Service de chirurgie digestive, CHU Amiens-Picardie, 1 rond point du Pr Cabrol, 80054, Amiens Cedex 01, France.
UR7518 SSPC, universite de Picardie Jules Verne, 80000, Amiens, France.
BMC Gastroenterol. 2022 Mar 2;22(1):90. doi: 10.1186/s12876-022-02144-w.
Acute adhesion-related small bowel obstruction (ASBO) is a common digestive emergency, accounting for 1 to 3% of all digestive emergencies. The efficacy of conservative management in this setting is a subject of debate, as it may 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. Thus, the decision to perform surgery is difficult. We propose that the introduction of the procalcitonin (PCT)-based algorithm improves the quality of the management of patients with ASBO by aiding the decision of whether or not to perform surgery.
This is a 1:1 cluster-randomized clinical trial (use of algorithm: no algorithm) using an independent computer to ensure that investigators cannot interfere with the randomization. Each cluster will correspond to one investigating center. All patients in a center will be managed in the same way. Before randomization, each principal investigator will provide a commitment to participate in the study to avoid the risk of "empty clusters". The patients included will constitute two parallel arms (use of algorithm versus no algorithm), with no expected crossover between arms. The inclusion criteria are being an adult with uncomplicated acute ASBO (i.e., absence of fever, abdominal pain and distension, nausea and/or vomiting, and the absence of gas and/or stool, in conjunction with a contrast-enhanced CT scan, for patients with previous abdominal surgery) who is able to express consent with a signed written informed consent form. Patients with complicated acute ASBO (strangulation or peritonitis) will be excluded.
There is an ongoing debate on the management of uncomplicated ASBO. The main points are to avoid a surgery if it is unnecessary and to avoid delayed surgery if it is necessary. Currently, there are no robust criteria to objectively determine the failure of non-surgical treatment or to establish the indications for surgery in acute ASBO. Our team proposes the use of procalcitonin (PCT) to help distinguish patients for whom conservative management is likely to be successful from those for whom surgical management is required. The results from a randomized control trial could help in the selection of patients through clear inclusion and exclusion criteria and simplify or clarify the management algorithm. In conclusion, PCT may be useful in evaluating the proper strategy for ASBO. Trial registration The trial is registered at clinical trials under the reference: NCT03905239.
急性粘连性小肠梗阻（ASBO）是一种常见的消化系统急症，占所有消化系统急症的 1%至 3%。在这种情况下，保守治疗的疗效存在争议，因为它可能会延迟手术决策，并增加肠切除的频率（例如，在存在肠坏死的情况下），或者相反，促使进行过多不必要的剖腹手术。因此，手术决策很困难。我们提出，降钙素原（PCT）算法的引入通过辅助决定是否进行手术，可提高 ASBO 患者管理的质量。
这是一项 1:1 集群随机临床试验（使用算法：无算法），使用独立的计算机以确保调查人员无法干预随机化。每个集群将对应一个调查中心。一个中心的所有患者都将以相同的方式进行管理。在随机分组之前，每个主要研究者将提供参与研究的承诺，以避免“空集群”的风险。纳入的患者将构成两个平行的手臂（使用算法与不使用算法），两个手臂之间预计不会交叉。纳入标准为：成人患有单纯性急性 ASBO（即无发热、腹痛和腹胀、恶心和/或呕吐，以及结合先前腹部手术患者的增强 CT 扫描无气体和/或粪便），能够以书面知情同意书的形式表达同意。伴有复杂性急性 ASBO（绞窄或腹膜炎）的患者将被排除。
单纯性 ASBO 的管理存在争议。主要观点是避免不必要的手术，如果有必要则避免延迟手术。目前，没有可靠的标准来客观确定非手术治疗的失败或确定急性 ASBO 手术的指征。我们的团队提出使用降钙素原（PCT）来帮助区分保守治疗可能成功的患者和需要手术治疗的患者。随机对照试验的结果可以通过明确的纳入和排除标准帮助选择患者，并简化或澄清管理算法。总之，PCT 可能有助于评估 ASBO 的适当策略。
该试验在临床试验中注册，参考号：NCT03905239。
