Parotid Neoplasms, Post-operative Complications, Seroma as Procedural Complication
Conditions
Keywords
Parotidectomy, Surgical drainage, Wound drains, Postoperative complications, Seroma, Hematoma, Randomised controlled trial, Non-inferiority, Salivary gland surgery, Quality of life
Brief summary
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.
Interventions
PROCEDUREActive 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.
PROCEDUREOmission 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.
Sponsors
Uppsala University Hospital
Uppsala University
Västra Götalandsregionen
Göteborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of early postoperative complications requiring intervention | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Requirement for inpatient hospital care after the day of surgery. | 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. |
| Postoperative facial nerve function. | 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). |
| Incidence of Frey's syndrome | 6 months postoperatively. | Subjective and objective assessment of gustatory sweating (Frey's syndrome). |
| Health-related quality of life (EQ-5D-5L) | 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. |
| Postoperative length of stay | 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. |
| Symptom-specific outcomes (SwPOI-8) | 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. |
Countries
Sweden
Contacts
CONTACTKarl Sandström, MD, PhD
Outcome results
None listed