Outcome Study of Endoscopically Inserted Gastrostomy (PEG)Versus Radiologically-guided Insertion of Gastrostomy (RIG)in Children

Study Overview
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Brief Summary
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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.

Official Title
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PEG Vs RIG: Percutaneous Endoscopic Gastrostomy Versus Radiologically Inserted Gastrostomy in Children

Conditions
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Two Interventions (PEG and RIG) Compared Against Each Other

Intervention / Treatment
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* Procedure: Percutaneous Endoscopic Gastrostomy
* Procedure: Radiologically-guided insertion of Gastrostomy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEG<br>Percutaneous Endoscopic Gastrostomy | Procedure: Percutaneous Endoscopic Gastrostomy<br>* PEG<br>|
| Experimental: RIG<br>Radiologically-guided Insertion of Gastrostomy | Procedure: Radiologically-guided insertion of Gastrostomy<br>* RIG<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate | The primary end point of the study will be the total number of complications (major and minor). | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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. | 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. | 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) | 3 years | 
| 6.cost of hospital treatment |  | 3 years | 
| 7.mortality |  | 3 years | 
| 8.cause of death |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous endoscopic gastrostomy,, Radiologically inserted gastrostomy,, Complications