Clinical trial NCT03905239: A Procalcitonin-based Algorithm in Adhesion-related Small Bowel Obstruction
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Small Bowel Obstruction
Keywords: algorithm
procalcitonin
small bowel obstruction
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier de Beauvais
name: University Hospital, Rouen
name: University Hospital, Caen
name: University Hospital, Lille
name: Groupe Hospitalier Pitie-Salpetriere
name: Centre Hospitalier Universitaire Dijon
name: University Hospital, Limoges
name: Saint Antoine University Hospital
name: University Hospital, Clermont-Ferrand
name: Hôpital Cochin
name: University Hospital, Toulouse
name: Centre Hospitalier de PAU
name: Hopital Lariboisière
name: Tourcoing Hospital
name: Central Hospital Saint Quentin
First posted: 2019-04-05
Enrollment: 488
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief 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.

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.

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

Primary outcomes:
measure: proportion of patients achieving textbook outcome
timeFrame: within 90 days after randomization.
Secondary outcomes:
measure: 1-, 3-, 6-, 9-, 12-month recurrence rates
timeFrame: within 12 postoperative months
measure: QSH45 (questionnaire for satisfaction of hospitalized patients) score evaluating patient satisfaction at postoperative month 1
timeFrame: postoperative month 1
measure: Clavien score postoperative month 1
timeFrame: postoperative month 1
measure: CCI score
timeFrame: postoperative month 1
measure: Hospital length of stay
timeFrame: postoperative month 12
measure: Cumulative length of stay
timeFrame: postoperative month 12
Other outcomes:
Locations:
city: Amiens
country: France
facility: Amiens Universitary Hospital
Study officials:
affiliation: CHU Amiens
name: Jean-Marc Regimbeau, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Gastroenterol. 2022 Mar 2;22(1):90. doi: 10.1186/s12876-022-02144-w.