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

Brighton & Sussex University Hospitals NHS Trust (RSCH)
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom

Phone +44 (0)1273 696955
Email donald.manifold@bsuh.nhs.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific titleIntra-operative balloon dilatation of the pylorus in oesophagogastrectomy
Study objectivesTo 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) studiedOesophagogastrectomy
InterventionRandomised 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 typeProcedure/Surgery
Primary outcome measure(s)

1. Contrast swallow score
2. Symptom score
3. Weight gain
4. Duodenogastric reflux
5. Oesophageal acid reflux

Key secondary outcome measure(s)

Not provided at time of registration

Completion date31/03/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Key inclusion criteriaPatients undergoing oesophagogastrectomy
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment01/04/2003
Date of final enrolment31/03/2005

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Brighton & Sussex University Hospitals NHS Trust (RSCH)
Brighton
BN2 5BE
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Editorial Notes

16/03/2016: No publications found, verifying study status with principal investigator.