Swedish National Parotidectomy Study (SNaPs): Drainless Versus Standard Surgery (SNaPs)
2 de junio de 2026 actualizado por: Karl Sandström, Uppsala University Hospital
A Prospective, Randomized, Multicenter Non-Inferiority Trial Evaluating the Safety of Parotidectomy Without Active Surgical Drainage (Svenska Nationella Parotisstudien)
The purpose of this study The purpose of this study is to find out if it is safe to perform surgery on the parotid gland (the large salivary gland in front of the ear) without using a wound drain. A wound drain is a small plastic tube used to remove excess fluid from the surgical site after the operation. Currently, using a drain is the standard practice in Sweden, which often means patients must stay in hospital overnight. Researchers want to see if skipping the drain is just as safe and if it could allow more patients to return home on the same day as their surgery.
What happens during the study
Participants in this study will be randomly assigned to one of two groups during their surgery:
Group 1: Will receive the standard treatment with a wound drain.
Group 2: Will have the surgery performed without a wound drain.
Apart from the use of a drain, all participants will receive the same surgical care. After the operation, researchers will monitor the healing process. Participants will be asked to fill out questionnaires about their health and any symptoms at one week and six months after their surgery.
The goal of the study The main goal is to compare the safety of the two methods. Researchers will look at whether there is any difference in the number of complications, such as fluid build-up (seroma), bleeding, or infections, between those who had a drain and those who did not. The study also aims to evaluate if avoiding a drain improves the patient's quality of life and if it is a more cost-effective approach for the healthcare system.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
600
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Karl Sandström, MD, PhD
- Número de teléfono: +46 76 113 29 52
- Correo electrónico: karl.sandstrom@akademiska.se
Ubicaciones de estudio
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Stockholm, Suecia
- Reclutamiento
- Karolinska University Hospital
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Trollhättan, Suecia
- Reclutamiento
- NÄL
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Uppsala, Suecia
- Reclutamiento
- Uppsala University Hospital, Department of Otorhinolaryngology
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Contacto:
- Karl Sandström, MD, PhD
- Número de teléfono: +46 76 113 29 52
- Correo electrónico: karl.sandstrom@akademiska.se
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Patients scheduled to undergo partial or superficial parotidectomy without concurrent soft tissue surgery, in cases where a wound drain is traditionally used (extirpation of single adjacent lymph nodes is acceptable).
- ASA physical status class 1-3.
- Aged 18 years or older.
- The patient understands the participant information and is able to make an informed choice.
Exclusion Criteria:
- Previous parotid surgery on the same side
- Tumour with parapharyngeal extension.
- Ongoing or planned perioperative treatment with tranexamic acid.
- Ongoing treatment with dual antiplatelet therapy (single agent therapy, such as Aspirin or Clopidogrel, is not an exclusion criterion).
- Ongoing treatment with anticoagulants (NOAC, Warfarin) at the time of surgery. NOAC must be discontinued at least 24 hours before surgery.
- Ongoing treatment with low molecular weight heparin in doses higher than: Fragmin 5000 IU/day, Clexane 40 mg/day, or Innohep 4500 IU/day.Ongoing treatment for malignancy.Known coagulation disorder.
- Platelet count <150 x 10⁹
- PK-INR >1.2.
- Hb <120 g/L.
- APTT >42s.
- Preoperative impaired facial nerve function on the affected side (Sunnybrook Facial Grading System score <90).
- Supplementary postoperative treatment such as radiotherapy or extended surgery.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Drainless Group (Intervention)
Participants in this group will undergo partial or superficial parotidectomy without the placement of a postoperative active wound drain.
The surgical site is closed according to the standard technique, but the suction drain is omitted.
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The surgical procedure is performed without the insertion of an active suction drain.
All other aspects of the surgical care and postoperative monitoring follow standard protocols.
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Comparador activo: Standard Drain Group (Control)
Participants in this group will undergo partial or superficial parotidectomy with the placement of a postoperative active wound drain, according to current standard clinical routine in Sweden.
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An active suction drain is placed in the surgical bed before wound closure, which is the current established clinical practice for parotidectomy in Sweden.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cumulative incidence of early postoperative complications requiring intervention
Periodo de tiempo: From the day of surgery up to 7 weeks postoperatively.
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The primary outcome is the number of participants experiencing at least one early complication, defined as a salivary fistula, haematoma, seroma/sialocele, or surgical site infection that requires invasive or medical treatment (e.g., aspiration, re-operation, or antibiotics).
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From the day of surgery up to 7 weeks postoperatively.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Requirement for inpatient hospital care after the day of surgery.
Periodo de tiempo: From the first postoperative day up to 6 months
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Evaluation of the number of participants requiring unplanned hospital admission or prolonged stay related to the surgical procedure.
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From the first postoperative day up to 6 months
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Postoperative facial nerve function.
Periodo de tiempo: Baseline (preoperative), at discharge, at 7 weeks, and at 6 months
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Assessment of facial nerve function using the Sunnybrook Facial Grading System (SFGS).
The SFGS is a clinical evaluation scale that ranges from 0 to 100.
A score of 0 indicates complete facial paralysis, while a score of 100 represents normal facial function.
Higher scores indicate a better outcome (better facial nerve function).
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Baseline (preoperative), at discharge, at 7 weeks, and at 6 months
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Incidence of Frey's syndrome
Periodo de tiempo: 6 months postoperatively.
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Subjective and objective assessment of gustatory sweating (Frey's syndrome).
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6 months postoperatively.
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Health-related quality of life (EQ-5D-5L)
Periodo de tiempo: 7 weeks, and 6 months postoperatively
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Evaluated using the EQ-5D-5L descriptive system, which comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression).
Each dimension is scored from 1 (no problems) to 5 (extreme problems).
The digits are combined into a 5-digit health state profile, which is then converted into a single index value.
Index values range from less than 0 (where 0 is a state equivalent to death and negative values are states worse than death) to 1.0 (perfect health).
Higher scores indicate a better quality of life outcome.
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7 weeks, and 6 months postoperatively
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Postoperative length of stay
Periodo de tiempo: Through initial hospital discharge, an average of 1.5 days, assessed up to 7 weeks.
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Total number of days spent in hospital following the surgical procedure.
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Through initial hospital discharge, an average of 1.5 days, assessed up to 7 weeks.
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Symptom-specific outcomes (SwPOI-8)
Periodo de tiempo: 7 weeks and 6 months postoperatively
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Measured using the Swedish Parotidectomy Outcome Inventory 8 (SwPOI-8), a disease-specific instrument assessing subjective symptoms after parotid surgery (e.g., pain, sensory disturbances, scarring, facial palsy, sweating, dry mouth).
Each of the 8 items is scored on a Likert scale from 0 to 3, with a total score ranging from 0 to 24.
Higher scores indicate a greater symptom burden and a worse outcome.
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7 weeks and 6 months postoperatively
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
6 de mayo de 2026
Finalización primaria (Estimado)
1 de diciembre de 2030
Finalización del estudio (Estimado)
1 de diciembre de 2032
Fechas de registro del estudio
Enviado por primera vez
19 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
26 de mayo de 2026
Publicado por primera vez (Actual)
2 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
2 de junio de 2026
Última verificación
1 de junio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades de la Boca
- Enfermedades Estomatognáticas
- Procesos Patológicos
- Neoplasias por sitio
- Neoplasias
- Hemorragia
- Inflamación
- Neoplasias de Cabeza y Cuello
- Enfermedades de las glándulas salivales
- Neoplasias de la Boca
- Enfermedades de las parótidas
- Neoplasias de las glándulas salivales
- Condiciones Patológicas, Signos y Síntomas
- Hematoma
- Complicaciones Postoperatorias
- Neoplasias de parótida
- Seroma
- Administración de Servicios de Salud
- Calidad, acceso y evaluación de la atención médica
- Calidad de la atención médica
- Indicadores de calidad, atención médica
- Estándar de cuidado
Otros números de identificación del estudio
- 2025-07555-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data will not be shared publicly due to current Swedish legislation and the European General Data Protection Regulation (GDPR), which protect the privacy of study participants.
Sharing of pseudonymised individual-level data would require specific legal review and institutional agreements to ensure continued data protection
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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