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Type and Title of Submission


Title:

IPG404: Transoral incisionless fundoplication (TIF) in children

Description:

Prospective audited cohort of 20 children showing efficacy (pH objective, QOL subjective, and drugs stopped) and safety of TIF, with a median follow up of 30 months.

Category:

2011-12 Shared Learning Awards

Does the submission relate to the general implementation of all NICE guidance?

No

Does the submission relate to the implementation of a specific piece of NICE guidance?

Yes

Full title of NICE guidance:

IPG404 - Endoscopic threatment for gastro-oesophageal reflux

Category(s) that most closely reflects the nature of the submission:

Is the submission industry-sponsored in any way?

No


Description of submission


Aim

To determine safety and efficacy prospectively of a new endoscopic technique to cure reflux in children.

Objectives

To determine safety and efficacy of this new technique in children suffering with significant gastro-oesophageal reflux.

Context

Laparoscopic fundoplication is expensive, with significant morbidity in children, and efficacy is good but could be better, and the duration of action is variable in growing individuals i.e. children. Opportunities for decreasing cost, hospitilisation, and morbidity, whilst avoiding any scar, and stopping high dose anti-acid medications are provided by this new trans-oral incisionless fundoplication technique, not before used in childhood.

Methods

We trained on the technique, then were given approval to start by our clinical audit and effectiveness committee, then we prospectively audited our cohort of children undergoing this procedure.

Results and evaluation

Validated quality of life score specific to reflux, objective acid study test with pH monitoring, and note of drug cessation were the parameters recorded in a systematic and prospective fashion, using the NICE Audit tool developed for this purpose for this technique. 17/20 children had an excellent result in terms of normalisation of QOL, and reflux index (time below pH 4 over 24 hours as a %, where <6% is normal) diminshed from 15.8% baseline to 5% at 6 months and 8.1% at 12 months, with 9/20 completely normalising. No safety issues were encountered with CO2 insufflation, although the first 2 patients had air insufflation and at a higher pressure some air entered the tissues surrounding the oesophagus requiring antibiotics. When we switched to lower pressure CO2 no adverse events occurred.All children were neurologically normal. Omeprazole dose decreased from 31.5mg/day median to 0.

Key learning points

Prospective audit. Make a good business case also. Train properly and engage with the manufacturers.

View the supporting material

Contact Details

Name:Mike Thomson
Job Title:Consultant Paediatric Gastroenterologist
Organisation:Sheffield Children's Hospital NHS Foundation Trust
Address:Western Bank
Town:Sheffield
County:S Yorkshire
Postcode:S10 2TH
Phone:01142717673
Email:mike.thomson@sch.nhs.uk

 

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This page was last updated: 16 December 2011

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Accessibility | Cymraeg | Freedom of information | Vision Impaired | Contact Us | Glossary | Data protection | Copyright | Disclaimer | Terms and conditions

Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.