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Trial registered on ANZCTR


Registration number
ACTRN12619000745145p
Ethics application status
Submitted, not yet approved
Date submitted
13/05/2019
Date registered
20/05/2019
Date last updated
20/05/2019
Date data sharing statement initially provided
20/05/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy trial of a novel stoma-output recycling device
Scientific title
A randomized controlled trial of a novel stoma-output recycling device to reduce the length of post-operative stay in patients undergoing reversal of loop ileostomy
Secondary ID [1] 297950 0
None
Universal Trial Number (UTN)
U1111-1231-5640
Trial acronym
Linked study record
ACTRN12618001964202 - Feasibility study of a novel device for recycling effluent from stomas and fistulas

Health condition
Health condition(s) or problem(s) studied:
Patients with defunctioning loop ileostomy 312348 0
Condition category
Condition code
Oral and Gastrointestinal 310910 310910 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This randomized controlled trial will investigate the efficacy and safety a novel stoma output recycling pump for patients undergoing elective reversal of their loop ileostomy.

The device is a centrifugal pump (impeller) housed within a stoma appliance and connected to an enteral feeding tube placed inside the distal limb. The pump is activated on-demand (as individually indicated by a specific patient's daily output volume) to achieve bolus refeeding, using a battery-powered driver with 5 speed settings. The correct speed setting is determined by the viscosity of the patient's chyme.

The device will be used in patients who are at least 2 weeks post-loop ileostomy formation, have confirmation of adequate downstream anastomosis healing via radiological investigation, and are at least 2 weeks away from having their ileostomy reversed.

Patients are fitted with this device in the outpatient clinic by a study investigator (who will be either a surgical registrar/consultant or stoma nurse) after enrolment, are carefully educated on how to use it, undergo a trial run with plain water in the stoma bag, and then are sent home with an information sheet and contact details of the study team if any issues arise.

The device will be used during the waiting period for ileostomy reversal (weeks to months) with the frequency of use determined by the individual patient's stoma output per day.

The per-protocol population will include all those allocated to using the device and have used it continuously daily for a minimum period of 2 weeks directly prior to the surgery date. The intention to treat population will include all those allocated to using the device and have used it at least once.

Strategies to encourage adherence:
The research team will be in regular contact with the patient to assess and encourage device usage. Patients will also self-report device use in standardised logbook diaries.
Intervention code [1] 314173 0
Treatment: Devices
Comparator / control treatment
The control group will be patients who are at least 2 weeks post-loop ileostomy formation, have confirmation of adequate downstream anastomosis healing via radiological investigation, and are at least 2 weeks away from having their ileostomy reversed but do not receive the stoma-output recycling device and continue standard care prior to reversal surgery.
Control group
Active

Outcomes
Primary outcome [1] 319732 0
Length 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
Timepoint [1] 319732 0
Date of discharge
Secondary outcome [1] 369323 0
Incidence and grade of chemotherapy-induced diarrhoea as assessed by inspecting oncology outpatient clinic letters and/or inpatient admission notes
Timepoint [1] 369323 0
From time of enrolment to completion of chemotherapy (if applicable)
Secondary outcome [2] 369324 0
The incidence of dose reduction or modification of chemotherapy regimens as assessed by inspecting oncology clinic letters and/or inpatient admission notes
Timepoint [2] 369324 0
From time of enrolment to completion of chemotherapy (if applicable)
Secondary outcome [3] 369325 0
Use of medications to slow down stoma-output as assessed by asking the patient if they needed to restart any of their previous stoma-output reducing medications. Data will be collected from the daily logbook.
Timepoint [3] 369325 0
From time of enrolment until ileostomy reversal
Secondary outcome [4] 369326 0
Net stoma losses per day (mls) as calculated by multiplying the average number of times the patient reports emptying their stoma bag per day by the average volume of each stoma bag emptying. Data will be collected from patient's daily logbook.
Timepoint [4] 369326 0
From day of enrolment until ileostomy reversal
Secondary outcome [5] 369327 0
Number of stoma bags used as assessed by the patient keeping a tally of the total number of stoma bag changes during the pre-operative period. This data will be collected from the patient's logbook.
Timepoint [5] 369327 0
From day of enrolment until ileostomy reversal
Secondary outcome [6] 369328 0
Change in renal function (eGFR)
Timepoint [6] 369328 0
eGFR blood test measured at discharge after ileostomy formation and measured in pre-admission prior to ileostomy reversal
Secondary outcome [7] 369329 0
Incidence of hospital re-admissions for stoma-related issues, such as dehydration as assessed by both inspection of electronic clinical records and from patient reporting to the study investigator
Timepoint [7] 369329 0
From day of enrolment until ileostomy reversal
Secondary outcome [8] 369330 0
Incidence of outpatient or GP visits for stoma-related complications, e.g. dehydration as assessed by self-reporting from the patient recorded in their daily logbook.
Timepoint [8] 369330 0
From day of enrolment until ileostomy reversal
Secondary outcome [9] 369331 0
Pre-operative quality of life as measured by the EQ-5D-5L and Ostomy Adjustment Scale questionnaires
Timepoint [9] 369331 0
At enrolment and repeated within 1 week prior to ileostomy reversal
Secondary outcome [10] 369332 0
Frequency of device usage per day as assessed by the daily logbook questionnaires completed by the patient. The questionnaire has been specifically designed for this study.
Timepoint [10] 369332 0
From day of enrolment until ileostomy reversal
Secondary outcome [11] 369333 0
Complications/difficulties or issues related to device usage, e.g. pump failure, catheter tube dislodgement as assessed by patient reporting the issue to the study investigator. Data is also collected from the patient's logbook.
Timepoint [11] 369333 0
From day of enrolment until ileostomy reversal
Secondary outcome [12] 369334 0
Incidence of device cessation due to intolerance or other reasons as assessed by patient reporting to the study investigator. Data will also be collected from the patient's logbook.
Timepoint [12] 369334 0
From day of enrolment until ileostomy reversal
Secondary outcome [13] 369335 0
Recovery of bowel function post-surgery as measured by time to GI2, i.e. time to tolerance of oral diet and passage of stool. (hours). This will be assessed via a brief clinical review in the morning by a study investigator and a brief questionnaire completed by the patient in the evening. The questionnaire has been specifically designed for this study.
Timepoint [13] 369335 0
From day 1 post-ileostomy reversal until endpoint met
Secondary outcome [14] 369336 0
Incidence of adverse events/complications following ileostomy reversal, e.g. bleeding, infections, anastomosis leak (classified by Clavien-Dindo grading system) as assessed by review of clinical records and patient reporting.
Timepoint [14] 369336 0
From ileostomy reversal until 30 days post-surgery
Secondary outcome [15] 369337 0
Comprehensive Complications Index (CCI) - a validated instrument measuring the sum of all complications weighted by severity as classified by Clavien-Dindo grading system
Timepoint [15] 369337 0
At time of discharge and repeated at 30 days post-surgery
Secondary outcome [16] 369338 0
Costs of inpatient care as assessed by the local district health board data analyst information regarding the individual patient's hospital stay
Timepoint [16] 369338 0
From day of enrolment until 30 days post-surgery
Secondary outcome [17] 369339 0
Low Anterior Resection Syndrome (LARS) Symptom scores
Timepoint [17] 369339 0
Measured at 30 days, 3 months, 6 months, 1 year and 3 years post-surgery
Secondary outcome [18] 369340 0
Manometry motility characteristics of the distal limb as measured by a high-resolution manometry catheter (in fasting and fed states) (from a subset of 12 patients, 6 in each arm)
Timepoint [18] 369340 0
Prior to ileostomy reversal after a minimum of 2 weeks of stoma-output recycling
Secondary outcome [19] 369341 0
Histology characteristics of the mucosal biopsies from the distal ileal limb and rectum/neorectum (from a subset of 16 patients, 8 in each arm)
Timepoint [19] 369341 0
Day of ileostomy reversal
Secondary outcome [20] 370446 0
Duration of each device usage as assessed by the logbook questionnaire completed by the patient. The questionnaire has been specifically designed for this study.
Timepoint [20] 370446 0
From enrolment to day of ileostomy reversal
Secondary outcome [21] 370447 0
Qualitative performance of device usage as assessed by the logbook questionnaire completed by the patient and via a survey performed at the end of the recycling period. The questionnaire has been specifically designed for this study.
Timepoint [21] 370447 0
From enrolment to day of ileostomy reversal

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer algorithm
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization using computer generated sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Analysis of the primary outcome will be to compare the time from admission to discharge measured in days between patients who have used the stoma-output recycling device and those that did not. Statistical significance will be determined using unpaired t test as we believe the data will be parametric. This analysis will be performed on the intention-to-treat population primarily with a subset analysis on the per-protocol group.

Secondary categorical outcomes will be analysed using the Chi-squared test or Fischer’s exact test where appropriate. Secondary continuous variables will be analysed using unpaired t test (reporting mean and standard deviation) and Mann Whitney U test (reporting median and interquartile range) for parametric and non-parametric data, respectively. Statistical testing of secondary outcomes may not be valid as specific power calculations have not been performed for each individual secondary outcome.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2019
Actual
Date of last participant enrolment
Anticipated
1/01/2021
Actual
Date of last data collection
Anticipated
1/06/2024
Actual
Sample size
Target
68
Accrual to date
Final
Recruitment outside Australia
Country [1] 21400 0
New Zealand
State/province [1] 21400 0
Auckland

Funding & Sponsors
Funding source category [1] 302471 0
Government body
Name [1] 302471 0
NZ MedTech CoRE - An NZ Government Funded Centre of Research Excellence
Country [1] 302471 0
New Zealand
Funding source category [2] 302489 0
Commercial sector/Industry
Name [2] 302489 0
Surgical Design Studio (SDS Push Ltd)
Country [2] 302489 0
New Zealand
Funding source category [3] 302490 0
Charities/Societies/Foundations
Name [3] 302490 0
New Zealand Cancer Society
Country [3] 302490 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
85 Park Road,
Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 302369 0
Commercial sector/Industry
Name [1] 302369 0
Surgical Design Studio (SDS Push Ltd)
Address [1] 302369 0
7 Railway Street,
Newmarket
Auckland 1023
Country [1] 302369 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 303133 0
NZ Health and Disability Ethics Committee
Ethics committee address [1] 303133 0
Ethics committee country [1] 303133 0
New Zealand
Date submitted for ethics approval [1] 303133 0
08/05/2019
Approval date [1] 303133 0
Ethics approval number [1] 303133 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92586 0
Dr Chen Liu
Address 92586 0
Department of Surgery
University of Auckland
Private Bag 92019
Auckland Mail Centre 1142
Country 92586 0
New Zealand
Phone 92586 0
+64 2102315048
Fax 92586 0
Email 92586 0
chenliu818@gmail.com
Contact person for public queries
Name 92587 0
Chen Liu
Address 92587 0
Department of Surgery
University of Auckland
Private Bag 92019
Auckland Mail Centre 1142
Country 92587 0
New Zealand
Phone 92587 0
+642102315048
Fax 92587 0
Email 92587 0
chenliu818@gmail.com
Contact person for scientific queries
Name 92588 0
Chen Liu
Address 92588 0
Department of Surgery
University of Auckland
Private Bag 92019
Auckland Mail Centre 1142
Country 92588 0
New Zealand
Phone 92588 0
+642102315048
Fax 92588 0
Email 92588 0
chenliu818@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Trial is assessing efficacy and safety of the novel device. Potential for possible commercialisation of this device in future limits release of individual patient data at this time.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.