Swedish National Parotidectomy Study (SNaPs): Drainless Versus Standard Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUppsala University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Active wound drainage (Standard of Care)
Procedure/SurgeryAn active suction drain is placed in the surgical bed before wound closure, which is the current established clinical practice for parotidectomy in Sweden.
Omission of active wound drain
Procedure/SurgeryThe 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.
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: Drainless Group (Intervention)Experimental treatment 1 intervention
Group B: Standard Drain Group (Control)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cumulative incidence of early postoperative complications requiring intervention
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).
Time frame
From the day of surgery up to 7 weeks postoperatively.Secondary outcomes
1
Requirement for inpatient hospital care after the day of surgery.
Evaluation of the number of participants requiring unplanned hospital admission or prolonged stay related to the surgical procedure.
Time frame
From the first postoperative day up to 6 months2
Postoperative facial nerve function.
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).
Time frame
Baseline (preoperative), at discharge, at 7 weeks, and at 6 months3
Incidence of Frey's syndrome
Subjective and objective assessment of gustatory sweating (Frey's syndrome).
Time frame
6 months postoperatively.4
Health-related quality of life (EQ-5D-5L)
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.
Time frame
7 weeks, and 6 months postoperativelySponsors and contacts
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Uppsala University Hospital
Lead sponsor
Uppsala University
Collaborator
Västra Götalandsregionen
Collaborator
Göteborg University
Collaborator
Source ClinicalTrials.gov