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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
200
PEG
RIG
Great Ormond Street Hospital
London, United Kingdom
RECRUITINGComplication rate
The primary end point of the study will be the total number of complications (major and minor).
Time frame: 3 years
1. major complication rate : complications requiring surgery
Colonic injury or gastro-colic fistula or other visceral injury, peritonitis requiring surgery, intestinal obstruction requiring surgery, major gastrointestinal bleed, other complications requiring surgery
Time frame: 3 years
2. minor complication rate : complications not requiring surgery
Infection requiring systemic antibiotics, delay more than 48 hours in establishing feeds, granulation, wound site discharge, tube-related problems (migration, dislodgement, leakage, breakage), other minor
Time frame: 3 years
3.complication score
This is a score devised with weighting assigned to each complication depending on the severity of the complication.The score was devised in a consensus meeting attended by experts in the field (paediatric surgeons, interventional radiologists, junior doctors and nurses.
Time frame: 3 years
4.technical failure
These are the number of PEG or RIG that are unsuccessful and require conversion to open surgical gastrostomy or laparoscopic gastrostomy.
Time frame: 3 yaers
5.difficulty of procedure
Assessed by the operator as : 1) easy, 2) slightly difficult (but does not warrant conversion), 3) difficult (warrants conversion)
Time frame: 3 years
6.cost of hospital treatment
Time frame: 3 years
7.mortality
Time frame: 3 years
8.cause of death
Time frame: 3 years
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