Enhancing automated chyme reinfusion therapy with The Insides System

Not Applicable

Recruiting

• Conditions: Ostomy; Small bowel stoma; enteroatmospheric fistula; Diet and Nutrition - Other diet and nutrition disorders; Surgery - Other surgery; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12624000427572
• Lead Sponsor: The Insides Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-08
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

•Adults >=18 years of age, with defunctioning loop/double barrel/abcarian small bowel stoma or enterocutaneous fistula
•If colonic anastomosis present, anastomotic leak and distal obstruction will be excluded e.g. via gastrografin enema or CT scan with rectal contrast or clinical evaluation such as endoscopy
•If ECF patient, gastrografin enema or CT scan with rectal contrast or clinical evaluation such as endoscopy to ensure patent distal intestine
•Distal limb of stoma can be intubated with a minimum of 22 Fr feeding tube (dilatation of stoma orifice strictures is allowable)
•Able to independently manage their stoma
•Proximal and distal outlets contained within one ostomy appliance
•Able to understand the risks/benefits of the study
•Able to give informed consent

Exclusion Criteria

•<18 years of age
•Anastomotic leak or perforation
•Insufficient distal access or distal obstruction
•Current pregnancy
•Separated proximal and distal stomas that are pouched with separate ostomy appliances
•Unable understand the risks/benefits of the study and to give informed consent
•Unable to independently manage a stoma
•Inability to intubate the distal stoma
•Previous or current Clostridium difficile colitis

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of a new version of The Insides System [Face to face contact to collect verbal and written (study questionnaire) patient and nurse feedback of their experience when using the device. The study questionnaire has been developed specifically for this study. Daily for 2 weeks from the start of the intervention. ];Efficacy of a new version of The Insides System[Face to face contact to collect verbal and written (study questionnaire) patient and nurse feedback of their experience when using the device. The study questionnaire has been developed specifically for this study. Daily for 2 weeks from the start of the intervention. ]

Secondary Outcome Measures

Name	Time	Method
Patient usability of the device[Face to face contact to collect verbal and written (study questionnaire) patient and nurse feedback of their experience when using the device. The study questionnaire has been developed specifically for this study. Daily for 2 weeks from the start of the intervention. ];Identify barriers to use of the device[Face to face contact to collect verbal and written (study questionnaire) patient and nurse feedback of their experience when using the device. The study questionnaire has been developed specifically for this study. Daily for 2 weeks from the start of the intervention. ]