An observational study in Goiter, sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-17.
Sponsored by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla · Observational
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.
66 studies on the registry are indexed under Goiter; 11 are open to participants now.
This study's planned enrollment of 108 is close to the median of 104 across 23 observational studies indexed under Goiter.
Browse Goiter studies →Fundación Pública Andaluza para la gestión de la Investigación en Sevilla is the lead sponsor of 120 studies on the registry; 26 are open to participants now.
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Criteria to be verified during surgery (Intraoperative exclusion criteria):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HEMOPATCH® (Sealing / hemostatic patch of collagen and e polyethylene glycol)
No hemostatic or the standard (ligatures and oxidized cellulose regenerated).
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.
Time frame: Up to 18 hours.
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.
Time frame: 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.
Satisfaction survey at discharge and 30 days after the intervention.
Time frame: 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.
Time frame: 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.
Time frame: Up to 24 weeks.
This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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