A randomised controlled study of patients seen in a special nurse-led clinic after gastroscopy investigation for symptoms related to indigestion

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN08109872

Enrollment

186

Registered

2008-04-02

Start date

2003-02-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroscopy Digestive System gastroscopy

Interventions

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 coll

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 s

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 interve

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

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

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026