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| Name | Class |
|---|---|
| Uppsala University | OTHER |
| Västra Götalandsregionen | OTHER |
| Göteborg University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drainless Group (Intervention) | Experimental | 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. |
|
| Standard Drain Group (Control) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active wound drainage (Standard of Care) | Procedure | An active suction drain is placed in the surgical bed before wound closure, which is the current established clinical practice for parotidectomy in Sweden. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | From the day of surgery up to 7 weeks postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the first postoperative day up to 6 months |
| Postoperative facial nerve function. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karl Sandström, MD, PhD | Contact | +46 76 113 29 52 | karl.sandstrom@akademiska.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska university hospital | Recruiting | Stockholm | Sweden | |||
| NÄL |
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
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| ID | Term |
|---|---|
| D010307 | Parotid Neoplasms |
| D011183 | Postoperative Complications |
| D049291 | Seroma |
| D006406 | Hematoma |
| ID | Term |
|---|---|
| D012468 | Salivary Gland Neoplasms |
| D009062 | Mouth Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Omission of active wound drain | Procedure | 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. |
|
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 | Subjective and objective assessment of gustatory sweating (Frey's syndrome). | 6 months postoperatively. |
| 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. | 7 weeks, and 6 months postoperatively |
| Postoperative length of stay | 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) | 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 |
| Recruiting |
| Trollhättan |
| Sweden |
| Uppsala University Hospital, Department of Otorhinolaryngology | Recruiting | Uppsala | Sweden |
|
| D009369 |
| Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D010305 | Parotid Diseases |
| D012466 | Salivary Gland Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007249 | Inflammation |
| D006470 | Hemorrhage |