Two Interventions (PEG and RIG) Compared Against Each Other Clinical Trial
Official title:
PEG Vs RIG: Percutaneous Endoscopic Gastrostomy Versus Radiologically Inserted Gastrostomy in Children
A gastrostomy is a feeding tube that communicates from the skin directly into the stomach.
It is a device frequently used in children that have feeding difficulties or are unable to
maintain normal growth via oral feeds. The same device may be inserted in two ways: the
percutaneous endoscopic method (PEG) which is guided by the use of an endoscope (flexible
camera), or the radiologically inserted method (RIG) which is guided by the use of X-ray
imaging. Both methods of insertion have been used in children for more than 20 years, but it
is not clear which is the best method. Both methods are associated with complications,
including injury to other abdominal organs and leakage leading to sepsis. There are no
randomised controlled trials comparing the two techniques.
We aim to compare the outcome of both methods of gastrostomy insertion in children, with
emphasis on the complication rates. We have devised a complication score with weightage
assigned to each complication according to its severity.
A randomised controlled trial will be performed in children requiring a gastrostomy, 100 per
group. The primary outcome will be the overall total complication rate.
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care