Non-antibiotic Management in Acute Uncomplicated Diverticulitis: Randomized Open Label-controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 入组人数
- 556
- 试验地点
- 1
研究概览
简要总结
Diverticulitis is a common condition that causes swelling and pain in part of the colon (the large intestine). Doctors classify it as "mild" when there are no serious complications.
For many years, doctors in the United States have treated mild diverticulitis with antibiotics. New studies from Europe suggest that many people with mild diverticulitis may not need antibiotics and can get better with just pain medicines. But this approach has not been tested in the United States, where antibiotics are still the standard treatment.
The goal of this clinical trial is to find out if people with mild diverticulitis can be safely treated at home without antibiotics. The main questions it aims to answer are:
- Are people treated without antibiotics admitted to the hospital more often than people treated with antibiotics?
- Do people treated without antibiotics have more emergency room visits, worsening of their disease, or need for surgery?
Researchers will compare two groups of people who come to the emergency department with mild diverticulitis to see if treatment without antibiotics is as safe as treatment with antibiotics.
Participants will:
- Be sent home with pain medicines (ibuprofen and acetaminophen) only, or with pain medicines plus an antibiotic taken by mouth for 7 days
- Follow a liquid diet and slowly return to normal food as they feel better
- Come back to clinic for a check-up at 1 to 2 weeks
- Answer phone calls about their health at 4 weeks, 3 months, and 6 months
详细描述
BACKGROUND AND RATIONALE
Current guidelines from the American Gastroenterological Association (AGA) and the American Society of Colon and Rectal Surgeons (ASCRS) recommend selective rather than routine antibiotic use for acute uncomplicated diverticulitis. These recommendations are based primarily on four randomized trials conducted outside the United States: Antibiotic Therapy of Acute Uncomplicated Colonic Diverticulitis study (AVOD, Sweden, 2012 NCT01008488); Diverticulitis: Antibiotics or Close Observation? study (DIABOLO, Netherlands, 2017, NCT01111253); Selective Treatment with Antibiotics for Non-complicated Diverticulitis study (STAND, New Zealand/Australia, 2021, Australian clinical trials registration number: 12615000249550); and the Randomized Clinical Trial to Compare the Treatment of Mild Acute Diverticulitis With or Without Antibiotics (DINAMO) study (Spain, 2021, NCT02785549). Of these, only DINAMO evaluated a fully outpatient approach. No equivalent trial has been conducted in the United States, where antibiotic therapy remains routine for this patient population. Differences in patient demographics, comorbidity burden, healthcare delivery systems, and outpatient follow-up infrastructure may influence the generalizability of prior findings to U.S. populations, sustaining clinical equipoise.
HYPOTHESIS
In adults presenting to the Emergency Department (ED) with acute uncomplicated diverticulitis (modified Hinchey 0 or 1a) and meeting predefined low-risk criteria, outpatient management without antibiotics is non-inferior to standard outpatient antibiotic therapy with respect to diverticulitis-related hospitalization within 6 months.
STUDY DESIGN OVERVIEW
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
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Left-sided diverticulitis, primary or recurrent
- •Signs of diverticulitis on CT-confirmed Hinchey (0 or 1a based on CT final report)
- •White Blood Cell (WBC) count <15,000mm^3
- •Controlled symptoms in the ED (i.e., Pain score <5 on VAS scale, tolerating PO intake, no fever)
排除标准
- •Signs of complicated diverticulitis on CT with abscess, fistula, free air, Micro perforation, or signs of other diagnosis on CT Abdomen and pelvis
- •Inflammatory bowel disease
- •American Society for Anesthesiologists (ASA) physical status classification of >=3
- •Immunocompromised patient; (i.e., haematological malignancies, AIDS patients with low CD4+ counts, transplantation, chemotherapy, splenectomy, long-term corticosteroid use and genetic disorders such as severe combined immunodeficiency
- •Pregnancy
- •Ongoing antibiotic therapy or in the previous 2 weeks
- •High fever, affected general condition, peritonitis or sepsis
- •Subjects who do not have the capacity to consent
研究组 & 干预措施
Standard Antibiotic Therapy
Participants randomized to this arm will be discharged from the Emergency Department with standard outpatient antibiotic therapy in addition to symptomatic treatment. The regimen consists of oral amoxicillin/clavulanate 875/125 mg every 12 hours for 7 days, plus oral ibuprofen 400 mg every 8 hours and/or oral acetaminophen 1 g every 8 hours for symptom control, a liquid diet advancing as tolerated, and standardized return precautions. Participants with a documented or self-reported penicillin or beta-lactam allergy will receive oral ciprofloxacin 500 mg every 12 hours plus oral metronidazole 500 mg every 8 hours for 7 days instead of amoxicillin/ clavulanate. Participants will receive a patient handout with medication instructions, follow-up schedule, and a dedicated contact number for questions or adverse events.
干预措施: Amoxicillin-clavulanate (Drug)
No-Antibiotic Group
Participants randomized to this arm will be discharged from the Emergency Department with symptomatic treatment only, without antibiotics. The regimen consists of oral ibuprofen 400 mg every 8 hours and/or oral acetaminophen 1 g every 8 hours for symptom control, a liquid diet advancing as tolerated, and standardized return precautions. Participants will receive a patient handout with medication instructions, follow-up schedule, and a dedicated contact number for questions or adverse events.
干预措施: Symptomatic treatment (ibuprofen and acetaminophen) (Drug)
Standard Antibiotic Therapy
Participants randomized to this arm will be discharged from the Emergency Department with standard outpatient antibiotic therapy in addition to symptomatic treatment. The regimen consists of oral amoxicillin/clavulanate 875/125 mg every 12 hours for 7 days, plus oral ibuprofen 400 mg every 8 hours and/or oral acetaminophen 1 g every 8 hours for symptom control, a liquid diet advancing as tolerated, and standardized return precautions. Participants with a documented or self-reported penicillin or beta-lactam allergy will receive oral ciprofloxacin 500 mg every 12 hours plus oral metronidazole 500 mg every 8 hours for 7 days instead of amoxicillin/ clavulanate. Participants will receive a patient handout with medication instructions, follow-up schedule, and a dedicated contact number for questions or adverse events.
干预措施: Symptomatic treatment (ibuprofen and acetaminophen) (Drug)
Standard Antibiotic Therapy
Participants randomized to this arm will be discharged from the Emergency Department with standard outpatient antibiotic therapy in addition to symptomatic treatment. The regimen consists of oral amoxicillin/clavulanate 875/125 mg every 12 hours for 7 days, plus oral ibuprofen 400 mg every 8 hours and/or oral acetaminophen 1 g every 8 hours for symptom control, a liquid diet advancing as tolerated, and standardized return precautions. Participants with a documented or self-reported penicillin or beta-lactam allergy will receive oral ciprofloxacin 500 mg every 12 hours plus oral metronidazole 500 mg every 8 hours for 7 days instead of amoxicillin/ clavulanate. Participants will receive a patient handout with medication instructions, follow-up schedule, and a dedicated contact number for questions or adverse events.
干预措施: Ciprofloxacin plus metronidazole (Drug)