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| Tracking Information | |||||||||||||
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| First Received Date ICMJE | October 17, 2006 | ||||||||||||
| Last Updated Date | February 17, 2009 | ||||||||||||
| Start Date ICMJE | November 2006 | ||||||||||||
| Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Need for surgical management [ Time Frame: 2 months ] [ Designated as safety issue: Yes ] | ||||||||||||
| Original Primary Outcome Measures ICMJE |
Need for surgical management | ||||||||||||
| Change History | Complete list of historical versions of study NCT00389116 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Value of CT-Scan and Oral Gastrografin in the Management of Post Operative Small Bowel Obstruction | ||||||||||||
| Official Title ICMJE | Value of CT-Scan and Oral Gastrografin in the Management of Post Operative Small Bowel Obstruction | ||||||||||||
| Brief 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. 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 |
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| Detailed Description | |||||||||||||
| Study Phase | Phase IV | ||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Subject), Active Control, Single Group Assignment | ||||||||||||
| Condition ICMJE | Small Bowel Obstruction | ||||||||||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||||||
| Publications * | |||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||
| Estimated Enrollment ICMJE | 242 | ||||||||||||
| Estimated Completion Date | August 2009 | ||||||||||||
| Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 18 Years and older | ||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | France | ||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00389116 | ||||||||||||
| Responsible Party | Scotté, Pr, CHU Rouen | ||||||||||||
| Study ID Numbers ICMJE | 2005/069/HP | ||||||||||||
| Study Sponsor ICMJE | University Hospital, Rouen | ||||||||||||
| Collaborators ICMJE | |||||||||||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Rouen | ||||||||||||
| Verification Date | February 2009 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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