Gastrografin for Treating Small Bowel Obstruction in Children
Status:
Recruiting
Trial end date:
2023-08-31
Target enrollment:
Participant gender:
Summary
This is a multi-centre clustered open label clinical trial testing the effectiveness of
adding Gastrografin to standard non-surgical management of small bowel obstruction.
Gastrografin is a radiopaque contract agent that exhibits a mild laxative effective due to
its high osmolarity and ability to pull water into the intestines and bowels as a lubricant.
Small bowel obstruction is a mechanical or function obstruction that prevents normal bowel
function. The standard treatment for small bowel obstruction is non-surgical and includes
decompressing the abdomen, fluid resuscitation, nothing by mouth, and time. In some cases if
non-surgical management is not effective in resolving the obstruction, surgical intervention
is required. Gastrografin in addition to standard non-surgical management has been shown to
reduce the rate of surgery, length of hospital stay, and time to resolution in similar
clinical scenarios, such as meconium ileus and meconium plug syndrome. However, it has never
been tested in children with small bowel obstruction. This study is a clustered open label
study, meaning that each participating centre will select the type of treatment they will
offer at their centre. The treatment options are either the Gastrografin arm (a single dose
of Gastrografin plus non-surgical management) or the Control arm (a single dose of saline
solution plus non-surgical management). After each group receives saline or Gastrografin they
will continue with the same non-surgical treatment that patients not participating in the
trial would receive. Participating in the study does not preclude the need for urgent or
emergent surgical intervention and at any point in the study, if the patient requires surgery
for their small bowel obstruction they will undergo surgical intervention. The outcomes of
this study are the rate of surgical intervention, length of stay, time to first and full
feeds, and rate of complications.