drugset / Trial / NCT00601809

(Gastrografin Use in Small Bowel Obstruction Caused by Adherences)

NCT00601809 ↗

Phase 4 Completed 76 enrolled University of Bologna
RandomizedParallel-groupOpen-labelTreatment

Summary

Adhesive small intestine obstruction (ASIO) is an important cause of hospital admission and a very common disease. Any improvement in this field will benefit many patients by reducing the operative rate. Patients with this disease are difficult to evaluate and to manage and their treatment is controversial. Emergency surgery is mandatory when strangulation is suspected or in the case of total obstruction. On the other hand, conservative non-operative treatment is indicated in the case of partial obstruction. The role of water-soluble contrast medium (Gastrografin®: GG) in ASIO is still debated with regard to the therapeutic value. The aim of our study was to determine the therapeutic role of Gastrografin in patients with small intestine obstruction without strangulation caused by adherences (ASIO).

Timeline

Start
2003-09
Primary completion
—
Completion
2006-11

Outcome

Met primary endpoint

paper The difference in the operative rate between the two treatment groups reached statistical significance (p = 0.013). PMID 18688562 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Gastrografin Diagnostic / imaging agent — Oral