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

2 juni 2026 uppdaterad av: 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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

600

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Sverige
      • Stockholm, Sverige
        • Rekrytering
        • Karolinska University Hospital
      • Trollhättan, Sverige
        • Rekrytering
        • NÄL
      • Uppsala, Sverige
        • Rekrytering
        • Uppsala University Hospital, Department of Otorhinolaryngology
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Hälsovårdsforskning
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Procedur: 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.
Aktiv komparator: 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.
Procedur: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Cumulative incidence of early postoperative complications requiring intervention
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Requirement for inpatient hospital care after the day of surgery.
Tidsram: 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.
Tidsram: 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
Tidsram: 6 months postoperatively.
Subjective and objective assessment of gustatory sweating (Frey's syndrome).
6 months postoperatively.
Health-related quality of life (EQ-5D-5L)
Tidsram: 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
Tidsram: 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)
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Uppsala University Hospital

Samarbetspartners

Uppsala University
Göteborg University
Västra Götalandsregionen

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

6 maj 2026

Primärt slutförande (Beräknad)

1 december 2030

Avslutad studie (Beräknad)

1 december 2032

Studieregistreringsdatum

Först inskickad

19 maj 2026

Först inskickad som uppfyllde QC-kriterierna

26 maj 2026

Första postat (Faktisk)

2 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 juni 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

2 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2025-07555-01

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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