Procalcitonin-guided care for adhesion-related small bowel obstruction
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)
This study tests whether using blood procalcitonin levels to guide the choice between surgery and conservative care helps adults with adhesion-related small bowel obstruction.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 488 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT03905239 on ClinicalTrials.gov |
What this trial studies
Adults with uncomplicated adhesion-related small bowel obstruction will be managed using a predefined algorithm that incorporates blood procalcitonin (PCT) measurements alongside standard clinical and CT assessments. Eligible patients are enrolled at participating French university hospitals and managed according to the algorithm to decide early surgery versus conservative treatment. Key outcomes include rates of surgery, need for bowel resection, length of hospital stay, and in-hospital complications, with follow-up through the immediate hospitalization period. The strategy aims to reduce delayed emergency operations for strangulation and avoid unnecessary laparotomies by using PCT as a potential marker of infection and bowel ischemia.
Who should consider this trial
Good fit: Adults with uncomplicated adhesion-related small bowel obstruction who can give informed consent, are covered by national health insurance, and have no signs requiring immediate surgery are ideal candidates.
Not a fit: Patients with signs of peritonitis or strangulation, recent abdominal surgery (within 4 weeks), large-bowel obstruction, active infection, known bowel cancer or inflammatory bowel disease, pregnancy, minors, or those unable to consent are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the PCT-based algorithm could reduce unnecessary surgeries, lower rates of delayed bowel resection, and shorten hospital stays.
How similar studies have performed: Using procalcitonin to guide decisions in suspected bowel ischemia is relatively novel: small studies suggest it may help identify infection or ischemia, but large randomized evidence is limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amiens
- Amiens Universitary Hospital — Amiens, France (Recruiting)
Study contacts
- Principal investigator: Jean-Marc Regimbeau, Pr — CHU Amiens
- Study coordinator: Jean-Marc Regimbeau, Pr
- Email: regimbeau.jean-marc@chu-amiens.fr
- Phone: (33) 322 088 897
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.