Value of CT-Scan and Oral Gastrografin in the Management of Post Operative Small Bowel Obstruction
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|ClinicalTrials.gov Identifier: NCT00389116|
Recruitment Status : Completed
First Posted : October 18, 2006
Last Update Posted : February 25, 2011
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
|Condition or disease||Intervention/treatment||Phase|
|Small Bowel Obstruction||Drug: gastrograffin Drug: water||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||242 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Value of CT-Scan and Oral Gastrografin in the Management of Post Operative Small Bowel Obstruction|
|Study Start Date :||November 2006|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2010|
|Placebo Comparator: 2||
oral water ingestion
- Need for surgical management [ Time Frame: 2 months ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00389116
|Rouen, France, 76000|
|Principal Investigator:||michel scotté, MD,PhD||CHU Rouen|
|Study Director:||francois mauvais, MD||chg Beauvais|
|Study Director:||jean-marc regimbeau, MD, PhD||CHU amiens|