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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG | Experimental | Percutaneous Endoscopic Gastrostomy |
|
| RIG | Experimental | Radiologically-guided Insertion of Gastrostomy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Percutaneous Endoscopic Gastrostomy | Procedure | PEG |
| |
| Radiologically-guided insertion of Gastrostomy |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rashmi R Singh, MBBS, MRCS | Contact | 02079052682 | rashmi.singh@ucl.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| Joe I Curry, MBBS,FRCS(Eng),FRCS(Paed Surg) | Great Ormond Street Hospital Great Ormond Street, London, WC1N 3JHLondon | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Great Ormond Street Hospital | Recruiting | London | WC1N 3JH | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20620311 | Background | 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. | |
| 28940403 | Derived | Singh RR, Nah SA, Roebuck DJ, Eaton S, Pierro A, Curry JI; PEG-RIG trial collaborators. Double-blind randomized clinical trial of percutaneous endoscopic gastrostomy versus radiologically inserted gastrostomy in children. Br J Surg. 2017 Nov;104(12):1620-1627. doi: 10.1002/bjs.10687. Epub 2017 Sep 20. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 7, 2021 | |
| Reset | Feb 24, 2022 |
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| Procedure |
RIG |
|
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 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 7, 2021 | Feb 24, 2022 |