FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
Comparison of Outcomes in Functional Endoscopic Sinus Surgery(FESS) With or Without Preoperative Intranasal Desmopressin in Patients of Chronic Rhinusinusitis With Bilateral Nasal Polyposis
Chronic rhinosinusitis with nasal polyps is a condition that causes long-lasting inflammation and swelling in the nose and sinuses and may lead to nasal blockage, nasal discharge, facial pressure, and reduced sense of smell. Functional Endoscopic Sinus Surgery (FESS) is a surgical treatment used when medical treatment has not adequately controlled the condition.
Bleeding during FESS can make it difficult for the surgeon to see and operate safely. This randomized controlled trial will compare FESS performed with and without preoperative intranasal desmopressin in patients with chronic rhinosinusitis with nasal polyps. Patients will be randomly assigned to one of two groups. The intervention group will receive 20 micrograms of intranasal desmopressin 30-60 minutes before surgery, while the control group will undergo FESS without preoperative desmopressin.
The study will assess intraoperative blood loss, quality of the surgical field, operative time, surgeon satisfaction, and perioperative complications. The study will include patients undergoing elective FESS at the Department of Otorhinolaryngology, Services Hospital, Lahore.
The purpose of this study is to determine whether preoperative intranasal desmopressin can reduce bleeding and improve the surgical field during FESS. The findings may provide local evidence to help inform perioperative management of patients undergoing FESS for chronic rhinosinusitis with nasal polyps.
Descripción general del estudio
Estado
Estado
Condiciones
Condiciones
Intervención / Tratamiento
Intervención / Tratamiento
Descripción detallada
Chronic rhinosinusitis with nasal polyposis (CRSwNP) is a chronic inflammatory condition affecting the nose and paranasal sinuses. Patients may experience persistent nasal obstruction, nasal discharge, facial pressure, and reduced or lost sense of smell. Functional Endoscopic Sinus Surgery (FESS) is performed in patients whose symptoms persist despite appropriate medical treatment.
Intraoperative bleeding is an important consideration during FESS because blood can interfere with visualization of the surgical field and make identification of anatomical structures and surgical dissection more difficult. The study is designed to investigate whether preoperative intranasal desmopressin may influence operative conditions during FESS.
This is a randomized controlled trial to be conducted in the Department of Otorhinolaryngology at Services Hospital, Lahore. Eligible patients with chronic rhinosinusitis with bilateral nasal polyps who are scheduled for elective FESS will be considered for participation. Patients will be randomly allocated into two groups using a computer-generated randomization sequence, with allocation concealment through sequentially numbered opaque sealed envelopes.
Participants assigned to the intervention group will receive 20 μg of intranasal desmopressin, administered as 10 μg in each nostril approximately 30-60 minutes before induction of anesthesia. Participants in the control group will undergo FESS without preoperative intranasal desmopressin. General anesthesia and standardized endoscopic surgical techniques will be used for the procedures.
The study will evaluate intraoperative blood loss and the quality of the surgical field. Blood loss will be estimated using the suction canister volume after accounting for irrigation fluid, together with estimation of blood absorbed by surgical patties and nasal packs. Surgical-field quality will be assessed using the Boezaart Surgical Field Grading Scale. Additional outcomes include operative duration, surgeon satisfaction, nasal packing requirement, postoperative bleeding, and perioperative complications.
The study population will consist of adults aged 18-60 years with chronic rhinosinusitis with bilateral nasal polyps who are planned for elective FESS and meet the specified eligibility criteria. Patients with conditions such as known bleeding disorders, use of anticoagulant or antiplatelet medication, hyponatremia or previous hyponatremia, uncontrolled hypertension, significant cardiovascular disease, fungal rhinosinusitis with polyps, or previous revision FESS will be excluded according to the study protocol.
The collected data will be analyzed using SPSS version 26.0. Continuous and categorical outcomes will be analyzed using statistical tests appropriate to their distribution and measurement characteristics. The study will use a two-sided significance level of p ≤ 0.05.
The study is intended to determine whether the addition of preoperative intranasal desmopressin is associated with differences in operative conditions during FESS for CRSwNP. The findings will provide evidence regarding intraoperative blood loss, surgical-field quality, operative duration, and other perioperative outcomes in the study population.
Tipo de estudio
Tipo de estudio
Inscripción (Estimado)
Inscripción
Fase
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
Estudio Contacto
- Nombre: Daniyal Babar, MS(ENT)
- Número de teléfono: +923114214929
- Correo electrónico: daniyallhr99@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Noman Ali, MS(ENT)
- Número de teléfono: +923053399793
- Correo electrónico: nomi.mbbs@gmail.com
Criterios de participación
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Patients aged 18-60 years.
- Diagnosed cases of chronic rhinosinusitis with bilateral nasal polyps.
- Patients planned for elective Functional Endoscopic Sinus Surgery (FESS).
- Patients with ASA physical status I or II.
Exclusion Criteria:
- Known bleeding disorders.
- Fungal rhinosinusitis with polyps.
- Use of anticoagulant or antiplatelet drugs.
- Hyponatremia or history of hyponatremia.
- Ischemic heart disease or uncontrolled hypertension.
- Revision FESS.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Número de brazos
Armas e Intervenciones
Grupo de participantes/brazoGrupo de participantes/brazo |
Intervención / TratamientoIntervención / Tratamiento |
|---|---|
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Experimental: Intervention
Participants will receive intranasal desmopressin 20 μg (10 μg in each nostril) 30-60 minutes before induction of anesthesia, followed by Functional Endoscopic Sinus Surgery (FESS). |
Intranasal desmopressin 20 μg (10 μg in each nostril) will be administered 30-60 minutes before induction of anesthesia in participants undergoing Functional Endoscopic Sinus Surgery (FESS). |
|
Comparador activo: Control
Participants will undergo Functional Endoscopic Sinus Surgery (FESS) without preoperative intranasal desmopressin. |
Participants will undergo Functional Endoscopic Sinus Surgery (FESS) without preoperative intranasal desmopressin. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Intraoperative Blood Loss During Functional Endoscopic Sinus Surgery
Periodo de tiempo: During surgery (intraoperative period)
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Total intraoperative blood loss during FESS, measured in milliliters (mL). Blood loss will be calculated from the volume collected in the suction canister after subtracting the volume of irrigation fluid used during surgery and adding the estimated blood volume absorbed by blood-soaked nasal patties and surgical packs. |
During surgery (intraoperative period)
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Quality of Surgical Field During FESS
Periodo de tiempo: During surgery (intraoperative period)
|
Quality of the surgical field will be assessed using the Boezaart Surgical Field Grading Scale, ranging from Grade 0 (no bleeding) to Grade 5 (severe bleeding requiring constant suctioning and preventing surgical dissection). |
During surgery (intraoperative period)
|
Colaboradores e Investigadores
Patrocinador
Patrocinador
Investigadores
Investigadores
- Investigador principal: Daniyal Babar, Services Institute of Medical Sciences, Pakistan
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
Finalización primaria (Estimado)
Finalización primaria
Finalización del estudio (Estimado)
Finalización del estudio
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Publicado por primera vez
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
Otros números de identificación del estudio
- IRB/2026/1813/SIMS
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Individual participant data will not be shared with other researchers. Study data will be used by the research team for the purposes of this study and will be maintained confidentially in accordance with applicable ethical and institutional requirements.
Información sobre medicamentos y dispositivos, documentos del estudio
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