Small Bowel ObstructionPhase 4NCT00389116
Value of CT-Scan and Oral Gastrografin in the Management of Post Operative Small Bowel Obstruction
A Phase 4 study testing gastrograffin and water in people with Small Bowel Obstruction, run by University Hospital, Rouen at 1 site in France.
Trial summary
Small bowel obstructions are responsible for 2 to 5% of emergency hospital admissions and 20% of all emergency surgical procedures. In 60 to 80% of cases, acute small bowel obstructions are the consequence of intraperitoneal postoperative adhesions. 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?
- gastrograffin and water
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 242 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2006to Aug 2010
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Small bowel obstruction in patients with previous abdominal surgery
Who cannot join
- Age less than 18 years
- Early small bowel obstruction (less than 4 weeks following abdominal surgery)
- Small bowel obstruction in the course of digestive cancer.
- Hyperthermic small bowel obstruction
- Small bowel ischemia (fever, peritoneal signs, increased leucocytosis)
- Pregnancy ( Elevated béta HCG levels)
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- Inflammatory bowel disease
- Previous abdominal radiotherapy
- Pneumoperitoneum
- Colorectal obstruction
Trial locations and contacts
1 site in 1 country.
About this study
Small bowel obstructions are responsible for 2 to 5% of emergency hospital admissions and 20% of all emergency surgical procedures. In 60 to 80% of cases, acute small bowel obstructions are the consequence of intraperitoneal postoperative adhesions. They constitute an extremely frequent pathology, leading to a high rate of hospital admissions and money expense.
Management of small bowel obstruction is based on 2 options: either a surgical approach where all patients are operating on, or a conservative treatment in which surgery is proposed in case of failure of medical treatment. The surgical approach leads to operate on an excessive rate of patients while the medical approach increases the risk of increased small bowel resection, morbidity rate or hospitalization duration.
Read more
In order to improve the management of small bowel obstruction, it seems necessary to better distinguish patients that need an emergency surgical procedure from patients in which medical treatment will be useful. Many studies have been performed to investigate the value of imaging in the management of small bowel obstruction, using abdominal X-ray, oral gastrografin administration or CT-Scan.
The aim of this study is to analyse the effect of a systematic performance of imaging investigation on the management of patients presenting with a postoperative small bowel obstruction.
All patients suffering from a postoperative small bowel obstruction will be included in this study. They will be randomised in 2 groups. In group S, patients will have CT-Scan and oral water administration while in group SG, Patients will have CT-Scan and oral gastrografin administration The major end point of this study is to analyse whether imaging examination can reduce the need for a surgical approach or the rate of small bowel resection and to determine its influence on fasting time or hospitalization duration
- Conditions
- Small Bowel Obstruction
- Being tested
- gastrograffin, water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gastrograffinDrug
ingestion
waterDrug
oral water ingestion
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: gastrograffin |
| 2 | Placebo comparator | Not described Receives: Drug: water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for surgical management
Measured: 2 months
Secondary outcomes (6)
Sensibility and specificity of gastrografin oral administration
Measured: 2 months
Sensibility and specificity of CT-Scan.
Measured: 2 months
Sensibility and specificity of abdominal X-ray.
Measured: 2 months
Fasting time
Measured: 2 months
Hospitalization time
Measured: 2 months
Number of small bowel resection
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2006 (estimated)
- Study startNov 2006
- Primary completionAug 2009
- Study completionAug 2010
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.
- More trials run by University Hospital, RouenThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Investigators
- michel scotté, MD,PhD, Principal investigator, CHU Rouenfrancois mauvais, MD, Study director, chg Beauvaisjean-marc regimbeau, MD, PhD, Study director, CHU amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00389116
- Sponsor's protocol ID
- 2005/069/HP
- Status last verified
- Feb 2011
- First submitted
- 17 Oct 2006
- Last updated
- 25 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cosse C, Regimbeau JM, Fuks D, Mauvais F, Scotte M. Serum procalcitonin for predicting the failure of conservative management and the need for bowel resection in patients with small bowel obstruction. J Am Coll Surg. 2013 May;216(5):997-1004. doi: 10.1016/j.jamcollsurg.2012.12.051. Epub 2013 Mar 19.
PubMed 23522439
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of CT-Scan and Oral Gastrografin in the Management of Post Operative Small Bowel Obstruction
- ClinicalTrials.gov ID
- NCT00389116
- Acronym / sponsor ID
- 2005/069/HP
- Conditions
- Small Bowel Obstruction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 18 Oct 2006 (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.
Small bowel obstructions are responsible for 2 to 5% of emergency hospital admissions and 20% of all emergency surgical procedures. In 60 to 80% of cases, acute small bowel obstructions are the consequence of intraperitoneal postoperative adhesions. They constitute an extremely frequent pathology, leading to a high rate of hospital admissions and money expense.
Management of small bowel obstruction is based on 2 options: either a surgical approach where all patients are operating on, or a conservative treatment in which surgery is proposed in case of failure of medical treatment. The surgical approach leads to operate on an excessive rate of patients while the medical approach increases the risk of increased small bowel resection, morbidity rate or hospitalization duration.
In order to improve the management of small bowel obstruction, it seems necessary to better distinguish patients that need an emergency surgical procedure from patients in which medical treatment will be useful. Many studies have been performed to investigate the value of imaging in the management of small bowel obstruction, using abdominal X-ray, oral gastrografin administration or CT-Scan.
The aim of this study is to analyse the effect of a systematic performance of imaging investigation on the management of patients presenting with a postoperative small bowel obstruction.
All patients suffering from a postoperative small bowel obstruction will be included in this study. They will be randomised in 2 groups. In group S, patients will have CT-Scan and oral water administration while in group SG, Patients will have CT-Scan and oral gastrografin administration The major end point of this study is to analyse whether imaging examination can reduce the need for a surgical approach or the rate of small bowel resection and to determine its influence on fasting time or hospitalization duration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: gastrograffin |
| 2 | Placebo comparator | Drug: water |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Small bowel obstruction in patients with previous abdominal surgery
Key exclusion criteria (10 listed)
- Age less than 18 years
- Early small bowel obstruction (less than 4 weeks following abdominal surgery)
- Small bowel obstruction in the course of digestive cancer.
- Hyperthermic small bowel obstruction
- Small bowel ischemia (fever, peritoneal signs, increased leucocytosis)
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 |
|---|---|---|
| gastrograffiningestion | Drug | 1 |
| wateroral water ingestion | Drug | 2 |
Primary outcome
Need for surgical management
Time frame: 2 months
6 secondary outcomes
Sensibility and specificity of gastrografin oral administration
Time frame: 2 months
Sensibility and specificity of CT-Scan.
Time frame: 2 months
Sensibility and specificity of abdominal X-ray.
Time frame: 2 months
Fasting time
Time frame: 2 months
Hospitalization time
Time frame: 2 months
Number of small bowel resection
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2011.
- Derived from this study: PubMed 23522439Cosse C, Regimbeau JM, Fuks D, Mauvais F, Scotte M. Serum procalcitonin for predicting the failure of conservative management and the need for bowel resection in patients with small bowel obstruction. J Am Coll Surg. 2013 May;216(5):997-1004. doi: 10.1016/j.jamcollsurg.2012.12.051. Epub 2013 Mar 19.
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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.
michel scotté, MD,PhD principal investigator
CHU Rouen
francois mauvais, MD study director
chg Beauvais
jean-marc regimbeau, MD, PhD study director
CHU amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing gastrograffin and water in people with Small Bowel Obstruction, run by University Hospital, Rouen 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 1 inclusion and 10 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: finished, as of the sponsor's last update on 25 Feb 2011. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Need for surgical management (time frame: 2 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 NCT00389116, 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 25 Feb 2011.