Pragmatic Investigation of Surgical Versus Medical Management in Non-emergent Adhesive Small Bowel Obstruction: a Prospective Multicenter Observational Cohort Study (SBO- CHOICE).
| Registry | NCT07860177, acronym SBO- CHOICE |
|---|---|
| Status | Enrolling by invitation |
| Study type | Observational |
| Enrollment | 690 (Estimated) |
| Sponsor | Azienda Sanitaria di Firenze (Other) |
| Conditions | SBO - Small Bowel Obstruction |
| Interventions | Surgical group (Procedure) |
| Dates | start 2026-11-01 (estimated), primary completion 2027-11-01 (estimated), completion 2031-11-01 (estimated), first posted 2026-10-06, last updated 2026-10-06 |
| Locations | 1 site in Italy |
Related Papers Related Patents Related Grants Related Experts
All trials for SBO - Small Bowel Obstruction All trials of Surgical group
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.
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.
7. 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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Non Surgical group | Procedure: Surgical group | Patients who are discharged without surgery, having achieved resolution of obstruction through medical management alone. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
| Facility | City | Country | Status |
|---|---|---|---|
| AOU Careggi | Florence, FI | Italy |