Prophylactic Balloon Dilatation During Ivor Lewis Oesophagectomy

• Research type

  Research Study

• Full title

  Randomised controlled trial (feasibility study) of prophylactic pyloric balloon dilatation during Ivor Lewis oesophagectomy to prevent delayed gastric emptying

• IRAS ID

  287659

• Contact name

  David Chan

• Contact email

  david.chan8@nhs.net

• Sponsor organisation

  University Hospitals Plymouth NHS Trust

• Duration of Study in the UK

  0 years, 10 months, 31 days

• Research summary

  Study Title: Randomised controlled trial (feasibility study) of prophylactic pyloric balloon dilatation during Ivor Lewis oesophagectomy to prevent delayed gastric emptying

  Study Design Randomised controlled trial (FEASIBILITY STUDY)

  Study Participants Patients undergoing Ivor Lewis Oeosphagectomy

  Eligibility Criteria
  Inclusion Criteria:
  • All patients over the age of 18 undergoing Ivor Lewis oesophagectomy in Derriford.
  Exclusion Criteria:
  • Patient declined to participate.
  • Impassable stricture at endoscopy.
  • Patient is unable to give consent.

  Planned Sample Size 24- 32 patients

  Follow-up Duration 3 months

  Planned Study Period 1 year

  Primary Objectives
  To measure:
  • Number of patients approached
  • Number of patients who agreed to be randomised
  • Number of patients successfully randomised
  • Number of patients who drop out
  • Successful measurement of outcome measures

  Secondary Objective
  • Blinding of the research team
  • Completion of questionnaire by patients to assess the ease of randomisation and their opinion about the consent process.

• REC name

  East of England - Cambridge South Research Ethics Committee

• REC reference

  21/EE/0254

• Date of REC Opinion

  1 Dec 2021

• REC opinion

  Further Information Favourable Opinion