Patients scheduled for anatomical thyroidectomy
Conditions
Interventions
Obtain informed consent from the participants, and in cases where persistent exudative bleeding occurs after thyroid dissection, apply PuraStat to assess the hemostatic success rate and safety.
Sponsors
Mukaigawa Takashi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Age at the time of obtaining consent is 18 years or older. (2) ECOG performance status (PS) is 0 or 1. (3) Surgical treatment is scheduled within 2 weeks after obtaining consent. (4) Anatomical thyroidectomy is planned (surgical procedures include total thyroidectomy, hemithyroidectomy, endoscopic total thyroidectomy, or endoscopic hemithyroidectomy). (5) Major organ functions are preserved. (6) Written informed consent has been obtained from the patient after sufficient explanation of the study contents prior to enrollment.
Exclusion criteria
Exclusion criteria: (1) Patients with vocal cord paralysis confirmed by preoperative laryngoscopy test. (2) Patients undergoing tracheostomy associated with combined tracheal resection. (3) Patients requiring closure of the esophageal mucosa and muscular layer due to combined esophageal resection. (4) Patients with local infections requiring treatment or active systemic infections. (5) Pregnant or lactating women, women who may currently be pregnant, or women unwilling to use contraception during the study period. (6) Patients with a history of disorders associated with coagulation. (7) Patients for whom study enrollment is considered difficult due to clinically significant psychiatric disorders. (8) Patients receiving continuous systemic administration of corticosteroids or immunosuppressive agents. (9) Patients with a history of hypersensitivity to peptide or protein preparations. (10) Patients with a history of severe hypersensitivity. (11) Patients deemed inappropriate for participation by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion requiring additional hemostatic intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Time from PuraStat application to achievement of hemostasis Proportion requiring intraoperative additional hemostatic procedures Time required for preparation of PuraStat Total hemostasis time Amount of PuraStat used Duration of drain placement Drainage amount Length of postoperative hospital stay Intraoperative complications Adverse events within 30 days postoperatively Adverse events within 90 days postoperatively Incidence of postoperative rebleeding Rate of decrease in electromyography (EMG) amplitude before and after hemostasis Incidence of postoperative vocal cord mobility impairment | — |
Contacts
Public ContactNobuyuki Sakuma
Shizuoka Cancer Center
Outcome results
None listed