Swedish National Parotidectomy Study (SNaPs): Drainless Versus Standard Surgery (SNaPs)
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.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Karl Sandström, MD, PhD
- 电话号码：+46 76 113 29 52
- 邮箱：karl.sandstrom@akademiska.se
学习地点
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Stockholm、瑞典
- 招聘中
- Karolinska University Hospital
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Trollhättan、瑞典
- 招聘中
- NÄL
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Uppsala、瑞典
- 招聘中
- Uppsala University Hospital, Department of Otorhinolaryngology
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接触：
- Karl Sandström, MD, PhD
- 电话号码：+46 76 113 29 52
- 邮箱：karl.sandstrom@akademiska.se
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
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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.
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有源比较器：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.
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An active suction drain is placed in the surgical bed before wound closure, which is the current established clinical practice for parotidectomy in Sweden.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Cumulative incidence of early postoperative complications requiring intervention
大体时间：From the day of surgery up to 7 weeks postoperatively.
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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).
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From the day of surgery up to 7 weeks postoperatively.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Requirement for inpatient hospital care after the day of surgery.
大体时间：From the first postoperative day up to 6 months
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Evaluation of the number of participants requiring unplanned hospital admission or prolonged stay related to the surgical procedure.
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From the first postoperative day up to 6 months
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Postoperative facial nerve function.
大体时间：Baseline (preoperative), at discharge, at 7 weeks, and at 6 months
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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).
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Baseline (preoperative), at discharge, at 7 weeks, and at 6 months
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Incidence of Frey's syndrome
大体时间：6 months postoperatively.
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Subjective and objective assessment of gustatory sweating (Frey's syndrome).
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6 months postoperatively.
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Health-related quality of life (EQ-5D-5L)
大体时间：7 weeks, and 6 months postoperatively
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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.
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7 weeks, and 6 months postoperatively
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Postoperative length of stay
大体时间：Through initial hospital discharge, an average of 1.5 days, assessed up to 7 weeks.
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Total number of days spent in hospital following the surgical procedure.
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Through initial hospital discharge, an average of 1.5 days, assessed up to 7 weeks.
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Symptom-specific outcomes (SwPOI-8)
大体时间：7 weeks and 6 months postoperatively
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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.
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7 weeks and 6 months postoperatively
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2025-07555-01
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