SBO - Small Bowel ObstructionSBO- CHOICENCT07860177
Management of Non Emergency Adhesive Small Bowel Obstruction:
An observational study of SBO - Small Bowel Obstruction, run by Azienda Sanitaria di Firenze at 1 site in Italy.
Trial summary
SBO-CHOICE is a prospective, multicenter observational study investigating the management of adhesive small bowel obstruction (ASBO), a condition in which scar tissue (adhesions), usually resulting from previous abdominal surgery, causes a blockage of the small intestine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SBO - Small Bowel Obstruction
- What is being tested?
- Surgical group
- Type of treatment
- Surgery or procedure
- How many people
- 690 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2026to 1 Nov 2031
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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
Study population: The study population includes all consecutive adult patients (≥18 years of age) presenting acutely ( unplanned) and non-elective presentation to hospital for urgent or emergency reasons) at the participating centers with a clinical and radiological diagnosis of Adhesive small bowel obstruction. All enrolled patients will be managed according to routine clinical practice.
Who may be able to join
- Age ≥ 18 years
- Admission for suspected small bowel obstruction
- Diagnosis of adhesive small bowel obstruction supported by:
- Clinical criteria, including at least two of the following:Objectively abdominal pain consistent with bowel obstruction, persistent vomiting or nasogastric aspirate, Abdominal distension, failure to pass flatus or stool.
- CT findings consistent with small bowel obstruction, including: Dilated small bowel loops with air-fluid levels,Identification of one or more transition points, Absence of alternative causes of obstruction.
- CT features compatible with adhesions, such as: Abrupt transition without mass lesion, Beak sign or angulation of bowel loops, Adhesive bands or clustering of loop
Who cannot join
- Clinical or radiological signs of bowel ischemia or strangulation, including:
- Peritonitis
- Pneumatosis intestinalis
- Portal venous gas
- Free intraperitoneal air
- Reduced or absent bowel wall enhancement on CT
Show all 14Show fewer
- Closed-loop obstruction
- Hemodynamic instability or acute abdomen with systemic compromise
- Obstruction due to causes other than adhesions
- Recurrent adhesive small bowel obstruction (defined as any previous episode of clinically suspected or radiologically confirmed adhesive small bowel obstruction occurring before the index admission, regardless of whether the episode required hospital admission or was managed in an outpatient setting). During enrollment,
- investigators will record the number and approximate timing of previous obstructive episodes, including those not requiring hospital admission.
- Immediate need for emergency surgery
- Inability to provide informed consent
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Pragmatic Investigation of Surgical Versus Medical Management in Non-emergent Adhesive Small Bowel Obstruction: a Prospective Multicenter Observational Cohort Study (SBO- CHOICE).
SBO-CHOICE is a prospective, multicenter observational study investigating the management of adhesive small bowel obstruction (ASBO), a condition in which scar tissue (adhesions), usually resulting from previous abdominal surgery, causes a blockage of the small intestine.
Adhesive small bowel obstruction is a common reason for emergency hospital admission. In patients who do not have signs of bowel ischemia, strangulation, peritonitis, or other conditions requiring immediate surgery, treatment may initially be non-operative. This can include intravenous fluids, temporary fasting, placement of a nasogastric tube when needed, and the use of water-soluble contrast agents. Many patients recover without an operation. However, some patients eventually require surgery, and bowel obstruction may recur after discharge.At present, it remains uncertain which treatment strategy provides the best long-term outcomes for patients in whom surgery is considered a reasonable option but is not immediately necessary.
- What is the purpose of the study? The main purpose of SBO-CHOICE is to compare the outcomes of adult patients admitted with adhesive small bowel obstruction who are treated: with surgery during their initial hospital admission, or with non-operative (medical) management and discharged without surgery. The primary outcome is whether patients are readmitted to hospital because of another episode of adhesive small bowel obstruction within 12 months. The study will also examine other important outcomes, including the need for emergency surgery during follow-up, complications, mortality, length of hospital stay, further adhesion-related procedures, and patients' quality of life.
- Does participation determine which treatment a patient receives? SBO-CHOICE is an observational study and does not assign patients to a particular treatment.All diagnostic and treatment decisions are made by the treating surgical team according to the patient's clinical condition and normal clinical practice. Participation in the study does not require doctors to change their usual treatment or follow a study-specific treatment algorithm. The researchers will observe and compare what happens to patients who receive the different treatment strategies in real-world clinical practice.
- Who can participate? The study includes adults aged 18 years or older who are admitted urgently to participating hospitals with a clinical and CT-confirmed diagnosis of adhesive small bowel obstruction.Patients who require immediate emergency surgery, including those with signs of bowel ischemia, strangulation, peritonitis, hemodynamic instability, or other serious complications, are not included in the study. Other exclusion criteria are specified in the study protocol.
- What happens after enrollment? Clinical information regarding the initial hospital admission and the treatment received will be collected. After discharge, patients will be followed by telephone at approximately 30 days, 90 days, 6 months, and annually thereafter for up to 5 years. During follow-up, researchers will collect information about complications, further hospital admissions, recurrent bowel obstruction, additional procedures or operations, and other relevant clinical outcomes. Quality of life will also be assessed using validated questionnaires.
- Are there additional risks from participating? Because SBO-CHOICE is observational, participation does not introduce an experimental treatment or alter routine clinical management. Treatment-related risks are therefore those associated with the medical or surgical care that the patient would receive independently of participation in the study. Patients will receive detailed information about the study before enrollment and will be asked to provide written informed consent. Participation is voluntary, and patients may withdraw their consent at any time without affecting the quality of their medical care.
- How will personal information be protected? Clinical and study data will be collected in a secure electronic database. Patient-identifying information such as names, addresses, telephone numbers, or dates of birth will not be entered into the study database. Study data will be pseudonymized using an alphanumeric code and managed according to appropriate confidentiality and data-protection procedures. Results may be presented at scientific meetings or published in scientific journals, but only in aggregated or anonymous form so that individual participants cannot be identified.
- Why is this study important? Although non-operative treatment is successful in many patients with adhesive small bowel obstruction, recurrence remains an important clinical problem. Surgery may reduce the risk of future obstruction in selected patients, but it also carries operative risks and may itself lead to the formation of new adhesions.The study want to provide better evidence about the short- and long-term outcomes of these patients.
- Conditions
- SBO - Small Bowel Obstruction
- Being tested
- Surgical group
- Keywords
- Small bowel obstruction, Non operative management, Surgery, Recurrence
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical groupProcedure or surgery
Patients who undergo operative management for ASBO during the index hospitalization.
| Study group | Role | What they receive |
|---|---|---|
| Non Surgical group | Patients who are discharged without surgery, having achieved resolution of obstruction through medical management alone. Receives: Procedure: Surgical group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission within 12 months
Hospital readmission for adhesive small bowel obstruction within 12 months after the index admission, defined using the same clinical and CT criteria applied for study inclusion.
Measured: 12 months
Secondary outcomes (6)
Emergency surgical intervention incidence
Emergency surgical intervention incidence during follow-up due to the development of absolute surgical indications including bowel ischemia, strangulation, peritonitis, or hemodynamic instability
Measured: 5 years
Mortality
Measured: 5 years
Length of hospital stay
Measured: 12 months
Post-discharge complications
Post-discharge complications, specifically including:
Recurrent adhesive small bowel obstruction requiring hospital readmission; Adhesion-related reoperation (elective or emergency); Obstruction-related complications requiring invasive procedures (e.g., nasogastric decompression requiring hospital admission, percutaneous decompression, or prolonged parenteral nutritional support).
Measured: 5 years
Quality of life
SF-36 (general health-related quality of life)
Unit of Measure: Units on a scale Min 0, Max 100
Measured: 5 years
Quality of life
GIQLI (Gastrointestinal Quality of Life Index) for bowel-related function.
Unit of Measure: Units on a scale Min 0, Max 144
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SBO - 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 690 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria di Firenze
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessio Giordano, Azienda Sanitaria di Firenze
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860177
- Sponsor's protocol ID
- ASFirenze27
- Acronym
- SBO- CHOICE
- Status last verified
- Sep 2026
- First submitted
- 24 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abera SA, Adem AA, Endawkie A, Ahmed AN, Mohammed S. Success rate and associated factors of conservative management of adhesive small bowel obstruction at Dessie comprehensive specialized hospital, Northeast Ethiopia. Sci Rep. 2025 Oct 21;15(1):36570. doi: 10.1038/s41598-025-20288-z.
PubMed 41120454Di Saverio S, Coccolini F, Galati M, Smerieri N, Biffl WL, Ansaloni L, Tugnoli G, Velmahos GC, Sartelli M, Bendinelli C, Fraga GP, Kelly MD, Moore FA, Mandala V, Mandala S, Masetti M, Jovine E, Pinna AD, Peitzman AB, Leppaniemi A, Sugarbaker PH, Goor HV, Moore EE, Jeekel J, Catena F. Bologna guidelines for diagnosis and management of adhesive small bowel obstruction (ASBO): 2013 update of the evidence-based guidelines from the world society of emergency surgery ASBO working group. World J Emerg Surg. 2013 Oct 10;8(1):42. doi: 10.1186/1749-7922-8-42.
PubMed 24112637
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Investigation of Surgical Versus Medical Management in Non-emergent Adhesive Small Bowel Obstruction: a Prospective Multicenter Observational Cohort Study (SBO- CHOICE).
- ClinicalTrials.gov ID
- NCT07860177
- Acronym / sponsor ID
- SBO- CHOICE / ASFirenze27
- Conditions
- SBO - Small Bowel Obstruction
- Keywords
- Small bowel obstruction, Non operative management, Surgery, Recurrence
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 690 participants (estimated)
- Lead sponsor
- Azienda Sanitaria di FirenzeUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2031 (estimated)
- First posted
- 6 Oct 2026 (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.
SBO-CHOICE is a prospective, multicenter observational study investigating the management of adhesive small bowel obstruction (ASBO), a condition in which scar tissue (adhesions), usually resulting from previous abdominal surgery, causes a blockage of the small intestine.
Adhesive small bowel obstruction is a common reason for emergency hospital admission. In patients who do not have signs of bowel ischemia, strangulation, peritonitis, or other conditions requiring immediate surgery, treatment may initially be non-operative. This can include intravenous fluids, temporary fasting, placement of a nasogastric tube when needed, and the use of water-soluble contrast agents. Many patients recover without an operation. However, some patients eventually require surgery, and bowel obstruction may recur after discharge.At present, it remains uncertain which treatment strategy provides the best long-term outcomes for patients in whom surgery is considered a reasonable option but is not immediately necessary.
- What is the purpose of the study? The main purpose of SBO-CHOICE is to compare the outcomes of adult patients admitted with adhesive small bowel obstruction who are treated: with surgery during their initial hospital admission, or with non-operative (medical) management and discharged without surgery. The primary outcome is whether patients are readmitted to hospital because of another episode of adhesive small bowel obstruction within 12 months. The study will also examine other important outcomes, including the need for emergency surgery during follow-up, complications, mortality, length of hospital stay, further adhesion-related procedures, and patients' quality of life.
- Does participation determine which treatment a patient receives? SBO-CHOICE is an observational study and does not assign patients to a particular treatment.All diagnostic and treatment decisions are made by the treating surgical team according to the patient's clinical condition and normal clinical practice. Participation in the study does not require doctors to change their usual treatment or follow a study-specific treatment algorithm. The researchers will observe and compare what happens to patients who receive the different treatment strategies in real-world clinical practice.
- Who can participate? The study includes adults aged 18 years or older who are admitted urgently to participating hospitals with a clinical and CT-confirmed diagnosis of adhesive small bowel obstruction.Patients who require immediate emergency surgery, including those with signs of bowel ischemia, strangulation, peritonitis, hemodynamic instability, or other serious complications, are not included in the study. Other exclusion criteria are specified in the study protocol.
- What happens after enrollment? Clinical information regarding the initial hospital admission and the treatment received will be collected. After discharge, patients will be followed by telephone at approximately 30 days, 90 days, 6 months, and annually thereafter for up to 5 years. During follow-up, researchers will collect information about complications, further hospital admissions, recurrent bowel obstruction, additional procedures or operations, and other relevant clinical outcomes. Quality of life will also be assessed using validated questionnaires.
- Are there additional risks from participating? Because SBO-CHOICE is observational, participation does not introduce an experimental treatment or alter routine clinical management. Treatment-related risks are therefore those associated with the medical or surgical care that the patient would receive independently of participation in the study. Patients will receive detailed information about the study before enrollment and will be asked to provide written informed consent. Participation is voluntary, and patients may withdraw their consent at any time without affecting the quality of their medical care.
- How will personal information be protected? Clinical and study data will be collected in a secure electronic database. Patient-identifying information such as names, addresses, telephone numbers, or dates of birth will not be entered into the study database. Study data will be pseudonymized using an alphanumeric code and managed according to appropriate confidentiality and data-protection procedures. Results may be presented at scientific meetings or published in scientific journals, but only in aggregated or anonymous form so that individual participants cannot be identified.
- Why is this study important? Although non-operative treatment is successful in many patients with adhesive small bowel obstruction, recurrence remains an important clinical problem. Surgery may reduce the risk of future obstruction in selected patients, but it also carries operative risks and may itself lead to the formation of new adhesions.The study want to provide better evidence about the short- and long-term outcomes of these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non Surgical group | – | Procedure: Surgical groupPatients who are discharged without surgery, having achieved resolution of obstruction through medical management alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes all consecutive adult patients (≥18 years of age) presenting acutely ( unplanned) and non-elective presentation to hospital for urgent or emergency reasons) at the participating centers with a clinical and radiological diagnosis of Adhesive small bowel obstruction. All enrolled patients will be managed according to routine clinical practice.
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Admission for suspected small bowel obstruction
- Diagnosis of adhesive small bowel obstruction supported by:
- Clinical criteria, including at least two of the following:Objectively abdominal pain consistent with bowel obstruction, persistent vomiting or nasogastric aspirate, Abdominal distension, failure to pass flatus or stool.
- CT findings consistent with small bowel obstruction, including: Dilated small bowel loops with air-fluid levels,Identification of one or more transition points, Absence of alternative causes of obstruction.
Key exclusion criteria (14 listed)
- Clinical or radiological signs of bowel ischemia or strangulation, including:
- Peritonitis
- Pneumatosis intestinalis
- Portal venous gas
- Free intraperitoneal air
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 |
|---|---|---|
| Surgical groupPatients who undergo operative management for ASBO during the index hospitalization. | Procedure or surgery | Non Surgical group |
Primary outcome
Readmission within 12 months
Time frame: 12 months
Hospital readmission for adhesive small bowel obstruction within 12 months after the index admission, defined using the same clinical and CT criteria applied for study inclusion.
6 secondary outcomes
Emergency surgical intervention incidence
Time frame: 5 years
Mortality
Time frame: 5 years
Length of hospital stay
Time frame: 12 months
Post-discharge complications
Time frame: 5 years
Quality of life
Time frame: 5 years
Quality of life
Time frame: 5 years
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 6 Oct 2026.
- Background: PubMed 41120454Abera SA, Adem AA, Endawkie A, Ahmed AN, Mohammed S. Success rate and associated factors of conservative management of adhesive small bowel obstruction at Dessie comprehensive specialized hospital, Northeast Ethiopia. Sci Rep. 2025 Oct 21;15(1):36570. doi: 10.1038/s41598-025-20288-z.
- Results publication: PubMed 24112637Di Saverio S, Coccolini F, Galati M, Smerieri N, Biffl WL, Ansaloni L, Tugnoli G, Velmahos GC, Sartelli M, Bendinelli C, Fraga GP, Kelly MD, Moore FA, Mandala V, Mandala S, Masetti M, Jovine E, Pinna AD, Peitzman AB, Leppaniemi A, Sugarbaker PH, Goor HV, Moore EE, Jeekel J, Catena F. Bologna guidelines for diagnosis and management of adhesive small bowel obstruction (ASBO): 2013 update of the evidence-based guidelines from the world society of emergency surgery ASBO working group. World J Emerg Surg. 2013 Oct 10;8(1):42. doi: 10.1186/1749-7922-8-42.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SBO - Small Bowel Obstruction, run by Azienda Sanitaria di Firenze at 1 site in Italy.
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 6 inclusion and 14 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: enrolling by invitation, as of the sponsor's last update on 6 Oct 2026. 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 Italy. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readmission within 12 months (time frame: 12 months). 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 NCT07860177, which also lists 2 linked publications.
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 6 Oct 2026.