes foram convidados a participar voluntariamente da pesquisa no pré-operatório, com confirmação mediante assinatura do Termo de Consentimento Livre e Esclarecidos. Os dados epidemiológicos, clínicos e cirúrgicos foram coletados no perioperatório. Durante o procedimento, ocorreu a monitorização do nervo laríngeo recorrente utilizando o sistema KIT CANUMA C2 SELECT 360 GRAUS/ESTIMULAÇÃO RECORRENTE 4 CANAIS – INOMED. Posteriormente, entrava-se em contato com o paciente (entre 1 e 2 semanas de pós-operatório) para indagar sobre a ocorrência de complicações. O estudo comparou a latência medida no intraoperatório do nervo laríngeo recorrente, bem como resultados laboratoriais e complicações entre pacientes diabéticos e não diabéticos

• Descriptors:

  en

  C10.668.829.300 Diabetic Neuropathies

  pt-br

  C10.668.829.300 Neuropatias Diabéticas

Recruitment

• Study status: Data analysis completed
• Countries
  • Brazil
• Date first enrollment: 03/01/2021 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  50	-	18 Y	80 Y

• Inclusion criteria:

  en

  Volunteers of both sexes; age between 18 and 80 years; with or without a diagnosis of Diabetes; undergoing Elective Thyroidectomy Surgeries; laboratory tests collected within 90 days of the date of Surgery; signing of the informed consent form

  pt-br

  Voluntários de ambos os sexos; idade entre 18 e 80 anos; com ou sem diagnóstico de Diabetes; submetidos a Cirurgias Eletivas de Tireoidectomia; exames laboratoriais coletados em período inferior a 90 dias da data da Cirurgia; assinatura do termo de consentimento livre e esclarecido

• Exclusion criteria:

  en

  Volunteers with comorbidities that could interfere with glycated hemoglobin values, such as Sickle Cell Anemia or Iron Deficiency; Blood Transfusion in the last year; Dialysis in the 90 days prior to the Surgical Procedure

  pt-br

  Voluntários com comorbidades que pudessem interferir nos valores da hemoglobina glicada, como Anemia Falciforme ou Deficiência de Ferro; Transfusão Sanguínea no último ano; Diálise nos 90 dias anteriores ao Procedimento Cirúrgico

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase

Outcomes

• Primary outcomes:

  en

  A difference in recurrent laryngeal nerve latency was found between diabetic and non-diabetic patients, with no statistically relevant complication rates

  pt-br

  Encontrou-se diferença de latência do nervo laríngeo recorrente entre pacientes diabéticos e não diabéticos, sem taxas de complicações estatisticamente relevantes

• Secondary outcomes:

  en

  The length of hospital stay and the occurrence of hypoparathyroidism were evaluated, classified according to the Clavien-Dindo Classification

  pt-br

  Avaliou-se o tempo de internação hospitalar e a ocorrência de hipoparatireoidismo, classificados conforme a Classificação de Clavien-Dindo

Contacts

• Public contact
  • Full name: Caio Marcio Barros de Oliveira
  • • Address: Avenida dos Portugueses, 1966 - Bacanga
    • City: São Luis / Brazil
    • Zip code: 65080-805
  • Phone: +55 (98) 981810055
  • Email: caio.marcio@ufma.br
  • Affiliation: Universidade Federal do Maranhão
   
• Scientific contact
  • Full name: Caio Marcio Barros de Oliveira
  • • Address: Avenida dos Portugueses, 1966 - Bacanga
    • City: São Luis / Brazil
    • Zip code: 65080-805
  • Phone: +55 (98) 981810055
  • Email: caio.marcio@ufma.br
  • Affiliation: Universidade Federal do Maranhão
   
• Site contact
  • Full name: Caio Marcio Barros de Oliveira
  • • Address: Avenida dos Portugueses, 1966 - Bacanga
    • City: São Luis / Brazil
    • Zip code: 65080-805
  • Phone: +55 (98) 981810055
  • Email: caio.marcio@ufma.br
  • Affiliation: Universidade Federal do Maranhão
   

Additional links:

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