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Swedish National Parotidectomy Study (SNaPs): Drainless Versus Standard Surgery (SNaPs)

2 juni 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

600

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Zweden
      • Stockholm, Zweden
        • Werving
        • Karolinska University Hospital
      • Trollhättan, Zweden
        • Werving
        • NÄL
      • Uppsala, Zweden
        • Werving
        • Uppsala University Hospital, Department of Otorhinolaryngology
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Procedure: Omission of active wound drain
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.
Actieve vergelijker: 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.
Procedure: Active wound drainage (Standard of Care)
An active suction drain is placed in the surgical bed before wound closure, which is the current established clinical practice for parotidectomy in Sweden.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Cumulative incidence of early postoperative complications requiring intervention
Tijdsspanne: From the day of surgery up to 7 weeks postoperatively.
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).
From the day of surgery up to 7 weeks postoperatively.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Requirement for inpatient hospital care after the day of surgery.
Tijdsspanne: From the first postoperative day up to 6 months
Evaluation of the number of participants requiring unplanned hospital admission or prolonged stay related to the surgical procedure.
From the first postoperative day up to 6 months
Postoperative facial nerve function.
Tijdsspanne: Baseline (preoperative), at discharge, at 7 weeks, and at 6 months
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).
Baseline (preoperative), at discharge, at 7 weeks, and at 6 months
Incidence of Frey's syndrome
Tijdsspanne: 6 months postoperatively.
Subjective and objective assessment of gustatory sweating (Frey's syndrome).
6 months postoperatively.
Health-related quality of life (EQ-5D-5L)
Tijdsspanne: 7 weeks, and 6 months postoperatively
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.
7 weeks, and 6 months postoperatively
Postoperative length of stay
Tijdsspanne: Through initial hospital discharge, an average of 1.5 days, assessed up to 7 weeks.
Total number of days spent in hospital following the surgical procedure.
Through initial hospital discharge, an average of 1.5 days, assessed up to 7 weeks.
Symptom-specific outcomes (SwPOI-8)
Tijdsspanne: 7 weeks and 6 months postoperatively
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.
7 weeks and 6 months postoperatively

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Uppsala University Hospital

Medewerkers

Uppsala University
Göteborg University
Västra Götalandsregionen

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

6 mei 2026

Primaire voltooiing (Geschat)

1 december 2030

Studie voltooiing (Geschat)

1 december 2032

Studieregistratiedata

Eerst ingediend

19 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

26 mei 2026

Eerst geplaatst (Werkelijk)

2 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

2 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 2025-07555-01

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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