Intestinal ObstructionNCT01125280
Prospective Multicenter Validation of a Severity Score of Strangulated Small Bowel Occlusion
A study testing Conservative treatment versus surgical treatment in people with Intestinal Obstruction, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
The purpose of this study is to apply and validate a clinicoradiological score for the prediction of severity of strangulated small bowel occlusion (SBO). This score was elaborated by analyzing clinical, biological and radiological parameters of patients admitted in an emergency center for acute strangulated SBO. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Intestinal Obstruction
- What is being tested?
- Conservative treatment versus surgical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2010to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Strangulated small bowel occlusion
- Diagnosis confirmation by CT-scan with iv contrast
- Blood analysis comprising: leucocyte count and repartition, CRP, lactates
Who cannot join
- Large bowel occlusion
- Strangulated hernia
- Tumor occlusion
- Post-Radiotherapy occlusion
- Paralytic ileus (neurological diseases, diabetes, etc)
- Inflammatory bowel diseases
- Any condition able to modify the clinical or biological parameters without any relation with the SBO episode (inflammatory, infectious diseases, etc)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Division of visceral and transplantation surgery, Department of surgery, Geneva University Hospital
Geneva, Canton of Geneva, 1211
Frank P Schwenter, MD, PhD, +41223727703, frank.schwenter@hcuge.ch
Philippe Morel, MD, +41223727702, philippe.morel@hcuge.ch
About this study
Official title: Prospective Multicenter Validation of a Clinicoradiological Score for Predicting the Severity of Strangulated Small Bowel Occlusion
The purpose of this study is to apply and validate a clinicoradiological score for the prediction of severity of strangulated small bowel occlusion (SBO). This score was elaborated by analyzing clinical, biological and radiological parameters of patients admitted in an emergency center for acute strangulated SBO. Two clinical, two biological and two radiological parameters were shown to significantly predict the surgical outcome of SBO patients.
Since any delay in the management of SBO may result in devastating consequences, a score predicting the severity of the SBO episode is an essential tool for helping in the management of SBO patients. A prospective multicenter validation of the score is mandatory for its extended use.
Read the detailed description
Elaboration of the SBO score:
Intestinal ischaemia as a result of small bowel obstruction (SBO) requires prompt recognition and early intervention. A clinicoradiological score was sought to predict the risk of ischaemia in patients with SBO. A determined protocol for the assessment of patients presenting with SBO was used. A logistic regression model was applied to identify determinant variables and construct a clinical score that would predict ischaemia requiring resection. Of 233 successive patients with SBO, 138 required laparotomy of whom 45 underwent intestinal resection. In multivariable analysis, six variables correlated with small bowel resection and were given one point each towards the clinical score: history of pain lasting more than 4 days, guarding, C-reactive protein level at least 75 mg/l, leucocyte count over 10 G/l, free intraperitoneal fluid volume exceeding 500 ml on computed tomography (CT) and reduction of CT small bowel wall contrast enhancement. The risk of intestinal ischaemia was 6 per cent in patients with a score of 1 or less, whereas 21 of 29 patients with a score of three or more 3 underwent small bowel resection. A positive score of 3 or more had a sensitivity of 67.7 per cent and specificity 90.8 per cent; the area under the receiver operating characteristics curve was 0.87 (95 per cent confidence interval 0.79 to 0.95). By combining clinical, laboratory and radiological parameters, the clinical score allowed early identification of strangulated SBO.
The purpose of the present protocol is to apply the SBO score as a prospective multicenter study. After informed consent, SBO patients corresponding to the inclusion and exclusion criteria will be managed according to the score. Patients with a score of 0 to 2 will be treated conservatively, while a score ≥3 will imply emergency surgery. For its validation, the conservative and surgical outcomes will be compared with the results obtained for the elaboration of the score.
- Conditions
- Intestinal Obstruction
- Being tested
- Conservative treatment versus surgical treatment
- Keywords
- Small bowel occlusion, Conservative treatment for small bowel occlusion, Surgical treatment for small bowel occlusion, Small bowel resection, Score of severity of small bowel occlusion
- Medical subject headings
- Intestinal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative treatment versus surgical treatmentProcedure or surgery
Also called Laparotomy, Adhesiolysis, Small bowel resection
Conservative treatment: starving, nasogastric tube Surgical treatment: open laparotomy, adhesiolysis, with or without small bowel resection
| Study group | Role | What they receive |
|---|---|---|
| SBO score application | Experimental | Acute strangulated SBO patients will receive a severity score at emergency admission. According to the score, they will be managed either conservatively or surgically. During surgery, the need of small bowel resection will be evaluated. The endpoint will be to correlate the type and success of treatment with the score in order to validate this new tool in SBO assessment. Receives: Procedure: Conservative treatment versus surgical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a score of 0-2 with successful conservative treatment
According to the score, patients will be managed either conservatively or surgically. Patients with a score of 0-2 will be treated conservatively. The success of the decision and the treatment will be evaluated after 3 days since admission. Indeed, patients with conservative treatment who do not retrieve a gastrointestinal transit after 3 days will be operated on.
Measured: 3 days
Secondary outcomes (1)
Proportion of patients with a score ≥3 needing small bowel resection
Patients with a score ≥3 will be emergently operated on with a surgical delay below 12 hours since admission. During surgery, segmental small bowel resection will be performed in case of ischemia or necrosis. The need of small bowel resection will be related to the pre-operative score.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2013 (estimated)
- Study completionJul 2013 (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 Intestinal ObstructionStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois
- Investigators
- Frank P Schwenter, MD, PhD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125280
- Sponsor's protocol ID
- NAC 10-009
- Status last verified
- May 2010
- First submitted
- 17 May 2010
- Last updated
- 18 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Wassmer CH, Revol R, Uhe I, Chevallay M, Toso C, Gervaz P, Morel P, Poletti PA, Platon A, Ris F, Schwenter F, Perneger T, Meier RPH. A new clinical severity score for the management of acute small bowel obstruction in predicting bowel ischemia: a cohort study. Int J Surg. 2023 Jun 1;109(6):1620-1628. doi: 10.1097/JS9.0000000000000171.
PubMed 37026805
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter Validation of a Clinicoradiological Score for Predicting the Severity of Strangulated Small Bowel Occlusion
- ClinicalTrials.gov ID
- NCT01125280
- Acronym / sponsor ID
- NAC 10-009
- Conditions
- Intestinal Obstruction
- Keywords
- Small bowel occlusion, Conservative treatment for small bowel occlusion, Surgical treatment for small bowel occlusion, Small bowel resection, Score of severity of small bowel occlusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois
- Study start
- Jul 2010
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 18 May 2010 (estimated)
- 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.
The purpose of this study is to apply and validate a clinicoradiological score for the prediction of severity of strangulated small bowel occlusion (SBO). This score was elaborated by analyzing clinical, biological and radiological parameters of patients admitted in an emergency center for acute strangulated SBO. Two clinical, two biological and two radiological parameters were shown to significantly predict the surgical outcome of SBO patients.
Since any delay in the management of SBO may result in devastating consequences, a score predicting the severity of the SBO episode is an essential tool for helping in the management of SBO patients. A prospective multicenter validation of the score is mandatory for its extended use.
Detailed description
Elaboration of the SBO score:
Intestinal ischaemia as a result of small bowel obstruction (SBO) requires prompt recognition and early intervention. A clinicoradiological score was sought to predict the risk of ischaemia in patients with SBO. A determined protocol for the assessment of patients presenting with SBO was used. A logistic regression model was applied to identify determinant variables and construct a clinical score that would predict ischaemia requiring resection. Of 233 successive patients with SBO, 138 required laparotomy of whom 45 underwent intestinal resection. In multivariable analysis, six variables correlated with small bowel resection and were given one point each towards the clinical score: history of pain lasting more than 4 days, guarding, C-reactive protein level at least 75 mg/l, leucocyte count over 10 G/l, free intraperitoneal fluid volume exceeding 500 ml on computed tomography (CT) and reduction of CT small bowel wall contrast enhancement. The risk of intestinal ischaemia was 6 per cent in patients with a score of 1 or less, whereas 21 of 29 patients with a score of three or more 3 underwent small bowel resection. A positive score of 3 or more had a sensitivity of 67.7 per cent and specificity 90.8 per cent; the area under the receiver operating characteristics curve was 0.87 (95 per cent confidence interval 0.79 to 0.95). By combining clinical, laboratory and radiological parameters, the clinical score allowed early identification of strangulated SBO.
The purpose of the present protocol is to apply the SBO score as a prospective multicenter study. After informed consent, SBO patients corresponding to the inclusion and exclusion criteria will be managed according to the score. Patients with a score of 0 to 2 will be treated conservatively, while a score ≥3 will imply emergency surgery. For its validation, the conservative and surgical outcomes will be compared with the results obtained for the elaboration of the score.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SBO score application | Experimental | Procedure: Conservative treatment versus surgical treatmentAcute strangulated SBO patients will receive a severity score at emergency admission. According to the score, they will be managed either conservatively or surgically. During surgery, the need of small bowel resection will be evaluated. The endpoint will be to correlate the type and success of treatment with the score in order to validate this new tool in SBO assessment. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Strangulated small bowel occlusion
- Diagnosis confirmation by CT-scan with iv contrast
- Blood analysis comprising: leucocyte count and repartition, CRP, lactates
Key exclusion criteria (7 listed)
- Large bowel occlusion
- Strangulated hernia
- Tumor occlusion
- Post-Radiotherapy occlusion
- Paralytic ileus (neurological diseases, diabetes, etc)
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 |
|---|---|---|
| Conservative treatment versus surgical treatmentAlso: Laparotomy, Adhesiolysis, Small bowel resectionConservative treatment: starving, nasogastric tube Surgical treatment: open laparotomy, adhesiolysis, with or without small bowel resection | Procedure or surgery | SBO score application |
Primary outcome
Proportion of patients with a score of 0-2 with successful conservative treatment
Time frame: 3 days
According to the score, patients will be managed either conservatively or surgically. Patients with a score of 0-2 will be treated conservatively. The success of the decision and the treatment will be evaluated after 3 days since admission. Indeed, patients with conservative treatment who do not retrieve a gastrointestinal transit after 3 days will be operated on.
1 secondary outcome
Proportion of patients with a score ≥3 needing small bowel resection
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2010.
- Derived from this study: PubMed 37026805Wassmer CH, Revol R, Uhe I, Chevallay M, Toso C, Gervaz P, Morel P, Poletti PA, Platon A, Ris F, Schwenter F, Perneger T, Meier RPH. A new clinical severity score for the management of acute small bowel obstruction in predicting bowel ischemia: a cohort study. Int J Surg. 2023 Jun 1;109(6):1620-1628. doi: 10.1097/JS9.0000000000000171.
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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. This study is not recruiting at the moment.
Frank P Schwenter, MD, PhD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conservative treatment versus surgical treatment in people with Intestinal Obstruction, run by University Hospital, Geneva at 1 site in Switzerland.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 18 May 2010. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Frank P Schwenter, MD, PhD (+41223727703, frank.schwenter@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with a score of 0-2 with successful conservative treatment (time frame: 3 days). 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 NCT01125280, 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 18 May 2010; AzTrials last refreshed its copy on 7 Nov 2026.