Contact information
Type
Scientific
Primary contact
Dr Donald Manifold
ORCID ID
Contact details
Brighton & Sussex University Hospitals NHS Trust (RSCH)
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom
+44 (0)1273 696955
donald.manifold@bsuh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0051127200
Study information
Scientific title
Intra-operative balloon dilatation of the pylorus in oesophagogastrectomy
Acronym
Study hypothesis
To determine if routine intra-operative balloon dilatation of the pylorus eliminates delayed gastric emptying and may therefore be a feasible alternative to pyloroplasty/pyloromyotomy.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Oesophagogastrectomy
Intervention
Randomised Controlled Trial to determine if routine intra-operative balloon dilatation of the pylorus eliminates delayed gastric emptying and may therefore be a feasible alternative to pyloroplasty/pyloromyotomy.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
1. Contrast swallow score
2. Symptom score
3. Weight gain
4. Duodenogastric reflux
5. Oesophageal acid reflux
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/2003
Overall trial end date
31/03/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Patients undergoing oesophagogastrectomy
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/04/2003
Recruitment end date
31/03/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Brighton & Sussex University Hospitals NHS Trust (RSCH)
Brighton
BN2 5BE
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Brighton and Sussex University Hospitals NHS Trust (UK)
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