Intra-operative balloon dilatation of the pylorus in oesophagogastrectomy
| ISRCTN | ISRCTN45833259 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45833259 |
| Protocol serial number | N0051127200 |
| Sponsor | Department of Health |
| Funder | Brighton and Sussex University Hospitals NHS Trust (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
1. Contrast swallow score |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| 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
- United Kingdom
- England
Study participating centre
Brighton & Sussex University Hospitals NHS Trust (RSCH)
Brighton
BN2 5BE
United Kingdom
BN2 5BE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
16/03/2016: No publications found, verifying study status with principal investigator.