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Quality of life measures in Barrett's Oesophagus care pathways

Assessing the patient impact and burden of current care pathways in Barrett’s Oesophagus

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN76017289
Enrollment
750
Registered
2017-11-01
Start date
2018-01-01
Completion date
Unknown
Last updated
2023-01-09

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

Conditions

Specialty: Gastroenterology, Primary sub-specialty: Gastroenterology

Interventions

This clinical research will be divided into 3 sections for the purposes of data collection and analysis: 1. Assessing Health Related Quality of Life in Barrett’s Oesophagus (Cohort St
-Normal healthy individuals. (1 questionnaire) -Gastroesophageal Reflux Disease without BO. (1 questionnaire) -Colonic adenoma surveillance. (1 questionnaire)

Sponsors

Wrightington, Wigan And Leigh NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Must have capacity to give informed consent 2. >18 years old. No upper age limit. 3. Male or Female 4. Meet the diagnostic criteria for each group 4.1. Non-Dysplastic Barrett’s Oesophagus. All patients enrolled in surveillance who have been given a diagnosis of BO irrespective of current histology (lack of intestinal metaplasia on latest biopsies is not a criterion for exclusion providing future surveillance is indicated/recommended) 4.2. Barrett’s oesophagus with dysplasia or early oesophageal adenocarcinoma. Any patient with BO diagnosed with low grade dysplasia, high grade dysplasia or early OAC eligible for ET. 4.3. Colonic Polyps. Participants currently undergoing endoscopic surveillance for colonic polyps 4.4. Gastro-oesophageal reflux disease. Participants without BO who have been diagnosed with any of the following; “gastroesophageal reflux + oesophagitis”, “gastroesophageal reflux – oesophagitis”, “gastroesophageal reflux disease”, “GORD”, “acid reflux” or “heartburn”, “dyspepsia”. 4.5. Normal Healthy Individuals. Population control participants who do not exhibit significant co-morbidities

Exclusion criteria

Exclusion criteria: 1. Lack capacity to consent 2. <18 years old

Design outcomes

Primary

MeasureTime frame
1. Health related quality of life is measured using a self-administered questionnaire as a one off assessment in all groups and at baseline and between 4-12 months in the Barrett’s oesophagus with dysplasia group. 2. Follow up needs and patient burdens are measured using semi-structured in-depth patient interviews 2.1 Health related quality of life is measured using a self-administered questionnaire after intervention (clinic arms), after endoscopy (non-clinic arm) and then 4 and 6 months later (all arms)

Secondary

MeasureTime frame
There are no secondary outcome measures.

Countries

England, United Kingdom

Contacts

Public ContactYeng Ang
Yeng.Ang@srft.nhs.uk+44 161789 7373

Outcome results

None listed

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