Drainless Thyroidectomy by the Sutureless Technique for Benign Thyroid Diseases
Safety and Feasibility of Drainless Thyroid Surgery for Benign Thyroid Diseases Using the Sutureless Technique, Rrandomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Thyroidectomy for benign thyroid diseases is commonly performed with routine placement of surgical drains to prevent postoperative hematoma or seroma. However, drain use may be associated with increased pain, infection risk, prolonged hospital stay, and patient discomfort. Advances in surgical techniques, particularly the use of sutureless energy-based hemostatic devices, have raised the possibility of safely omitting routine drain placement in selected patients.
This prospective randomized controlled trial aims to assess the safety and feasibility of drainless thyroid surgery in patients with benign thyroid diseases. Eligible patients undergoing thyroidectomy are randomly allocated into two groups: a drainless group, in which no postoperative drain is inserted, and a control group, in which a conventional closed suction drain is placed.
All surgeries are performed using a standardized sutureless technique for hemostasis. Patients are followed postoperatively to evaluate surgical and clinical outcomes, including postoperative bleeding or hematoma, seroma formation, wound complications, hypocalcemia, recurrent laryngeal nerve injury, postoperative pain, length of hospital stay, and need for reintervention or readmission.
The results of this study are expected to clarify whether drainless thyroid surgery using a sutureless technique is a safe and feasible alternative to conventional drain placement in benign thyroid surgery and may help optimize postoperative care and patient comfort
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Minya, Egipto, 61111
- Minia University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adult patients (≥18 years)
- Benign thyroid disease confirmed by: clinical assessment, ultrasonography, and fine-needle aspiration cytology (Bethesda II)
- Indicated for elective hemithyroidectomy or total thyroidectomy
- Euthyroid or adequately controlled thyroid function
Exclusion Criteria:
- Thyroid malignancy or indeterminate cytology
- Re-operative thyroid surgery
- Retrosternal goiter
- Coagulation disorders
- Patients on anticoagulation that could not be safely discontinued
- Concomitant neck surgery
- Severe uncontrolled systemic illness (ASA IV or higher)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: thyroidectomy without drain
Participants in this arm undergo sutureless thyroidectomy procedure, but no surgical drain is placed afterward.
The aim is to evaluate whether omitting the drain affects outcomes such as postoperative surgical site complications (like pain, infection, seroma, hematoma) compared with the drained approach.
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Participants undergo sutureless thyroidectomy procedure but no drain is placed postoperatively.
The goal is to assess whether omitting the drain affects postoperative outcomes such as pain, seroma, hematoma, infection, or overall recovery, while maintaining safety.
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Comparador activo: thyroidectomy with drain
Participants in this arm undergo sutureless thyroidectomy for benign thyroid disease with placement of a subcutaneous suction drain at the end of the procedure.
The purpose of using the drain is to evacuate any postoperative fluid such as blood or serous fluid from the surgical site to theoretically reduce complications such as hematoma or seroma accumulation.
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Participants undergo sutureless thyroidectomy for benign thyroid disease with placement of a subcutaneous suction drain.
The drain is intended to evacuate postoperative fluid (blood or serous fluid) to reduce the risk of complications such as hematoma or seroma formation.
The surgical technique itself follows conventional sutureless thyroidectomy principles.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Incidence of postoperative neck hematoma requiring intervention
Periodo de tiempo: Within 48 hours postoperatively
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Any postoperative cervical hematoma causing airway compromise or requiring surgical re-exploration or invasive evacuation
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Within 48 hours postoperatively
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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1. Overall postoperative complication rate
Periodo de tiempo: Within 30 days postoperatively
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Definition: Composite of hematoma, seroma, wound infection, hypocalcemia, and recurrent laryngeal nerve injury
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Within 30 days postoperatively
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2. Seroma formation
Periodo de tiempo: Within 14 days postoperatively
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Clinically or ultrasonographically detected fluid collection requiring aspiration
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Within 14 days postoperatively
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3. Postoperative hypocalcemia
Periodo de tiempo: Within 72 hours postoperatively
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Corrected serum calcium < 8.5 mg/dL and/or symptoms requiring calcium supplementation
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Within 72 hours postoperatively
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Recurrent laryngeal nerve injury
Periodo de tiempo: Within 30 days postoperatively
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Postoperative vocal cord paresis/paralysis confirmed by laryngoscopy
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Within 30 days postoperatively
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- MUFMIRB9251023
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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