Impact of a procalcitonin-based algorithm on the quality of management of patients with uncomplicated adhesion-related small bowel obstruction assessed by a textbook outcome: a multicenter cluster-randomized open-label controlled trial.
Background: 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 fre...
| Published in: | BMC Gastroenterology Vol. 22; no. 1; pp. 1 - 8 |
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| Main Authors: | , , , , , , , , , , , , , |
| Format: | research tables/charts randomized controlled trial Journal Article |
| Published: |
BioMed Central
3/2/2022
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| Online Access: | View this record in EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=155548687&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 155548687 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 1471230X 1CHO jtl: BMC Gastroenterology issn: 1471230X maglogo: N pubinfo: dt: 3/2/2022 vid: 22 iid: 1 pid: 24147 pub: BioMed Central artinfo: ui: 155548687 155548687 NLM35236281 155548687 10.1186/s12876-022-02144-w NLM35236281 155548687 ppf: 1 ppct: 7 formats: tig: atl: Impact of a procalcitonin-based algorithm on the quality of management of patients with uncomplicated adhesion-related small bowel obstruction assessed by a textbook outcome: a multicenter cluster-randomized open-label controlled trial. aug: au: Sabbagh, Charles Mauvais, Francois Tuech, Jean-Jacques Tresallet, Christophe Ortega-Debalon, Pablo Mathonnet, Muriel Lefevre, Jeremie H. Lakkis, Zaher Fuks, David Muscari, Fabrice Dron, Bernard Couderc, Philippe Alves, Arnaud Regimbeau, Jean-Marc affil: Service de chirurgie digestive, CHU Amiens-Picardie, 1 rond point du Pr Cabrol, 80054, Amiens Cedex 01, France sug: subj: Intestinal Obstruction Etiology Intestinal Obstruction Surgery Adhesions Surgery Adhesions Complications Adult Laparotomy Algorithms Treatment Outcomes Human Comparative Studies Multicenter Studies Randomized Controlled Trials Evaluation Research Validation Studies Impact of Events Scale Ferrans and Powers Quality of Life Index Adult: 19-44 years ab: Background: 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.Methods: 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.Discussion: 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. pubtype: Academic Journal doctype: research tables/charts randomized controlled trial Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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