Outcome Study of Endoscopically Inserted Gastrostomy (PEG)Versus Radiologically-guided Insertion of Gastrostomy (RIG)in Children
- Conditions
- Two Interventions (PEG and RIG) Compared Against Each Other
- Interventions
- Procedure: Percutaneous Endoscopic GastrostomyProcedure: Radiologically-guided insertion of Gastrostomy
- Registration Number
- NCT01920438
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 200
- any child referred for gastrostomy insertion
- the child has gastro-esophageal reflux and is being considered for anti-reflux surgery
- previous gastrostomy or fundoplication
- previous extensive abdominal surgery
- the child requires a concomitant major procedure on the gut or other intra- abdominal organs
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PEG Percutaneous Endoscopic Gastrostomy Percutaneous Endoscopic Gastrostomy RIG Radiologically-guided insertion of Gastrostomy Radiologically-guided Insertion of Gastrostomy
- Primary Outcome Measures
Name Time Method Complication rate 3 years The primary end point of the study will be the total number of complications (major and minor).
- Secondary Outcome Measures
Name Time Method 1. major complication rate : complications requiring surgery 3 years Colonic injury or gastro-colic fistula or other visceral injury, peritonitis requiring surgery, intestinal obstruction requiring surgery, major gastrointestinal bleed, other complications requiring surgery
2. minor complication rate : complications not requiring surgery 3 years 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
3.complication score 3 years 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.
4.technical failure 3 yaers These are the number of PEG or RIG that are unsuccessful and require conversion to open surgical gastrostomy or laparoscopic gastrostomy.
5.difficulty of procedure 3 years Assessed by the operator as : 1) easy, 2) slightly difficult (but does not warrant conversion), 3) difficult (warrants conversion)
6.cost of hospital treatment 3 years 7.mortality 3 years 8.cause of death 3 years
Trial Locations
- Locations (1)
Great Ormond Street Hospital
🇬🇧London, United Kingdom