Intra-operative balloon dilatation of the pylorus in oesophagogastrectomy
| ISRCTN | ISRCTN45833259 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45833259 |
| Secondary identifying numbers | N0051127200 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 16/03/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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
Dr Donald Manifold
Scientific
Scientific
Brighton & Sussex University Hospitals NHS Trust (RSCH)
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom
| Phone | +44 (0)1273 696955 |
|---|---|
| donald.manifold@bsuh.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Intra-operative balloon dilatation of the pylorus in oesophagogastrectomy |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/04/2003 |
| Completion date | 31/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Patients undergoing oesophagogastrectomy |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/04/2003 |
| Date of final enrolment | 31/03/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Brighton & Sussex University Hospitals NHS Trust (RSCH)
Brighton
BN2 5BE
United Kingdom
BN2 5BE
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Hospital/treatment centre
Brighton and Sussex University Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| 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 |
Editorial Notes
16/03/2016: No publications found, verifying study status with principal investigator.
