跳至主要内容
临床试验/NCT04998513
NCT04998513撤回不适用

Medical Versus Surgical Treatment for Peritonsillar Abscesses: a Pilot Study for a Randomized, Multi-institutional Pragmatic Superiority Trial

Nova Scotia Health Authority0 个研究点开始时间: 2022年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
撤回
主要终点
Retention rates

研究概览

简要总结

Peritonsillar abscesses are major infections around the tonsils. The abscess is a collection of pus that can cause a large amount of pain and discomfort, which can result in trouble swallowing and drinking. Peritonsillar abscesses must be treated because they can spread to other areas in the throat and neck, which can cause difficulty breathing, can even spread throughout the rest of the body.

Over the years, many different treatments have been used for peritonsillar abscesses. In the past, the entire tonsil was removed in the operating room while the patient was asleep. This surgery can cause a large amount of bleeding, and so now smaller surgeries are performed while the patient is awake. Small needles are put through the open mouth and into the abscess to drain it. As well, a small cut can be made to drain the infection. These last two treatments cause less problems than removing the whole tonsil, but there are still risks. The surgeries are uncomfortable for patients and they can cause anxiety and fear. There are also large blood vessels nearby that can be injured.

In the last few years, treatment of peritonsillar abscesses without surgery has been studied. Patients receive strong antibiotics and anti-inflammatories (known as steroids) and they may not need surgery. It is not yet known if this treatment works as well as surgery. In order to figure this out, research must look at both options compared against each other in a large study with many patients.

However, large research studies require a lot of planning, and so smaller studies are helpful to figure out if the larger study is even possible. The current study would be a small trial to plan for a larger study later on.

Patients will be randomly treated with either medications alone or with surgery. The main part of the study will look at issues with planning the future study, such as how long it takes to fill out forms, how many missing results there are at the end of the study, and how patients and doctors feel about taking part in the research study. The future large study will look at how well the treatment options reduce pain, how fast patients are able to swallow normally again, how often patients need to change treatments, and whether there are differences in quality of life with the treatment options. Because these things will be looked at in detail in the future large study, the investigators will also look at them during this small planning study, but the investigators will not be able to tell for certain which treatment is better until the large study is completed.

The results of this study are important for planning and performing the larger study, and they are important for getting future funding to do that study. Large studies are very expensive, and major funding organizations, such as the Canadian Institutes of Health Research, look for this early data when deciding who should get funding. The results of both this pilot study and the future larger study could be practice changing for how peritonsillar abscesses are treated, and will benefit both Nova Scotians and potentially the rest of world.

详细描述

Peritonsillar abscesses (PTA) are the most common deep neck space infection, and are amongst the most common on-call emergency consultations for otolaryngologists. The PTA is a collection of pus in the peritonsillar space resulting from untreated tonsillitis and pharyngitis. The bacteria responsible for PTA formation have fluctuated, and largely include a multitude of both anaerobic and aerobic species1,2.

Previous studies have demonstrated world-wide incidences of 10 to 40 per 100,000 people, and recent Canadian evidence has shown agreement2. Despite the tendency to be relatively benign, PTA's have potential for spread to other deep neck spaces, such as the parapharyngeal space, and can cause sepsis and airway obstruction3. The possibility of these sequelae necessitates prompt treatment of any PTA.

The diagnosis of PTA is sometimes difficult, and specific criteria are lacking. The use of radiological imaging varies geographically, and the diagnosis typically relies on clinical acumen3. However, it should be noted that the clinical spectrum between tonsillitis, peritonsillar cellulitis, and PTA can be difficult to differentiate4,5. There is no agreed upon guideline for the diagnosis and management of PTA, and current practices are unknown. Our group is currently investigating this evidence gap (study ongoing).

Management of PTA has changed over many years. Traditional approaches had previously found surgical intervention essential for treating abscesses, including combinations of needle aspiration, incision and drainage, and immediate tonsillectomy. In this regard, incision and drainage has been found to be the best option in regard to both reducing recurrence and avoiding complications such as post-tonsillectomy hemorrhage6. While surgical interventions for PTA are commonly performed procedures, they are not without risk, including the possibility of significant hemorrhage from carotid artery injury, elevated pain levels, and emotional distress7.

Given these risks, and the often-limited availability of specialist access, other authors have questioned the need for the surgical intervention of PTA. Proponents of this new approach argue that medical treatment alone results in lesser pain and faster return to normal oral intake and daily living, without an increase in treatment failure or PTA associated sequelae. Furthermore, medical treatment alone helps satisfy tenants of the Canada Health Act. A large proportion of Canada's population is rural8. While emergency surgical treatment of PTA is generally accessible through costly transportation measures such as long-distance driving, ambulance transfer, or air lift, a substantial portion of the rural population would benefit from avoidance of this transportation altogether. Regardless of its implication for policy change and accessibility, medical treatment may serve to improve patient quality of life (QOL) and patient oriented outcomes by reducing travel time and empowering non-otolaryngologist providers to competently intervene.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Outcomes Assessor)

盲法说明

Analysts will be masked as to the study arm participants are randomized to.

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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Medical Management Alone Arm

Active Comparator

Antibiotics, steroids, fluids

干预措施: Medical Management Alone Arm (Drug)

Surgical Arm

Active Comparator

Incision and drainage

干预措施: Surgical Arm (Procedure)

结局指标

主要结局

Retention rates

时间窗: 1 month

The number of patients completing the required follow-ups will be recorded

Compliance

时间窗: 1 month

The number of completed NPS and analgesia diaries will be recorded

Recruitment rate

时间窗: 1 month

The number of eligible patients screened, regardless of participation, will be recorded and compared to the number of participating patients

次要结局

  • Burden of study involvement of both participants and investigators(1 month)

研究者

申办方类型
Other
责任方
Sponsor

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