Study Comparing Harmonic Scalpel and Conventional Cold Steel Tonsil Removal Surgery in Children Requiring Tonsillectomy
Comparison of Harmonic Scalpel Versus Cold Steel Dissection Tonsillectomy in Children
This clinical trial aims to compare two commonly used methods of tonsil removal surgery (tonsillectomy) in children and adults with chronic tonsillitis. Chronic tonsillitis refers to repeated episodes of tonsil infection that occur frequently over several years and require surgical removal of the tonsils.
The main question this study aims to answer is:
Does tonsillectomy performed with a harmonic scalpel result in less pain three days after surgery compared with the conventional cold steel dissection technique?
Researchers will also compare:
How long the surgery takes to perform How much blood is lost during the operation The level of pain experienced three days after surgery
A total of 66 participants aged 5 to 45 years who are scheduled for tonsillectomy because of chronic tonsillitis will take part in the study. Participants will be randomly assigned to undergo either conventional cold steel dissection tonsillectomy or harmonic scalpel tonsillectomy.
All surgeries will be performed by experienced ENT surgeons following standard hospital procedures. After surgery, participants will receive routine medications and instructions for home care. They will be followed for three days and then return to the ENT clinic for assessment of pain and examination of the healing of the surgical site.
The study hypothesis is that patients undergoing harmonic scalpel tonsillectomy will experience less pain three days after surgery than those undergoing conventional cold steel dissection tonsillectomy.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Punjab Province
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Dera Ghazi Khan, Punjab Province, Pakistán, 32200
- Allama Iqbal Teaching Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- chronic tonsillitis and planned for tonsillectomy
Exclusion Criteria:
- Upper respiratory tract infection within preceding three weeks
- Peritonsillar abscess or history of quinsy
- Known bleeding disorder (hemophilia, thrombocytopenia) or on anticoagulant therapy
- Craniofacial anomalies or syndromic conditions affecting airway or surgical anatomy
- Uncontrolled diabetes, severe cardiopulmonary disease
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Cold Steel Dissection Tonsillectomy
Participants randomized to this arm will undergo conventional cold steel dissection tonsillectomy.
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The tonsils will be removed using cold steel instruments, and hemostasis will be achieved by bipolar diathermy or ligatures according to institutional protocol.
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Experimental: Harmonic Scalpel Tonsillectomy
Participants randomized to this arm will undergo extracapsular tonsillectomy using a harmonic scalpel
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A harmonic scalpel with a curved blade (Ethicon Endosurgery, Johnson & Johnson, USA) will be used for dissection and hemostasis (using ultrasonic energy) during tonsil removal.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Postoperative Pain Score
Periodo de tiempo: From surgery (day of tonsillectomy) to three (03) days postoperatively
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Postoperative pain will be assessed three days after tonsillectomy using the Visual Analogue Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst tolerable pain.
Mean VAS scores will be compared between the harmonic scalpel and cold steel dissection groups.
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From surgery (day of tonsillectomy) to three (03) days postoperatively
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Operative Time
Periodo de tiempo: During the surgical procedure (from insertion of mouth gag to removal after hemostasis).
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Duration of surgery measured in minutes from the start of tonsil dissection to completion of surgery and achievement of hemostasis.
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During the surgical procedure (from insertion of mouth gag to removal after hemostasis).
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Intraoperative Blood Loss
Periodo de tiempo: During the surgical procedure (from start of dissection to completion of hemostasis).
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Blood loss measured in milliliters using suction canister and pre-weighed sponges (1 g increase = 1 mL blood).
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During the surgical procedure (from start of dissection to completion of hemostasis).
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Sharbaz H Khosa, FCPS, Allama Iqbal Teaching Hospital
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
Palabras clave
Otros números de identificación del estudio
- U1111-1342-4276
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (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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