Small Bowel ObstructionALPROCNCT03905239
A Procalcitonin-based Algorithm in Adhesion-related Small Bowel Obstruction
A study testing algorithm in people with Small Bowel Obstruction, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Bowel Obstruction
- What is being tested?
- algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 488 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2019to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Uncomplicated acute adhesion-related small bowel obstruction (ASBO)
- Adults
- Patients able to express consent
- Signed written informed consent form
- Covered by national health insurance
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Amiens Universitary Hospital
Amiens
jean marc Regimbeau, MD, PhD, +33 3 22 08 89 05, regimbeau.jean-marc@chu-amiens.fr
About this study
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)
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.
Read the 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.
- Conditions
- Small Bowel Obstruction
- Being tested
- algorithm
- Keywords
- algorithm, procalcitonin, small bowel obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
algorithmDiagnostic test
clinical examination and procalcitonin assessment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 90 days after randomization.
Secondary outcomes (6)
1-, 3-, 6-, 9-, 12-month recurrence rates
a new episode of adhesion-related small bowel obstruction.
Measured: within 12 postoperative months
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.
Measured: postoperative month 1
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.
Measured: postoperative month 1
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).
Measured: postoperative month 1
Hospital length of stay
the interval between admission to the emergency department and discharge from the ward.
Measured: postoperative month 12
Cumulative length of stay
total number of days of hospitalization related to ASBO
Measured: postoperative month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start1 Apr 2019
- Primary completionOct 2025 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Small Bowel ObstructionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 488 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier de Beauvais, University Hospital, Rouen, University Hospital, Caen, University Hospital, Lille, Groupe Hospitalier Pitie-Salpetriere, Centre Hospitalier Universitaire Dijon, University Hospital, Limoges, Saint Antoine University Hospital, University Hospital, Clermont-Ferrand, Hôpital Cochin, University Hospital, Toulouse, Centre Hospitalier de PAU, Hopital Lariboisière, Tourcoing Hospital, Central Hospital Saint Quentin
- Responsible party
- Sponsor
- Investigators
- Jean-Marc Regimbeau, Pr, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905239
- Sponsor's protocol ID
- PI2018_843_0029
- Acronym
- ALPROC
- Status last verified
- Jun 2025
- First submitted
- 21 Feb 2019
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35236281
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03905239
- Acronym / sponsor ID
- ALPROC / PI2018_843_0029
- Conditions
- Small Bowel Obstruction
- Keywords
- algorithm, procalcitonin, small bowel obstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 488 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Collaborators
- Centre Hospitalier de Beauvais, University Hospital, Rouen, University Hospital, Caen, University Hospital, Lille, Groupe Hospitalier Pitie-Salpetriere, Centre Hospitalier Universitaire Dijon, University Hospital, Limoges, Saint Antoine University Hospital, University Hospital, Clermont-Ferrand, Hôpital Cochin, University Hospital, Toulouse, Centre Hospitalier de PAU, Hopital Lariboisière, Tourcoing Hospital, Central Hospital Saint Quentin
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| algorithm arm | Experimental | Diagnostic Test: algorithmPatient 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Uncomplicated acute adhesion-related small bowel obstruction (ASBO)
- Adults
- Patients able to express consent
- Signed written informed consent form
- Covered by national health insurance
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| algorithmclinical examination and procalcitonin assessment | Diagnostic test | algorithm arm |
Primary outcome
proportion of patients achieving textbook outcome
Time frame: within 90 days after randomization.
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.
6 secondary outcomes
1-, 3-, 6-, 9-, 12-month recurrence rates
Time frame: within 12 postoperative months
QSH45 (questionnaire for satisfaction of hospitalized patients) score evaluating patient satisfaction at postoperative month 1
Time frame: postoperative month 1
Clavien score postoperative month 1
Time frame: postoperative month 1
CCI score
Time frame: postoperative month 1
Hospital length of stay
Time frame: postoperative month 12
Cumulative length of stay
Time frame: postoperative month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Derived from this study: PubMed 35236281Sabbagh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean-Marc Regimbeau, Pr principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing algorithm in people with Small Bowel Obstruction, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Marc Regimbeau, Pr ((33) 322 088 897, regimbeau.jean-marc@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients achieving textbook outcome (time frame: within 90 days after randomization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03905239, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.