Antibiotic Treatment foLlowing Surgical drAinage of Perianal abScess; the ATLAS Trial, a Double-blind, Placebo-controlled, Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 298
- 试验地点
- 11
- 主要终点
- Perianal fistula at 1 year follow up
研究概览
简要总结
Rationale:
Perianal fistula is a burdening disease with an annual prevalence of 2/100.000 in the Dutch population. More than 90% of crypto-glandular fistulas originate from anorectal abscess. Despite adequate drainage of anorectal abscess up to 83% recurs or results in an anal fistula, the majority developing within 12 months. Up till now it is not common practice to routinely administer prophylactic antibiotics to prevent anal fistula development.\
Objective:
The objective of this trial is to establish if adding antibiotic treatment to surgical drainage of perianal abscess results in less perianal fistulas.
Study design:
The study concerns a double-blind, placebo-controlled, randomized, multicenter trial with treatment of perianal abscess by surgical drainage alone or combined with antibiotic treatment. Patients will be accrued by all participating clinics. The design involves allocation of all appropriate consecutive patients with a primary occurrence of perianal abscess to surgical drainage followed by either antibiotics or placebo. Data will be analyzed on 'intention to treat' basis in case patients are not subjected to the randomized treatment modality.
Study population:
Men and women of 18 years and older who present for the first time with a perianal abscess.
Intervention (if applicable): The antibiotic group receives 7 days of oral metronidazole (500 mg every eight hours) and ciprofloxacin (500 mg every twelve hours) in addition to surgical drainage. The other group receives surgical drainage and postoperatively identical placebo tablets.
Main study parameters/endpoints:
Primary outcome measure is development of a perianal fistula. Secondary outcome measures are quality of life at 12 months measured with the EQ-5D-5L with Dutch rating. Further: in-hospital direct and indirect costs and out-of hospital postoperative costs, need of repeated drainage, patient related outcome (PRO) and clinical outcome measures.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
For this study, patients are asked to take part in a study comparing the addition of antibiotic treatment to surgical drainage of perianal abscess. Patients will not be burdened by extra hospital visits. At baseline participants will complete PRO questionnaires. Also at 1 week and 3, 6 and 12 months participants will fulfill the PRO questionnaires. These will be send to them by email and will take approximately 10 minutes each time.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Patiënt, clinician and investigators are all blinded
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
- •Men and women aged 18 years or older
- •Eligible for e-mail questionnaires
- •Sufficient understanding of the Dutch written language (reading and writing)
- •Obtained written informed consent
排除标准
- •A coexistent anorectal fistula
- •Secondary or recurrent anorectal abscess
- •Presence of an internal fistula opening
- •Any additional surgical procedure performed during the same session
- •Previous (peri)anal surgery
- •Inflammatory bowel disease
- •History of radiation of the pelvic area
- •Anorectal malignancy
- •Immunodeficiency
- •Kidney failure (eGFR <30ml/min)
- •Valvular heart disease
- •Pregnancy or lactation
- •Postoperative antibiotic prophylaxis indicated for another reason
- •Immunosuppressive medication at the time of surgery
- •Allergy to metronidazole or ciprofloxacin
- •Not able or trouble with swallowing pills
- •Concomitant use of:
- •Tizanidine, theophylline, clozapine, olanzapine, pirfenidone, carbamazepine, agomelatine (these are all CYP1A2 substrates, ciprofloxacin is an inhibitor)
- •Amiodarone, erythromycin, sotalol, azithromycin, citalopram, escitalopram, flecainide, fluconazole, haloperidol >5mg/day, methadone, ondansetron (concerning prolonged QT interval in combination with ciprofloxacin)
- •Lithium (can cause toxic levels with metronidazole)
- •Lopinavir/ritonavir, ritonavir capsules, temsirolimus, disulfiram (antabuse), mebendazole (can cause serious side effects, confusion and psychosis in combination with metronidazole)
- •Corticosteroids (in combination with ciprofloxacin higher risk of tendinitis and tendon rupture).
研究组 & 干预措施
Placebo
Placebo tabletes
干预措施: Placebo (Drug)
Antibiotic treatment
Two kinds of antibiotics: Ciprofloxacine 500mg 2dd & Metronidazole 500mg 3dd
干预措施: Ciprofloxacin 500 mg (Drug)
Antibiotic treatment
Two kinds of antibiotics: Ciprofloxacine 500mg 2dd & Metronidazole 500mg 3dd
干预措施: Metronidazole 500 mg (Drug)
结局指标
主要结局
Perianal fistula at 1 year follow up
时间窗: 1 year
A perianal fistula is diagnosed based on findings from physical examination or by a telephone call after 12 months were the doctor asks for symptoms as serosanguinous discharge and pain. An external opening with or without serosanguilent discharge is considered a fistula. In case of doubt an endoanal ultrasonography or MRI is performed. So: yes/no fistula (dichotomous parameter)
次要结局
- Recurrent abscess(1 year)
- Need of repeated drainage(1 year)
- PROMs(1 year)
- Quality of life at 12 months measured with the EQ-5D-5L with Dutch rating.(1 year)
- In-hospital direct and indirect costs and out-of hospital posteroperative costs(1 year)
- Day of discharge from hospital(1 year)
- Duration of absence from work(1 year)
- Postoperative complications(1 year)
研究者
dr. IJM Han-Geurts
Principal investigator
Proctos Kliniek