A Procalcitonin-based Algorithm in Adhesion-related Small Bowel Obstruction

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire, Amiens

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • algorithm

    Diagnostic test

    clinical examination and procalcitonin assessment

Treatment groups

488 Participants
are divided into 2 treatment groups
Group A: algorithm armExperimental treatment 1 intervention
Group B: no algorithm armNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
within 90 days after randomization.

Secondary outcomes

1

1-, 3-, 6-, 9-, 12-month recurrence rates

a new episode of adhesion-related small bowel obstruction.

Time frame
within 12 postoperative months
2

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.

Time frame
postoperative month 1
3

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.

Time frame
postoperative month 1
4

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).

Time frame
postoperative month 1

Other outcomes

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