A Procalcitonin-based Algorithm in Adhesion-related Small Bowel Obstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: algorithm.
- Who it may be relevant to
- Registry conditions: Small Bowel Obstruction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
Overview
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.
Detailed description
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.
Interventions
- Diagnostic test algorithm
clinical examination and procalcitonin assessment
Primary outcome measures
- proportion of patients achieving textbook outcome [Time frame: within 90 days after randomization.]
Secondary outcome measures (6)
- 1-, 3-, 6-, 9-, 12-month recurrence rates [Time frame: within 12 postoperative months]
- QSH45 (questionnaire for satisfaction of hospitalized patients) score evaluating patient satisfaction at postoperative month 1 [Time frame: postoperative month 1]
- Clavien score postoperative month 1 [Time frame: postoperative month 1]
- CCI score [Time frame: postoperative month 1]
- Hospital length of stay [Time frame: postoperative month 12]
- Cumulative length of stay [Time frame: postoperative month 12]
Eligibility criteria
Inclusion criteria
- Uncomplicated acute adhesion-related small bowel obstruction (ASBO)
- Adults
- Patients able to express consent
- Signed written informed consent form
- Covered by national health insurance
Exclusion criteria
- 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
- Minors
- Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision)
- Pregnancy or breastfeeding
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Amiens Universitary Hospital — Amiens
Publications
- Sabbagh C, Mauvais F, Tuech JJ, Tresallet C, Ortega-Debalon P, Mathonnet M, Lefevre JH, Lakkis Z, Fuks D, Muscari F, Dron B, Couderc P, Alves A, Regimbeau JM. 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. BMC PMID 35236281
Identifiers
NCT: NCT03905239 · PI2018_843_0029