A Novel Device for Refeeding output in Stoma and Fistula Patients
Not Applicable
Recruiting
- Conditions
- EnterostomyEnterocutaneous FistulaOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colonSurgery - Other surgery
- Registration Number
- ACTRN12618001095257
- Lead Sponsor
- Asscociate Professor Gregory O' Grady
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 15
Inclusion Criteria
Adults (>18 years of age).
Have a defunctioning loop ileostomy or enterocutaneous fistula
Able to understand risks and benefits of participating in the study.
Anastomotic leak and distal obstruction excluded on gastrograffin study or CT with contrast.
Exclusion Criteria
Immunocompromise
Pregnancy
Previous or current Clostridium difficile colitis
Distal obstruction
Anastomotic leak or perforation
Inability to understand risks/benefits and to give informed consent
Inability to independently manage a stoma bag
Lack of distal access channel (distal limb/fistula) for device insertion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method