Shared learning database

 
Organisation:
Sheffield Children's Hospital NHS Foundation Trust
Published date:
December 2011

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.

Guidance the shared learning relates to:
Does the example relate to a general implementation of all NICE guidance?
No
Does the example relate to a specific implementation of a specific piece of NICE guidance?
Yes

Example

Aims and objectives

To determine safety and efficacy prospectively of a new endoscopic technique to cure reflux in children. To determine safety and efficacy of this new technique in children suffering with significant gastro-oesophageal reflux.

Reasons for implementing your project

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.

How did you implement the project

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.

Key findings

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.

Contact details

Name:
Mike Thomson
Job:
Consultant Paediatric Gastroenterologist
Organisation:
Sheffield Children's Hospital NHS Foundation Trust
Email:
mike.thomson@sch.nhs.uk

Sector:
Tertiary care
Is the example industry-sponsored in any way?
No