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

Официальное название

A Prospective, Randomized, Multicenter Non-Inferiority Trial Evaluating the Safety of Parotidectomy Without Active Surgical Drainage (Svenska Nationella Parotisstudien)

Обзор

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.

Вмешательства

• Процедура 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.
• Процедура 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.

Первичные конечные точки

• Cumulative incidence of early postoperative complications requiring intervention [Срок оценки: From the day of surgery up to 7 weeks postoperatively.]

Вторичные конечные точки (6)

• Requirement for inpatient hospital care after the day of surgery. [Срок оценки: From the first postoperative day up to 6 months]
• Postoperative facial nerve function. [Срок оценки: Baseline (preoperative), at discharge, at 7 weeks, and at 6 months]
• Incidence of Frey's syndrome [Срок оценки: 6 months postoperatively.]
• Health-related quality of life (EQ-5D-5L) [Срок оценки: 7 weeks, and 6 months postoperatively]
• Postoperative length of stay [Срок оценки: Through initial hospital discharge, an average of 1.5 days, assessed up to 7 weeks.]
• Symptom-specific outcomes (SwPOI-8) [Срок оценки: 7 weeks and 6 months postoperatively]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Швеция · 3 центра

• Karolinska university hospital — Stockholm
• NÄL — Trollhättan
• Uppsala University Hospital, Department of Otorhinolaryngology — Uppsala

Идентификаторы

NCT: NCT07620184 · 2025-07555-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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