Actively Recruiting
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-06-08
488
Participants Needed
1
Research Sites
43 weeks
Total Duration
C
Centre Hospitalier Universitaire, Amiens
Lead Sponsor
C
Centre Hospitalier de Beauvais
Collaborating Sponsor
Adhesion-related small bowel obstruction (ASBO) is a common digestive emergency that can be treated either conservatively or with surgery. This condition carries a risk of death, especially if surgery is delayed. Researchers are evaluating a procalcitonin-based algorithm to improve decision-making between these treatment options, aiming to enhance patient management and outcomes. The study compares two approaches: one uses clinical examination combined with procalcitonin blood tests to guide treatment decisions, while the other relies on clinical examination alone without procalcitonin testing. Patients in both groups initially receive conservative care including nasogastric tubes and intravenous fluids, with surgery considered after 48 hours if bowel function does not return. The algorithm arm uses specific procalcitonin thresholds to identify patients needing surgery sooner. Participants will be monitored for up to 90 days to see how many achieve a textbook outcome, which reflects quality care. Additional assessments include patient satisfaction questionnaires, complication scores, and length of hospital stay up to 12 months after surgery. The study involves clinical exams, blood tests, and follow-ups to evaluate the impact of the algorithm on treatment timing and patient recovery.
CONDITIONS
A Procalcitonin-based Algorithm in Adhesion-related Small Bowel Obstruction
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 hours from initiation of conservative management
Participants undergo clinical examination and procalcitonin assessment to guide management decisions.
1 to 2 visits depending on clinical assessment and procalcitonin testing
Duration - Up to 48 hours or until surgical decision is made
Participants receive conservative management including nasogastric tube, intravenous fluids, and monitoring; surgery is performed if indicated by clinical or procalcitonin findings.
1 to 2 visits during conservative management and possible surgery
Duration - Up to 12 months post-treatment
Participants are monitored after surgery or completion of conservative management for recovery and assessment of outcomes.
Follow-up visits at 1, 3, 6, 9, and 12 months postoperatively
Total: 1 location
1
Amiens Universitary Hospital
Amiens, France
Actively Recruiting
J
Jean-Marc Regimbeau, Pr
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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Charles Sabbagh, Francois Mauvais, Jean-Jacques Tuech...
https://pubmed.ncbi.nlm.nih.gov/35236281