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

NCT03905239 | Recruiting DMC

• 1 other identifier: PI2018_843_0029
• Study Type: interventional
• Target: 488
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Bowel Obstruction

Keywords

algorithm; procalcitonin; small bowel obstruction

Outcome Measures

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.

  within 90 days after randomization.

Secondary Outcomes (6)

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

  within 12 postoperative months

• QSH45 (questionnaire for satisfaction of hospitalized patients) score evaluating patient satisfaction at postoperative month 1

  postoperative month 1

• Clavien score postoperative month 1

  postoperative month 1

• CCI score

  postoperative month 1

• Hospital length of stay

  postoperative month 12

Study Arms (2)

algorithm arm

EXPERIMENTAL

Patient management is based on clinical examination and procalcitonin assessment. From 48 hours after initiation of conservative management in the case of absence of bowel function, operative management (adhesiolysis or bowel resection) will be performed. In the event of discordance between procalcitonin values and clinical examination, management will always be based on clinical examination.

Diagnostic Test: algorithm

no algorithm arm

NO INTERVENTION

Patient management is based on clinical examination. Conservative management will be continued for 48 hours in the absence of signs of bowel ischemia (clinical and laboratory assessment other than procalcitonin, as procalcitonin will not be assayed in this arm). Gastrografin will not be used in this arm. Operative management (adhesiolysis or bowel resection) will be performed 48 hours after initiation of conservative management or in the case of absence of bowel function.

Interventions

algorithm DIAGNOSTIC_TEST

clinical examination and procalcitonin assessment

algorithm arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Uncomplicated acute adhesion-related small bowel obstruction (ASBO)
• Adults
• Patients able to express consent
• Signed written informed consent form
• Covered by national health insurance

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead
• 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

Study Sites (1)

Amiens Universitary Hospital

Amiens, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 35236281 DERIVED

MeSH Terms

Interventions

Algorithms

Intervention Hierarchy (Ancestors)

Mathematical Concepts

Study Officials

• Jean-Marc Regimbeau, Pr

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Marc Regimbeau, Pr

CONTACT

(33) 322 088 897; regimbeau.jean-marc@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: April 5, 2019
• Study Start: April 1, 2019
• Primary Completion: October 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: June 8, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)