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Trial registered on ANZCTR


Registration number
ACTRN12619000086167p
Ethics application status
Submitted, not yet approved
Date submitted
15/12/2018
Date registered
22/01/2019
Date last updated
22/01/2019
Date data sharing statement initially provided
22/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy trial of a novel stoma device
Scientific title
Efficacy Trial of a Novel Pump Device for Output Recycling in Patients with High-Output Losses
Secondary ID [1] 296843 0
Nil Known
Universal Trial Number (UTN)
U1111-1225-6041
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 high-output stomas and fistulas 310751 0
Condition category
Condition code
Oral and Gastrointestinal 309442 309442 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 trial will evaluate the efficacy and safety of a novel nutrient recycling pump device for patients with high-output stomas and fistulas. 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 patients 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 study will be a before and after trial. Baseline data will be recorded for one week. The intervention (pump device) will then be initiated. Patients will have a tube inserted into the distal stoma limb, with a pump attached, and will be trained in the use of the device according to a standardised template and with the help of visual aids. The training will be conducted on an individual basis (face-to-face) by a member of the research team with the assistance of an standardised instruction manual and visual aids. The training session will take approximately 15 minutes.

- The intervention will be delivered over a 4 week evaluation period. The primary outcome will be cessation vs continuation of parenteral therapy (parenteral nutrition and/or replacement IV fluids). Judgement of the primary outcome will be made at the end of the 4 week period. Withdrawal of the device will also be subsequently undertaken in selected patients to validate the primary outcome.

Once the primary trial is completed, the patient will enter an optional maintenance phase, where the device will be available on request. This could continue for a period of up to 6 months in patients or time of reversal surgery (as per device availability).

Strategies to monitor adherence:
- research team monitoring / observations and later patient self-reporting.
Intervention code [1] 313125 0
Treatment: Devices
Comparator / control treatment
This study has a before/after design and does not have external controls.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308396 0
Cessation of requirement for IV fluid therapy and/or parenteral nutrition within 4 weeks of starting the intervention.
- primary outcome will be assessed by monitoring of fluid / parental therapy administration medical charts, and will be met when parental therapy charting reaches zero for 3 consecutive study days
- to be validated by the subsequent withdrawal of the intervention to test for reversal of primary outcome and/or alternative stopping point
Timepoint [1] 308396 0
Within 4 weeks of intervention (minimum of 3 weeks of therapy)
Primary outcome [2] 318539 0
Device Safety.

- Assessed by adverse events/complications recorded by Clavien-Dindo grade. These will be assessed by regular semi-structured interview with patients and medical providers and routine assessments of medical records. it will be noted whether any adverse events are related or unrelated to device use or if this is uncertain.
- Rate of significant (Grade IIIA+) events related to device use is primary outcome of interest

Adverse events will be periodically reported to our DMC to be assessed for severity and causality. Serious adverse events and suspected unexpected serious adverse events will be notified directly to the DMC within 24 hours of being registered in the report forms.

[note: minor adverse GI symptoms are anticipated during initiation of device use, similar in nature and duration to what is seen following stoma reversal surgery, which needs to be managed by an induction period (this is accounted for in the study design)]

Timepoint [2] 318539 0
Over 4 weeks of therapy
Secondary outcome [1] 354856 0
Net stoma/fistula losses (data linkage to medical records)
- for inpatients: as per clinical fluid-balance log records
- for outpatients: twice weekly patient-reported measurement

Timepoint [1] 354856 0
Before (1-week pre-intervention) vs after 4 weeks of therapy
Secondary outcome [2] 354857 0
Gastrointestinal recovery time following reversal surgery:
- As measured by time to 'GI 2' - i.e. daily monitoring of time to tolerance of oral diet and passage of bowel motions, as per the definition of ileus used by van Bree et al (Ann Surg 2014;259(4):708-14), and occurrence of prolonged post-operative ileus as per the definition proposed by Vather et al (J Gastrointestinal Surg 2013;17:962-72).
Timepoint [2] 354857 0
This data will be recorded following stoma reversal surgery until the patient is tolerating an oral diet, is passing bowel motions and does not have an ileus. As above, the criteria of van Bree et al (Ann Surg 2014;259(4):708-14) and Vather et al (J Gastrointestinal Surg 2013;17:962-72) will be applied.
Secondary outcome [3] 354859 0
Impact on ostomy management (composite outcome):
- by structured weekly assessments (study-specific questionnaire), including impact of device use on ease of appliance management, peri-stomal skin health, and occurrence of leak events.
Timepoint [3] 354859 0
Before (1-week pre-intervention) vs after 4 weeks of therapy
Secondary outcome [4] 354860 0
Quality of Life:
- using EQ5D-5L and Ostomy Adjustment Scale
Timepoint [4] 354860 0
Before (1-week pre-intervention) vs after 4 weeks of therapy
Secondary outcome [5] 354861 0
Device performance criteria (composite outcome):
- assessed by custom semi-structured interview (study-specific questionnaire) and monitoring of any device or tube failures and the mode of failure (following clinical or patient reporting of a device failure event)

Timepoint [5] 354861 0
Before (1-week pre-intervention) vs after 4 weeks of therapy
Secondary outcome [6] 354862 0
Costs of care:
- economic evaluation of relevant treatment costs before vs. after therapy, as measured by calculating difference between resource use and costs from medical records in the baseline evaluation phase (1 week prior to onset of intervention) and during last week of intervention period.
Timepoint [6] 354862 0
This outcome will be assessed at the completion of the study once all costs are able to be reviewed, at end of 4 weeks of therapy.
Secondary outcome [7] 365313 0
Renal function as measured by weekly serum assay
Timepoint [7] 365313 0
Before (1-week pre-intervention) vs after 4 weeks of therapy
Secondary outcome [8] 365314 0
Serum K+ - before (1-week pre-intervention) vs after 4 weeks of therapy
Timepoint [8] 365314 0
Before (1-week pre-intervention) vs after 4 weeks of therapy
Secondary outcome [9] 365315 0
Days spent in hospital, by assessment of inpatient clinical stay records
Timepoint [9] 365315 0
Counted at end of 4 weeks of therapy.
Secondary outcome [10] 365316 0
Use of stoma/fistula-related medications that slow bowel output (loperamide, codeine, octreotide) - by data linkage to medical records.
Timepoint [10] 365316 0
Comparison of before (1-week pre-intervention) vs after at 4 weeks of therapy.
Secondary outcome [11] 365317 0
Patient satisfaction with use of device, by structured study-specific questionnaire (Likert scales on difficulty of use)
Timepoint [11] 365317 0
Over 4 weeks of therapy, assessed at end of therapy.
Secondary outcome [12] 365940 0
Mg++
Timepoint [12] 365940 0
Serum Mg+ - before (1-week pre-intervention) vs after 4 weeks of therapy
Secondary outcome [13] 365941 0
Na+
Timepoint [13] 365941 0
Serum Na+ - before (1-week pre-intervention) vs after 4 weeks of therapy

Eligibility
Key inclusion criteria
- Patient aged 18 or older, with double enterotomy/enterocutaneous fistula
- Inability to maintain nutrition and fluid requirement without parenteral therapy (IV fluids and/or parenteral nutrition)
- Established or anticipated to develop (by specialist clinician opinion) Type II intestinal failure as defined by requirement of parenteral support for >20 days.
- Distal orifice can be intubated by a minimum 24Fr feeding tube (dilitation of stoma orifice strictures is allowable)
- If a distal anastomosis present, anastomotic leak and distal obstruction will be excluded e.g. via gastrograffin enema or CT scan with rectal contrast or clinical evaluation such as endoscopy, when clinically indicated.
- Able to independently manage their stoma, or consistent daily caregiver available who can support regular stoma management
- Able to understand risks and benefits of the study
- Able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Under 18 years of age
- Active anastomotic leak, perforation or distal obstruction
- Distal gut out of circuit for >6 months
- Inadequate total function gut length
- Underlying gastrointestinal motility disorder such as chronic intestinal pseudo-obstruction, gastroparesis or slow-transit constipation
- Scheduled for stoma closure or fistula surgery within the next 4 weeks (insufficient time to allow minimum study evaluation periods of 1 week before and 3 weeks after intervention)
- Unable to understand the risks/benefits of the study to provide informed consent
- Previous or current diagnosis of Clostridium Difficile colitis

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All patients participating in the trial will receive the intervention
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Before and after study - no external controls. Patients will have a 4 week period with the intervention, Subsequently, the intervention will be ceased and we will assess if the primary outcome is reversed
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The primary outcome of before vs after requirement for parenteral therapy will be examined by a Fisher's Exact Test.
Secondary outcomes will be evaluated for distribution and skew, and summary statistics and appropriate tests will be applied accordingly.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21117 0
New Zealand
State/province [1] 21117 0
Country [2] 21128 0
United Kingdom
State/province [2] 21128 0
London

Funding & Sponsors
Funding source category [1] 301417 0
Government body
Name [1] 301417 0
NZ MedTech CoRE - An NZ Governtment Funded Centre of Research Excellence
Address [1] 301417 0
Auckland Bioengineering Institute, The University of Auckland,
70 Symonds Street,
Auckland 1142
Country [1] 301417 0
New Zealand
Funding source category [2] 301457 0
Commercial sector/Industry
Name [2] 301457 0
Surgical Design Studio (SDS Push)
Address [2] 301457 0
7 Railway St
Newmarket
Auckland 1023
Country [2] 301457 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Auckland Bioengineering Institute, The University of Auckland,
70 Symonds Street,
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 301097 0
Commercial sector/Industry
Name [1] 301097 0
Surgical Design Studio (SDS Push Ltd)
Address [1] 301097 0
7 Railway St
Newmarket
Auckland 1023
Country [1] 301097 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 302150 0
NZ Health and Disability Ethics Committee
Ethics committee address [1] 302150 0
Ministry of Heath
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 302150 0
New Zealand
Date submitted for ethics approval [1] 302150 0
17/12/2018
Approval date [1] 302150 0
Ethics approval number [1] 302150 0

Summary
Brief summary
Aim:
To test the efficacy of a novel pump device for recycling high-output stoma and fistula losses.

Hypothesis:
- the novel device can safely and effectively return stoma and fistula outputs to the distal gut
- Output recycling will eliminate the need for parenteral support (IV fluids and/or parenteral nutrition) in patients with high-output stomas and fistulas and an accessible distal gut

Patients with high-output stomas/fistulas face substantial morbidities such as; fluid and electrolyte losses, renal impairment, prolonged hospital stays, loss of the microbiome, post-op ileus, impaired quality of life and large cost burdens on the health care industry.

A potential remedial solution to the morbidity of high-output losses is to recycle the losses back into the distal gastrointestinal tract. The concept of chyme reinfusion is well known and has been broadly validated as feasible and appropriate.

A nutrient recycling pump offering a significantly improved workflow has been designed . This device is currently in the final stages of a first-in-human feasibility study. The device is showing sustained performance in achieving successful nutrient recycling across a broad range of effluent viscosities.

The device is now ready for efficacy trials to formally evaluate whether nutrient recycling can be achieved in a sustained fashion during clinical use.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89294 0
A/Prof Gregory O'Grady
Address 89294 0
Department of Surgery
University of Auckland
Private Bag 92019
Auckland Mail Centre 1142
Country 89294 0
New Zealand
Phone 89294 0
+64 274222989
Fax 89294 0
Email 89294 0
greg.ogrady@auckland.ac.nz
Contact person for public queries
Name 89295 0
A/Prof Gregory O'Grady
Address 89295 0
Department of Surgery
University of Auckland
Private Bag 92019
Auckland Mail Centre 1142
Country 89295 0
New Zealand
Phone 89295 0
+64 274222989
Fax 89295 0
Email 89295 0
greg.ogrady@auckland.ac.nz
Contact person for scientific queries
Name 89296 0
A/Prof Gregory O'Grady
Address 89296 0
Department of Surgery
University of Auckland
Private Bag 92019
Auckland Mail Centre 1142
Country 89296 0
New Zealand
Phone 89296 0
+64 274222989
Fax 89296 0
Email 89296 0
greg.ogrady@auckland.ac.nz

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 other documents available
Summary results
No Results