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临床试验/NCT07598201
NCT07598201尚未招募不适用

Recovery From Tonsil Surgery (FINITE-2). A Randomized, Controlled, Single-blinded Trial Exploring the Recovery and Effectiveness of Two Tonsil Surgery Techniques in Adults.

Turku University Hospital0 个研究点目标入组 90 人开始时间: 2026年6月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
90

研究概览

简要总结

The goal of this study is to optimize the duration of sick leave and the usage of opioids following partial tonsillar surgery in adults by comparing the recovery after extracapsular tonsillectomy (ECTE) with recovery after intracapsular tonsillectomy (ICTE). An additional objective is to confirm that ICTE is as effective as ECTE when comparing TOI-14 scores after 12 months post-operatively.

The main questions the study aims to answer are:

  • Is 10 days sick leave enough after partial tonsillectomy (ICTE)?
  • Are opioids needed at all after partial tonsillectomy (ICTE)?
  • Is ICTE as effective as ECTE when comparing TOI-14 symptom scores after 12 months from the surgery?

Adult patients who are scheduled to tonsil surgery are randomised into 2 groups: ICTE and ECTE. Patients are blinded. Postoperatively they will answer structured questions about the recovery and effectiveness of the surgery. The last follow up survey is 60 months after the surgery.

详细描述

General Study Outline

  • Adult patients scheduled for day-surgery tonsillectomy based on out-patient clinic evaluation done by ENT specialists will be recruited starting January 2026. A participant information sheet will be given to these patients.
  • If the patient is scheduled to tonsil surgery by referral letter, the participant information sheet will be sent along with other materials related to the surgery.
  • Research doctor will contact the patient by phone to inquire about their interest in participating the study and to assess the eligibility. If the patient expresses interest and meets the inclusion criteria more detailed information will be provided by phone. The number of patients meeting the inclusion criteria, those who are invited to participate, and those who provide informed consent will be recorded. If the patient is eligible and will participate the study, a consent will be obtained. With their written informed consent, all patients will be registered into a common electronic database (Research Electronic Data Capture, REDCap 10.6.9 2021 Vanderbilt University, Nashville, Tennessee, USA) at the University of Turku and the baseline patient-reported outcome measure questionnaires will be sent by e-mail (RedCap).
  • On the morning of the surgery baseline data will be checked and patients will be randomized to undergo either intracapsular tonsillectomy using coblation instrument or extracapsular tonsillectomy using monopolar, both day surgery. 10 days of sick-leave will be written to all patients. Non-steroidal anti-inflammatory drugs (NSAIDs) and paracetamol are advised to use as analgesics. Rescue opioid is prescribed.
  • On the day 7 after the surgery study coordinator will call each patient and ask structured questions.
  • Days 0-14 after surgery, patients will fill in data about recovery and usage of analgesics. Data is recorded in RedCap.
  • Follow-up surveys via RedCap will be sent after 1, 12, 24 and 60 months after the surgery.

Patients and Methods Eligibility criteria The indication for tonsil surgery will be due to clinical condition. The patient is eligible for this study if the indication for the surgery is: at least 3 tonsillitis during the last 12 months or chronic tonsillitis, which is defined as a prolonged tonsil-derived throat pain and at least one symptom or sign indicating that symptoms are tonsil-related (ie. enlarged tonsils, tonsillar exudates, halitosis, tonsillar stones, enlarged and tender submandibular lymph nodes). Additionally, these symptoms should have affected patient's everyday life for at least 3 months. The diagnosis and the decision of the tonsil surgery along with a general ORL examination will be made by otorhinolaryngologist at a visit to out-patient clinic. Surgery will be scheduled according to queue situation.

Recruitment Research doctors will recruit patients from the tonsillectomy queue via phone call. Furthermore, inclusion and exclusion criteria will be verified on the phone and an assessment for eligibility form filled in and recorded in RedCap and on the servers of The wellbeing services county of Southwest Finland (VARHA). Sufficient information is given to the patient to make an informed decision, both verbally and in written form. Patients will receive a participant information sheet to read before giving consent. They will be given the opportunity to ask questions about the research. Participation in the study is voluntary for the patient. All patients called are considered assessed for eligibility and the data will be stored anonymously. Additionally, all non-eligible patients, along with the reasons for ineligibility, will be documented. Those who are eligible but choose not to participate will also be recorded anonymously. Finally, a study group will be formed consisting of eligible patients who have provided written consents.

Consent and registration A written informed consent will be collected from all study participants before any study procedures. The ENT surgeon who operates the patient will collect the written consent before the surgery in the morning. Clinical and other study related data will be collected systematically into a university provided and approved common electronic database (Research Electronic Data Capture, REDCap 10.6.9 2021 Vanderbilt University, Nashville, Tennessee, USA) at the University of Turku. Personal data and baseline characteristics will be recorded in REDCap.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-65 years
  • Recurrent or chronic tonsillitis (see above)
  • Indication for surgical treatment
  • Eligible for day care surgery

排除标准

  • Peritonsillar abscess less than month ago
  • Previous palatine tonsil surgery (excluding small incision or biopsy)
  • Current or positive history of a malignant disease
  • Anticoagulant medication
  • Contraindication to non-steroidal anti-inflammatory drugs (NSAID) or paracetamol
  • Other significant co-morbidity
  • Other contraindications determined by the investigator

研究者

申办方类型
Other Gov
责任方
Sponsor

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