Examining the effect of Creon(trademark) on patients who have had an oesphagectomy or gastrectomy.
Phase 4
Recruiting
- Conditions
- Pancreatic exocrine insufficiency (PEI)Diet and Nutrition - Other diet and nutrition disordersSurgery - Other surgeryOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12613000269730
- Lead Sponsor
- Box Hill Hospital Department of Surgery
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
Inclusion Criteria
post major upper gastrointestinal surgery at least 3months, are more than 6 weeks post chemoradiotherapy and are clinically stable. Can provide informed consent to complete the study . It is an expectation that patients included will be able to attend one initial and two follow-up appointments.
Exclusion Criteria
Participants who:
- cannot cease alcohol consumption
- whom informed consent cannot be obtained
-those patients with chronic pancreatitis, celiac disease, Chron’s disease and Zollinger-Ellison syndrome
-Any patient who is known to be hypersensitive to porcine protein must also be excluded, as this constitutes the primary active ingredient of the trial medication
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Weight: Body mass assessed using the same calibrated digital scales in the Box Hill Hospital Outpatient department.[After 4 week and 9 week assessment];Bowel function[Participants record daily bowel activity (Bristol stool chart) from baseline until the end of week 9.];Quality of life Questionnaire: FACIT-D[After 4 week and 9 week assessment]
- Secondary Outcome Measures
Name Time Method Faecal elastase: Faecal assay[After 4 week and 9 week assessment]