Impact of a Procalcitonin-based Algorithm on Quality of Management in Patients With Uncomplicated Adhesion-related Small Bowel Obstruction Assessed by Textbook Outcome: a Multicenter Cluster-randomized Open-label Controlled Trial. (ALPROC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 488
- 试验地点
- 1
- 主要终点
- proportion of patients achieving textbook outcome
研究概览
简要总结
Adhesion-related small bowel obstruction is a common digestive emergency that can be managed either conservatively or surgically. However, the choice between these two approaches can be difficult due to the absence of specific signs. The objective of this study is to evaluate the clinical impact of a procalcitonin-based algorithm.
详细描述
Acute adhesion-related small bowel obstruction (ASBO) is a common digestive emergency accounting for 1% to 3% of all digestive emergencies. It is associated with a mortality rate of between 2% and 8%, although this figure may be as high as 25% when surgical treatment is delayed. In 2013, the World Society of Emergency Surgery's working group on ASBO suggested two distinct approaches for the management of acute ASBO. Conservative management includes the use of a nasogastric tube (NGT), intravenous administration of fluids, and clinical and biochemical monitoring for 24 to 72 hours or surgical management. However, the efficacy of conservative management in this setting is a subject of debate, as it might delay the decision to perform surgery and increase the frequency of bowel resection (e.g. in the presence of bowel necrosis) or, in contrast, prompt an excessive number of unnecessary laparotomies. The efficacy of water-soluble contrast medium in this setting is also subject to debate, as data from a recent randomized clinical trial including 242 patients (ABOD study) combined with a meta-analysis in 2015 including 990 patients failed to demonstrate any value of gastrografin to reduce the surgery rate and length of stay. Three years ago, our team proposed the use of a marker of bacterial infection and bowel ischemia, procalcitonin (PCT), to help distinguish patients in whom conservative management is likely to be successful from those in whom surgical management was mandatory. Cutoffs of 0.2 µg/L (for failure of conservative management ) and 0.6 µg/L (for need for surgery) accurately identified more than 80% of patients. These cutoffs and data were confirmed in a second independent cohort, and were then used to propose an algorithm for the management of patients with ASBO. In this single-center, retrospective , case-control study, the investigators showed that introduction of this algorithm into patient management reduced i/ the time to surgery with no increase of the surgical management rate; ii/ the length of stay (with a 2-day difference). The investigators propose the hypothesis that introduction of the PCT-based algorithm improves the quality of management of patients with ASBO.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Uncomplicated acute adhesion-related small bowel obstruction (ASBO)
- •Patients able to express consent
- •Signed written informed consent form
- •Covered by national health insurance
排除标准
- •Disease-related criteria:
- •Large bowel obstruction
- •No previous abdominal surgery
- •Signs of peritonitis or strangulation requiring emergency surgery)
- •Obstruction within 4 weeks following previous surgery
- •Ongoing or history of bowel cancer
- •Ongoing or in history of inflammatory bowel disease
- •History of abdominal radiotherapy
- •Active infection
- •Contraindication to contrast-enhanced CT scan
- •Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
- •Pregnancy or breastfeeding
研究组 & 干预措施
algorithm arm
Patient management is based on clinical examination and procalcitonin assessment. From 48 hours after initiation of conservative management in the case of absence of bowel function, operative management (adhesiolysis or bowel resection) will be performed. In the event of discordance between procalcitonin values and clinical examination, management will always be based on clinical examination.
干预措施: algorithm (Diagnostic Test)
no algorithm arm
Patient management is based on clinical examination. Conservative management will be continued for 48 hours in the absence of signs of bowel ischemia (clinical and laboratory assessment other than procalcitonin, as procalcitonin will not be assayed in this arm). Gastrografin will not be used in this arm. Operative management (adhesiolysis or bowel resection) will be performed 48 hours after initiation of conservative management or in the case of absence of bowel function.
结局指标
主要结局
proportion of patients achieving textbook outcome
时间窗: within 90 days after randomization.
textbook outcome is defined as patients either correctly operated (ischemia confirmed at operation ± resection) or correctly managed conservatively (no need for unplanned surgery) with no major postoperative complications (Clavien-Dindo≥3) and a medical length of stay\<5 days (defined as the time at which the patient is medically eligible for discharge), with no postoperative consultation, rehospitalisation and reoperation within 90 days after randomization.
次要结局
- CCI score(postoperative month 1)
- Cumulative length of stay(postoperative month 12)
- QSH45 (questionnaire for satisfaction of hospitalized patients) score evaluating patient satisfaction at postoperative month 1(postoperative month 1)
- 1-, 3-, 6-, 9-, 12-month recurrence rates(within 12 postoperative months)
- Hospital length of stay(postoperative month 12)
- Clavien score postoperative month 1(postoperative month 1)