PEG Vs RIG: Percutaneous Endoscopic Gastrostomy Versus Radiologically Inserted Gastrostomy in Children
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Two Interventions (PEG and RIG) Compared Against Each Other
- Sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Complication rate
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •any child referred for gastrostomy insertion
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Complication rate
Time Frame: 3 years
The primary end point of the study will be the total number of complications (major and minor).
Secondary Outcomes
- 1. major complication rate : complications requiring surgery(3 years)
- 2. minor complication rate : complications not requiring surgery(3 years)
- 3.complication score(3 years)
- 4.technical failure(3 yaers)
- 5.difficulty of procedure(3 years)
- 6.cost of hospital treatment(3 years)
- 7.mortality(3 years)
- 8.cause of death(3 years)