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

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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
Sponsor:
Information provided by (Responsible Party):
Great Ormond Street Hospital for Children NHS Foundation Trust

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.


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
Experimental: PEG
Percutaneous Endoscopic Gastrostomy
Procedure: Percutaneous Endoscopic Gastrostomy
PEG

Experimental: RIG
Radiologically-guided Insertion of Gastrostomy
Procedure: Radiologically-guided insertion of Gastrostomy
RIG




Primary Outcome Measures :
  1. Complication rate [ Time Frame: 3 years ]
    The primary end point of the study will be the total number of complications (major and minor).


Secondary Outcome Measures :
  1. 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. 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. 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. 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. 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. 6.cost of hospital treatment [ Time Frame: 3 years ]
  7. 7.mortality [ Time Frame: 3 years ]
  8. 8.cause of death [ Time Frame: 3 years ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920438


Contacts
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Contact: Rashmi R Singh, MBBS, MRCS 02079052682 rashmi.singh@ucl.ac.uk

Locations
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United Kingdom
Great Ormond Street Hospital Recruiting
London, United Kingdom, WC1N 3JH
Contact: Rashmi R Singh, MBBS, MRCS    +44 2079052682    rashmi.singh@ucl.ac.uk   
Principal Investigator: Joe I Curry, FRCS(Eng),FRCS(Paed Surg)         
Sponsors and Collaborators
Great Ormond Street Hospital for Children NHS Foundation Trust
Investigators
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Study Chair: Joe I Curry, MBBS,FRCS(Eng),FRCS(Paed Surg) Great Ormond Street Hospital Great Ormond Street, London, WC1N 3JHLondon

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Great Ormond Street Hospital for Children NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01920438     History of Changes
Other Study ID Numbers: 10SG14
First Posted: August 12, 2013    Key Record Dates
Last Update Posted: August 12, 2013
Last Verified: August 2013

Keywords provided by Great Ormond Street Hospital for Children NHS Foundation Trust:
Percutaneous endoscopic gastrostomy,
Radiologically inserted gastrostomy,
Complications