Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT03905239 En recrutement

Titre

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) (ALPROC)

Type

Interventional

Pathologie

Occlusion intestinale

Phase

N/A

Promoteur

Centre Hospitalier Universitaire, Amiens (Voir sur ClinicalTrials)

Date de début

avril 2019

Date de fin

août 2024

Dernière mise à jour

29 juin 2024

Résumé

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.

Détail

Voir le détail 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. Fermer le détail

Etablissements

Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Amiens Universitary Hospital - Amiens - France	jean marc Regimbeau, MD, PhD	En recrutement		Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

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

Critère de non inclusion

- 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

NCT03905239 - 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) (ALPROC)

Informations générales
Etablissements
Critères
Accès à la fiche NCT

Retour en haut