A Phase 4 interventional study of gastrograffin and water in Small Bowel Obstruction, sponsored by University Hospital, Rouen. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-02-25.
Sponsored by University Hospital, Rouen · Phase 4, Interventional, and Treatment
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
160 studies on the registry are indexed under Intestinal Obstruction; 27 are open to participants now.
This study's enrollment of 242 is above the median of 80 across 80 interventional studies indexed under Intestinal Obstruction.
Browse Intestinal Obstruction studies →University Hospital, Rouen is the lead sponsor of 410 studies on the registry; 104 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: gastrograffin
Drug: water
ingestion
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
This study is completed, as verified in Feb 2011. You cannot join it, but the record below documents what was studied.
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University Hospital, Rouen