Outcome Study of Endoscopically Inserted Gastrostomy (PEG)Versus Radiologically-guided Insertion of Gastrostomy (RIG)in Children (PEG Vs RIG)
|ClinicalTrials.gov Identifier: NCT01920438|
Recruitment Status : Unknown
Verified August 2013 by Great Ormond Street Hospital for Children NHS Foundation Trust.
Recruitment status was: Recruiting
First Posted : August 12, 2013
Last Update Posted : August 12, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Two Interventions (PEG and RIG) Compared Against Each Other||Procedure: Percutaneous Endoscopic Gastrostomy Procedure: Radiologically-guided insertion of Gastrostomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||PEG Vs RIG: Percutaneous Endoscopic Gastrostomy Versus Radiologically Inserted Gastrostomy in Children|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||August 2014|
|Estimated Study Completion Date :||August 2017|
Percutaneous Endoscopic Gastrostomy
Procedure: Percutaneous Endoscopic Gastrostomy
Radiologically-guided Insertion of Gastrostomy
Procedure: Radiologically-guided insertion of Gastrostomy
- Complication rate [ Time Frame: 3 years ]The primary end point of the study will be the total number of complications (major and minor).
- 1. major complication rate : complications requiring surgery [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3 years ]
- 7.mortality [ Time Frame: 3 years ]
- 8.cause of death [ Time Frame: 3 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920438
|Contact: Rashmi R Singh, MBBS, MRCSfirstname.lastname@example.org|
|Great Ormond Street Hospital||Recruiting|
|London, United Kingdom, WC1N 3JH|
|Contact: Rashmi R Singh, MBBS, MRCS +44 2079052682 email@example.com|
|Principal Investigator: Joe I Curry, FRCS(Eng),FRCS(Paed Surg)|
|Study Chair:||Joe I Curry, MBBS,FRCS(Eng),FRCS(Paed Surg)||Great Ormond Street Hospital Great Ormond Street, London, WC1N 3JHLondon|