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

2026년 6월 2일 업데이트: Karl Sandström, Uppsala University Hospital

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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

600

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 스웨덴
      • Stockholm, 스웨덴
        • 모병
        • Karolinska University Hospital
      • Trollhättan, 스웨덴
        • 모병
        • NÄL
      • Uppsala, 스웨덴
        • 모병
        • Uppsala University Hospital, Department of Otorhinolaryngology
        • 연락하다:

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
절차: 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.
활성 비교기: 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.
절차: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Cumulative incidence of early postoperative complications requiring intervention
기간: 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).
From the day of surgery up to 7 weeks postoperatively.

2차 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Uppsala University Hospital

협력자

Uppsala University
Göteborg University
Västra Götalandsregionen

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 5월 6일

기본 완료 (추정된)

2030년 12월 1일

연구 완료 (추정된)

2032년 12월 1일

연구 등록 날짜

최초 제출

2026년 5월 19일

QC 기준을 충족하는 최초 제출

2026년 5월 26일

처음 게시됨 (실제)

2026년 6월 2일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 4일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 2일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2025-07555-01

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

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

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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