Two Interventions (PEG and RIG) Compared Against Each Other Clinical Trial
— PEG Vs RIGOfficial 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.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | August 2017 |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Great Ormond Street Hospital | London |
| Lead Sponsor | Collaborator |
|---|---|
| Great Ormond Street Hospital for Children NHS Foundation Trust |
United Kingdom,
Nah SA, Narayanaswamy B, Eaton S, Coppi PD, Kiely EM, Curry JI, Drake DP, Barnacle AM, Roebuck DJ, Pierro A. Gastrostomy insertion in children: percutaneous endoscopic or percutaneous image-guided? J Pediatr Surg. 2010 Jun;45(6):1153-8. doi: 10.1016/j.jpedsurg.2010.02.081. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Complication rate | The primary end point of the study will be the total number of complications (major and minor). | 3 years | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 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 | No |
| Secondary | 6.cost of hospital treatment | 3 years | No | |
| Secondary | 7.mortality | 3 years | No | |
| Secondary | 8.cause of death | 3 years | No |