Condition category
Digestive System
Date applied
27/02/2008
Date assigned
02/04/2008
Last edited
02/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Praful Patel

ORCID ID

Contact details

Southampton University Hospital NHS Trust
Department of Gastroenterology
Level D
West wing
Southampton
SO16 6YD
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RHM MED0719

Study information

Scientific title

A randomised controlled trial of structured nurse-led clinic follow-up for dyspeptic patients after direct access gastroscopy

Acronym

Study hypothesis

The aim is to study patients with a confirmed endoscopic diagnosis of the following:
1. Mild gastro oesophageal reflux disease (non-erosive and mild oesophagitis)
2. Hiatus hernia (any size)
3. Non-ulcer dyspepsia (normal findings, mild or moderate gastritis and duodenitis)

Study hypothesis:
An experienced gastrointestinal nurse practitioner providing structured patient-centred advice at follow-up clinic after gastroscopy to patients with mild dyspepsia, would reduce drug costs without adversely affecting symptoms relief or quality of life.

Ethics approval

Southampton & South West Hampshire Research Ethics Committees (B). Date of approval: 22nd March 2002 (REC reference: 050/02)

Study design

Single-centre, randomised, placebo-controlled trial.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Gastroscopy

Intervention

This is a randomised placebo-controlled trial with concealed allocation (random number table) of study cohorts. Post-intervention assessor is blinded to diagnosis and study status.

Baseline data collection:
1. Demography
2. Body mass index (BMI)
3. Social habit status
4. Ulcer healing drugs (UHD; Histamine 2 antagonist, proton pump inhibitor) used in the 6 months before investigation
5. Glasgow dyspepsia severity score (GLADYS)
6. Health related general well being (12-item short form health survey [SF-12])

After gastroscopy, eligible patients are randomised to either normal (control) practice (return to GP for follow-up treatment) or intervention (to nurse follow-up).

The nurse-led clinic last for 35 minutes and a full medical history is taken. The clinical management is based on national and local guidelines, with reference to findings as well as patients' predominant symptoms. Counselling and lifestyle advice, including bespoke information leaflets given and treatment concordance agreed; further investigation may be initiated if required. For consistency and reproducibility 'History taking' and 'Lifestyle advice' proformas are devised for use. Clinic letter with information on intervention and treatment recommendations is sent to patients' GP after consultation.

Six months after gastroscopy all patients are contacted by telephone for reassessment of the following:
1. Weight
2. GLADYS
3. SF-12
4. UHD used in the six months after gastroscopy
5. Usefulness of post-investigation follow-up

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The difference between the nurse group and GP group after intervention in:
1. GLADYS: 8 questions and a total low score equals to least symptoms with a minimum of 0 and maximum 20
2. SF-12: Six questions (3 have 2 parts and 1 has 4 parts). A total high score in this measurement denotes better health related general well being with a minimum 0 and maximum 900
3. UHD costs 6 months before and after gastroscopy. The UHD cost analysis is based on the price listed in the Drug Tariff (generic items) or MIMS (branded items). They are summed according to class and averaged.

Secondary outcome measures

Compares before and after intervention within same group in:
1. GLADYS
2. SF-12
3. UHD costs

Overall trial start date

01/02/2003

Overall trial end date

28/02/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and female patients with dyspepsia
2. Over 18 years old
3. Undergoing direct access gastroscopy

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

186

Participant exclusion criteria

There are 2 stages of filtering for exclusion as follows:
1. Before gastroscopy - From referral letters/forms patients with sinister symptoms:
1.1. Anaemia
1.2. Weight loss over half a stone in three months
1.3. Haematemesis
1.4. Dysphagia
1.5. Vomiting
2. After gastroscopy:
2.1. Peptic ulcer
2.2. Tumour
2.3. Severe oesophagitis
2.4. Barrett's oesophagus
2.5. Anatomical abnormality and
2.6. Post-operative stomach

Recruitment start date

01/02/2003

Recruitment end date

28/02/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southampton University Hospital NHS Trust
Southampton
SO16 6YD
United Kingdom

Sponsor information

Organisation

Southampton University Hospitals NHS Trust (UK)

Sponsor details

Research and Development Department
Trust Management Office
Mailpoint 18
Treamona Road
Southampton
SO16 6YD
United Kingdom

Sponsor type

Government

Website

http://www.suht.nhs.uk

Funders

Funder type

Other

Funder name

This study was investigator-funded with the agreement of the Southampton University Hospital NHS Trust that secretarial and out-patient work force can be utilised as long as it is planned into routine work.

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/16531518

Publication citations

  1. Results

    British Society of Gastroenterology Annual Meeting, 20-23 March 2006, Birmingham, England, United Kingdom. Abstracts., Gut, 2006, 55 Suppl 2, A1-119.

Additional files

Editorial Notes