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临床试验/NCT03326661
NCT03326661Unknown不适用

Peritonsillar Abscess: Aspiration Versus Tonsillectomy a Chaud

Odense University Hospital1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2017年11月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
128
试验地点
1
主要终点
Number of sick-leave days

研究概览

简要总结

Peritonsillar abscess (PTA) has a relatively high incidence of 41 per 100,000/year in Denmark. In spite of that, there is no regional or national consensus on treatment of PTA. Abscess drainage can be done by aspiration, incision or acute tonsillectomy. Several studies show that incision and aspiration are equally successful. The aim for this study is to compare aspiration to acute tonsillectomy (tonsillectomy a chaud) in a RCT study regarding sick-leave days, days of admission, pain, consumption of antibiotics, consumption of painkillers and patients´ self-assessed quality of life.

详细描述

Background Peritonsillar abscess (PTA) is a complication of acute tonsillitis. The condition occurs when the infection spreads from the tonsil to the peritonsillar tissue, resulting in accumulation of pus between the tonsil and the muscles of the throat.

PTA is a common condition with an incidence of 41 per 100.000/year in Denmark. Untreated, PTA may develop into a potentially fatal condition with respiratory problems due to para- or retrofaryngeal abscess or spread of infection to surrounding tissue with necrotizing fasciitis, sepsis and thrombophlebitis of the jugular vein (Lemierres syndrome).

In spite of the high incidence of PTA, there is no regional or national consensus on the treatment of the PTA. There are several methods used for the treating of PTA. Draining of the abscess can be done by puncture and aspiration, incision or immediate abscess tonsillectomy (tonsillectomy a chaud). Additional treatment may consist of antibiotics, analgesics and rehydration. Depending on the general condition patients are either hospitalized for treatment or receive outpatient treatment (aspiration or incision).

Acute surgical intervention (tonsillectomy a chaud) is relevant in children, adults who cannot cooperate to aspiration, if malignancy is suspected in the patient, patients who experience insufficient effect from treatment with aspiration and antibiotics, patients with recurrent PTA or history of recurrent tonsillitis. Based on these criteria, a previous published article reported a relative indication for immediate abscess tonsillectomy in approximately 30% of patients with PTA. The advantage of surgery is that the abscess cavity cannot reform and that, in many cases, antibiotic treatment may be discontinued after the operation. The risk of surgery is primarily post-operative hemorrhage. The hemorrhage rate after immediate abscess tonsillectomy is not significantly higher compared to elective tonsillectomy.

Alternative treatment options are puncture and aspiration of pus or incision and dilatation. Benefits of these treatments are that the patient usually can be treated in outpatient clinics, and avoid surgery in general anesthesia. Good patient compliance is required as well as concomitant antibiotic treatment. Incision treatment has not been found more successful compared to aspiration treatment (NNT=48).

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
None

盲法说明

masking is not possible

入排标准

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

入选标准

  • Peritonsillar abscess

排除标准

  • respiratory distress
  • suspected malignancy
  • previous PTA
  • history of recurrent tonsillitis
  • patients with poor compliance to aspiration

研究组 & 干预措施

Needle aspiration

Active Comparator

Patients treated with aspiration will receive standard antibiotic treatment according to clinical guidelines: Penicillin and metronidazole or Clindamycin alone in case of penicillin allergy. These patients will be treated in the outpatient clinic and will be examined again the day after inclusion. Aspiration will be done if necessary. At this first control visit the clinician will schedule the next visit based on findings.

干预措施: Aspiration (Procedure)

Tonsillectomy a chaud

Active Comparator

Patients treated with tonsillectomy a chaud are admitted for intra-venous treatment with penicillin and metronidazole until surgery. Antibiotic treatment is discontinued after surgery and the patient may be discharged from the hospital the day after surgery.

干预措施: Tonsillectomy a chaud (Procedure)

结局指标

主要结局

Number of sick-leave days

时间窗: 3 months

Days away from job/education or other daily activities due to disease and treatment

次要结局

  • Antibiotic consumption(3 months)
  • Painkiller consumption(3 months)
  • VAS score(3 months)
  • Quality of life and satisfaction with treatment measured by GBI(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christian Heidemann

Principal investigator

Odense University Hospital

研究点 (1)

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