About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Uncomplicated acute adhesion-related small bowel obstruction (ASBO)
Adults
Patients able to express consent
Signed written informed consent form
Disqualifiers
Large bowel obstruction
No previous abdominal surgery
Signs of peritonitis or strangulation requiring emergency surgery)
Obstruction within 4 weeks following previous surgery
Trial design
Parallel
Treatments tested in this trial
algorithm
Diagnostic testclinical examination and procalcitonin assessment
Treatment groups
Trial outcomes
Primary outcomes
proportion of patients achieving textbook outcome
textbook outcome is defined as patients either correctly operated (ischemia confirmed at operation ± resection) or correctly managed conservatively (no need for unplanned surgery) with no major postoperative complications (Clavien-Dindo≥3) and a medical length of stay\<5 days (defined as the time at which the patient is medically eligible for discharge), with no postoperative consultation, rehospitalisation and reoperation within 90 days after randomization.
Secondary outcomes
1-, 3-, 6-, 9-, 12-month recurrence rates
a new episode of adhesion-related small bowel obstruction.
QSH45 (questionnaire for satisfaction of hospitalized patients) score evaluating patient satisfaction at postoperative month 1
Evaluation of patient satisfaction at postoperative month 1. Values of scores are between 0 and 100. 0 is the minimum score. 100 is the maximum score. In QSH45 : 45 questions are asked to the patient. Each question has a score from 1 (worst) to 5 (best score). The QSH45 score is divided in 8 subscales. The 45 questions are placed equally in the 8 subscales. the total score (QSH45) is the average of the score of the 8 subscales.
Clavien score postoperative month 1
The therapy used to correct a specific complication in the basis of this classification on order to rank a complication in an objective and reproducible manner. It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V). Grade I is the minimum value of the score. Grade V is the maximum value of the score corresponding to the death of a patient.
CCI score
The CCI calculator is an online tool to support the assessment of patients' overall morbidity. The comprehensive complication index (CCI) is based on the complication grading by Clavien-Dindo Classification and implements every occured complication after an intervention. The overall morbidity is reflected on a scale from 0 (no complication) to 100 (death).
Sponsors and contacts
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Centre Hospitalier Universitaire, Amiens
Lead sponsor
Centre Hospitalier de Beauvais
Collaborator
University Hospital, Rouen
Collaborator
University Hospital, Caen
Collaborator
University Hospital, Lille
Collaborator
Groupe Hospitalier Pitie-Salpetriere
Collaborator
Centre Hospitalier Universitaire Dijon
Collaborator
University Hospital, Limoges
Collaborator
Saint Antoine University Hospital
Collaborator
University Hospital, Clermont-Ferrand
Collaborator
Hôpital Cochin
Collaborator
University Hospital, Toulouse
Collaborator
Centre Hospitalier de PAU
Collaborator
Hopital Lariboisière
Collaborator
Tourcoing Hospital
Collaborator
Central Hospital Saint Quentin
Collaborator