The use of fibreoptic bronchoscopy in improving the outcome of surgery in patients with upper gastrointestinal (GI) cancer
ISRCTN | ISRCTN11257300 |
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DOI | https://doi.org/10.1186/ISRCTN11257300 |
Secondary identifying numbers | N0025121734 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 15/04/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Ramita Dey
Scientific
Scientific
General Surgery
University Hospital Aintree
Longmoor Lane
Liverpool
L9 7AL
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | The use of fibreoptic bronchoscopy in improving the outcome of surgery in patients with upper gastrointestinal (GI) cancer |
Study objectives | The use of fibreoptic bronchoscopy in improving the outcome of surgery in patients with upper GI cancer |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | Cancer: Gastrointestinal |
Intervention | Group 1: Postoperative awake flexible bronchoscopy will be carried out on ITU on days 1 and 2. Continuous monitoring of respiratory rate, heart rate, peripheral blood oxygen saturation and arterial blood pressure will be carried out during bronchoscopy. Equipment and expertise for endotracheal intubation will be available and used if patients experience significant deterioration in cardiovascular or respiratory function during procedure. All major and segmental bronchi will be inspected, toileting will be performed with suction and lavage. Protected brudh samples taken for microbiology and semiquantitative analysis of specimens performed. In case of extensive secretions bronchoscopy will be repeated after day 2 as required. During procedure incidence of early postextubation injury to larynx, incidence of iatrogenic trauma to distal airways and recurrent laryngeal nerve injury also assessed. Photographs recorded during bronchoscopy. Postprocedure lung function - forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio and peak flow will be assessed by spirometry and peak flow meter on days 1, 3, 5 and 8. Arterial blood gas analysis done days 1, 3 and 5. Temperature recorded daily. White cell count recorded days 1, 3 and 5. Group 2: Best conventional treatment including epidural analgesia, humidified oxygen by mask and regular physiotherapy to clear secretions. Bronchoscopy will be undertaken in controlled subjects if clinically indicated. |
Intervention type | Other |
Primary outcome measure | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/03/2003 |
Completion date | 01/03/2005 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Not Specified |
Target number of participants | 80 |
Key inclusion criteria | 80 adult patients with upper GI cancer |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/03/2003 |
Date of final enrolment | 01/03/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University Hospital Aintree
Liverpool
L9 7AL
United Kingdom
L9 7AL
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Website | http://www.doh.gov.uk |
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Funders
Funder type
Government
Aintree Hospitals NHS Trust (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |