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Observational study with non-inferiority, prospective, randomized (1: 1) and open-label medical device. The study has 2 treatment groups (HEMOPATCH® versus standard hemostasis).
The main objective is to determine if there is a reduction in the volume of exudate in the surgical bed with the application of the collagen and polyethylene glycol hemostatic agent.
The present study includes patients undergoing total thyroidectomy for multinodular goiter in the Endocrine Surgery Unit of the Virgen del Rocío University Hospital.
The estimated sample calculation of patients enrolled in the study is 108 (2 groups, 1:1 ratio).
The patients don´t know what type of hemostatic the patients are going to receive (single blind).
The duration of patient follow-up will be 30 +/- 10 days after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (Study Group) | HEMOPATCH® (Sealing / hemostatic patch of collagen and e polyethylene glycol) | ||
| Group B (Control Group) | No hemostatic or the standard (ligatures and oxidized cellulose regenerated). |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of changes in the exudate volume of the surgical bed with the application of the hemostatic agent of collagen and polyethylene glycol. | Fixed periods of time will be established to evaluate the exudate from the surgical bed. It will be evaluated 18 hours after surgery by cervical ultrasound. | Up to 18 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of changes in the patient's symptoms in the postoperative period of thyroidectomy after the application of the hemostatic agent of collagen and polyethylene glycol. | Decrease in the number of dyspnea at 24 hours and 30 days postoperatively. | Up to 4 weeks. |
| Improvement in patient satisfaction after the application of the collagen and polyethylene glycol hemostatic agent, in relation to the surgical experience in the postoperative period of thyroidectomy. |
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Inclusion Criteria:
Exclusion Criteria:
Criteria to be verified during surgery (Intraoperative exclusion criteria):
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The present study includes older patients who underwent total thyroidectomy for multinodular goiter in the Endocrine Surgery Unit of the Virgen del Rocío University Hospital. They must sign an informed consent and know the study procedures that are detailed in the protocol.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Manuel Martos Martínez | Contact | 955 01 20 00 | jmmartos66@gmail.com | |
| Carlos García Pérez | Contact | 955 04 31 27 | administracion.eecc.hvm.sspa@juntadeandalucia.es |
| Name | Affiliation | Role |
|---|---|---|
| Juan Manuel Martos Martínez | Hospitales Universitarios Virgen del Rocío | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Virgen del Rocío | Recruiting | Seville | 41013 | Spain |
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| ID | Term |
|---|---|
| D006042 | Goiter |
| ID | Term |
|---|---|
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
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Satisfaction survey at discharge and 30 days after the intervention. |
| Up to 4 weeks. |
| Rate of improvement in postoperative complications of thyroidectomy after the application of the collagen and polyethylene glycol hemostatic agent. | Performance of the Trousseau test every 8 hours from surgery to hospital discharge and Calcemia (mg/dl) at discharge and at check-up in consultations (30 days) with total proteins. | Up to 4 weeks. |
| Incidence rate of adverse effects after the use of the collagen and polyethylene glycol hemostatic agent in thyroid surgery. | Number of adverse events that have occurred in study patients. | Up to 24 weeks. |