Partial or Total Surgical Removal of Palatal Tonsils to Change Quality of Life for Adults With Chronic or Recurrent Tonsillitis: Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 147
- 试验地点
- 12
- 主要终点
- Tonsillectomy Outcome Inventory -14 (TOI-14) follow-up score
研究概览
简要总结
Tonsil surgery is common in adults with recurrent or chronic tonsillitis. The surgical techniques include either partial or total surgical removal of the palatal tonsils (tonsillotomy, TT, and tonsillectomy, TE, respectively). The aim of this study is to find out, whether tonsil surgery improves the quality of life in these patients and whether the lighter TT is as effective as TE. Our main outcome is the disease-specific Tonsillectomy Outcome Inventory-14 (TOI-14) quality of life questionnaire score at 6 months follow-up.
详细描述
Rationale
Surgical removal of palatal tonsils is among the most common ear, nose and throat operations in adults in Finland. The vast majority of these operations are done for recurrent and chronic tonsillitis. Internationally accepted guidelines for the treatment of these diseases are lacking and the indications for tonsil surgery are practice-based rather than evidence-based. The choice of the surgical technique further confuses the picture. The traditional surgical technique has been the total removal of tonsils (tonsillectomy, TE). The relatively recent introduction of partial resection of tonsils, namely tonsillotomy (TT), is suggested to have the benefits of less postoperative pain and smaller risk of post-operative hemorrhage as compared to TE. The relative efficacy of these two techniques to alleviate infective tonsillar diseases is still unclear.
Objectives
The main aim of this study is to obtain reliable evidence on, whether tonsil surgery improves the quality of life in adult patients suffering from recurrent or chronic tonsillitis, and whether the lighter TT would be as effective as TE. We will also compare the scores of a generic quality of life questionnaire as well as several other subjective and objective beneficial and harmful outcomes between the groups.
Methods
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)
盲法说明
Patients in active arms don't know if they are in tonsillectomy or tonsillotomy group
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Tonsillectomy Outcome Inventory -14 (TOI-14) follow-up score
时间窗: At the end of five to six months follow-up
TOI-14 is a disease-specific quality of life questionnaire for throat related symptoms in adults. TOI-14 summary scores vary between 0 and 100 with higher values indicating poorer quality of life. Analysis is described in the Detailed Description section.
次要结局
- Days with bleeding(At the end of five to six months follow-up)
- Days with tonsil stones(At the end of five to six months follow-up)
- Days with throat pain(At the end of five to six months follow-up)
- Days with halitosis(At the end of five to six months follow-up)
- Days with dexketoprofen(At the end of five to six months follow-up)
- Days with acetaminophen(At the end of five to six months follow-up)
- Days with absence from work(At the end of five to six months follow-up)
- Days with oxycodone/naloxone(At the end of five to six months follow-up)
- Medical visits(At the end of five to six months follow-up)
- Antibiotic courses(At the end of five to six months follow-up)
- Adverse effect - tightness/globus(At the end of five to six months follow-up)
- Adverse effect - voice problems(At the end of five to six months follow-up)
- Adverse effect - jaw problems(At the end of five to six months follow-up)
- Adverse effect-postoperative bleeding(At the end of five to six months follow-up)
- Adverse effect - postoperative pain(At the end of five to six months follow-up)
- Adverse effect - postoperative infection(At the end of five to six months follow-up)
- Adverse effect -anesthetic complication(At the end of five to six months follow-up)
- Adverse effect - dental injury(At the end of five to six months follow-up)
- 36-Item short Form Survey (SF-36, RAND-36) follow-up score(At the end of five to six months follow-up)
- Proportion benefiting(At the end of five to six months follow-up)
研究者
Olli-Pekka Alho, MD
Professor, MD
Oulu University Hospital