A Procalcitonin-based Algorithm in Adhesion-related Small Bowel Obstruction

  • STATUS
    Recruiting
  • days left to enroll
    65
  • participants needed
    414
  • sponsor
    Centre Hospitalier Universitaire, Amiens
Updated on 29 July 2021

Summary

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.

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 g/L (for failure of conservative management ) and 0.6 g/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.

Details
Condition Small Bowel Obstruction
Treatment Algorithm
Clinical Study IdentifierNCT03905239
SponsorCentre Hospitalier Universitaire, Amiens
Last Modified on29 July 2021

Eligibility

Yes No Not Sure

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
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