Efficacy trial of a novel stoma-output recycling device

Not Applicable

• Conditions: Patients with defunctioning loop ileostomy; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12619000745145
• Lead Sponsor: niversity of Auckland

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-20
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

•Defunctioning loop ileostomy created during colorectal/gynaecological resection surgery at least 2 weeks prior to enrolment into the study in the Auckland District Health Board catchment area
•Age > or = 18 years
•Anastomotic leak excluded (via gastrograffin study/ CT with rectal contrast/ endoscopy)
•Distal limb of ileostomy can be intubated by a minimum 24Fr feeding tube (dilatation of stoma orifice strictures is allowable)
•Able to demonstrate they are able to independently manage their stoma or have a consistent daily caregiver available who can support regular stoma management
•Able to understand risks and benefits of participating in the study
•Able to provide informed consent

Exclusion Criteria

•Pregnancy
•Non-English-speaking patients
•Insufficient distal access channel (distal limb/fistula) for device insertion
•Distal obstruction or anastomotic leak or perforation
•Scheduled for stoma reversal within 2 weeks of enrolment date (insufficient time to allow for minimum intervention period of 2 weeks)
•Patient and/or clinical team do not wish to have the loop ileostomy reversed
•Previous or current Clostridium difficile colitis
•Pre-existing gastrointestinal motility disorders including slow transit constipation, outlet obstruction, faecal incontinence and gastroparesis
•Inflammatory bowel disease
•Metabolic, neurogenic or endocrine disorders known to cause colonic dysmotility, e.g. multiple sclerosis, Parkinson’s disease, hypothyroidism
•Planned laparotomy for ileostomy reversal
•Formation of ileal pouches (colonic pouches acceptable)
•Known peritoneal metastatic disease prior to ileostomy closure (acceptable if only discovered at time of ileostomy closure)
•Liver cirrhosis
•Hereditary coagulopathy, e.g. von Willebrand disease
•Severe chronic renal impairment prior to ileostomy formation (eGFR<30mL/min/1.73m2)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ength of hospital stay (days) after reversal of loop ileostomy as measured by simple calculation of the number of full days spent in hospital between date of discharge and date of admission collected from patient's medical records[Date of discharge ]