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Trial registered on ANZCTR


Registration number
ACTRN12618001095257
Ethics application status
Approved
Date submitted
24/06/2018
Date registered
29/06/2018
Date last updated
21/11/2018
Date data sharing statement initially provided
21/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Novel Device for Refeeding output in Stoma and Fistula Patients
Scientific title
The Feasibility of Re-infusion of Ileostomy and Fistula Output Within a Stoma Appliance to Reduce the Incidence of Fluid and Electrolyte Imbalances.
Secondary ID [1] 295291 0
18/431
Universal Trial Number (UTN)
U1111-1201-8684
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Enterostomy 308474 0
Enterocutaneous Fistula 308475 0
Condition category
Condition code
Oral and Gastrointestinal 307452 307452 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 307465 307465 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A specially designed pump device is coupled to the distal limb of the stoma or fistula via a feeding tube. The device will be inserted by an experienced clinician in the hospital setting. Insertion of the device involves intubation of the distal limb of the stoma or fistula using a MIC feeding tube. This procedure takes approximately 10 to 30 minutes, depending on the ease of distal access. Participants would not need to stay in hospital overnight unless they are already inpatients.

Patients will be instructed on how to use the pump by a study investigator. They will then be advised to use the pump on an 'as needed basis' to empty their stoma bags, over the three week trial period. A specific frequency of use is not prescribed as we wish to understand how the participants want to use the device, i.e whether they use the device to empty their appliance or whether they empty their appliance as normal into the toilet. Participants must also complete a daily ‘device diary’ which is provided to them. The device diary includes brief questions evaluating the convenience and ease of use of the device, feedback for improvement, symptoms as well as health related and stoma related quality of life questionnaires. The diary is also designed to qualitatively asses the acceptability of the device, including how patients incorporate its use into their daily life . In addition to this a study investigator will contact participants regularly to offer advice and support on using the device as well as to track the individual participant’s experience of using the device. Telephone follow up will be carried out by study investigators familiar with the device’s use and the frequency of these calls is negotiated between the participant and investigator however would be conducted at least once weekly over the test and trial period. From the feedback investigators gather from telephone interviews the design and use of the device will be improved and evaluated continuously such that overall the trial is an iterative process.

Participants will be asked to use the device, at home or as an inpatient, to reinfuse as much of their stoma or fistula output as possible. How the pump is used however is an individual decision. The actual use of the pump and reasons for not using it will inform design and workflow improvements.

Initially participants will undergo a ‘testing phase’ during which they will become familiar with using the device and any initial difficulties, such as device blockage, are addressed. This 'testing phase' is not specified and depends on the needs and circumstances of individual patients and can require up to one month. Once participants are comfortable with using the device a three week study period is initiated. During this time participants will complete their daily ‘device diary’ and any blood test results will be recorded from patient records.
Intervention code [1] 301620 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306425 0
Electrolyte derangement. This outcome is a composite of blood biochemistry results and the need for fluid or electrolyte replacement in an inpatient setting assessed from hospital records.
Timepoint [1] 306425 0
Over three weeks of device use.
Primary outcome [2] 306427 0
Patient acceptance of device as determined through daily 'device diary' questions and semi-structured telephone interviews.
Timepoint [2] 306427 0
Over the three weeks of device use.
Primary outcome [3] 306438 0
Performance of the device. This is a composite of time to reinfuse stoma appliance content, the incidence of reinfusion failure, device wear and effects on the stoma appliance. These aspects of device performance are recorded by participants in their 'Device diary' as well as this investigators will discuss these in their telephone interviews.
Timepoint [3] 306438 0
Over the three weeks of device use.
Secondary outcome [1] 348519 0
Changes in health-related quality of life measures as evaluated by the EQ-5D-5L English version for New Zealand included in the participants 'device diary'.
Timepoint [1] 348519 0
Health-related quality of life is evaluated every day, including day 0.
Secondary outcome [2] 348521 0
Time for recovery of bowel function after re-establishment of bowel continuity. This outcome is a composite of length of stay, time to food tolerance, time to first flatus and time to first bowel motion after re-establishment of bowel continuity. These measures will be collected through patient records and telephone interview.
Timepoint [2] 348521 0
After re-establishment of bowel continuity after or at the end of the three week trial period.
Secondary outcome [3] 348522 0
Influences of re-infusion on bowel health evaluated through histological analysis of microscopic differences in mucosa proximal and distal to stoma/fistula.
Timepoint [3] 348522 0
After re-establishment of bowel continuity after or at the end of the three week trial period.
Secondary outcome [4] 348600 0
Changes in stoma-related quality of life as assessed through the Ostomy Adjustment Scale included in the participant 'Device Diary'
Timepoint [4] 348600 0
Day 0, Day 7, Day 14 and Day 21

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/04/2018
Date of last participant enrolment
Anticipated
31/01/2019
Actual
Date of last data collection
Anticipated
29/03/2019
Actual
Sample size
Target
15
Accrual to date
9
Final
Recruitment outside Australia
Country [1] 10583 0
New Zealand
State/province [1] 10583 0
North Island

Funding & Sponsors
Funding source category [1] 299884 0
Commercial sector/Industry
Name [1] 299884 0
MedTech CORE
Country [1] 299884 0
New Zealand
Primary sponsor type
Individual
Name
Asscociate Professor Gregory O' Grady
Address
Department of Surgery
University of Auckland
Private Bag 92019
Auckland Mail Centre 1142
Country
New Zealand
Secondary sponsor category [1] 299242 0
Individual
Name [1] 299242 0
Professor Ian Bisset
Address [1] 299242 0
Department of Surgery
University of Auckland
Private Bag 92019
Auckland Mail Centre 1142
Country [1] 299242 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300753 0
Health and Disability Ethics Committee
Ethics committee address [1] 300753 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 300753 0
New Zealand
Date submitted for ethics approval [1] 300753 0
08/11/2017
Approval date [1] 300753 0
01/02/2018
Ethics approval number [1] 300753 0
17/NTA/241

Summary
Brief summary
This feasibility study aims to evaluate a novel pump device for the reinfusion of fistula output in its’ efficacy to prevent high-output related fluid and electrolyte imbalance. We will evaluate the rates of fluid and electrolyte derangements through clinical records in order to understand the efficacy of the device to prevent such effects of stomata and fistulae. As well as this we aim to understand the performance of the pump and patients' acceptance and tolerance of the device. Such information will be collated through interviews with participants as well as a daily ‘device diary’ which has been designed to collect parameters such as ease of use, duration of use and suggestions for improvement. Using feedback from users and issues encountered the device will be improved to fit the needs of its' users. Other outcomes we aim to evaluate include the effect of using the pump on individual's quality of life and recovery after re-establishment of bowel continuity. Through the results of this feasibility trial, we aim to improve the design and workflow of the device and develop future clinical trials.
Trial website
Trial related presentations / publications
Public notes
High-output small bowel fistulas (or surgically created high-small bowel stomas) are an uncommon but serious cause of patient morbidity and cost. Complications may result in loss of fluid and electrolytes, requirement for IV fluid replacement, risk of renal impairment, nutritional deficit and dependency on hospital care. Patients with high-output fistulas may be placed nil-per-mouth with a parental nutritional requirement that adds risk and expense to patient management.

A known solution to these problems is to recycle the ileostomy or fistula output back down the distal limb, when possible (e.g. double enterostomy fistula). There are many potential benefits of recycling output but the practice is not commonly conducted at present due to the lack of easy, efficient, cheap and portable methods . The largest assessment of continuous reinfusion of ‘chyme’ via extracorporeal circulation, included 212 French patients with ileostomies or enterocutaneous fistulae. This study found that reinfusion at home was feasible in selected patients and reinfusion improved nutritional status, reduced intestinal output and enabled 91% of patients to stop parenteral nutrition. However, despite the good evidence for the benefits of reinfusion it has not been widely adopted into clinical practice.

This study aims to evaluate the feasibility of a new assistive pump device to prevent nutrient and fluid loss from stomata and fistulae by pumping the output from the stoma to the distal limb of the intestine.
Attachments [1] 2805 2805 0 0
/AnzctrAttachments/375411-HDEC_Letter_17NTA241_Approved_FULL_Application (1).pdf (Ethics approval)
Attachments [2] 2807 2807 0 0
/AnzctrAttachments/375411-Medical Device Detail - Printer Friendly Form.pdf (Other)

Contacts
Principal investigator
Name 84702 0
A/Prof Gregory O' Grady
Address 84702 0
Department of Surgery
University of Auckland
ACH Support Building
Level 12, Room 12.085
Park Road, Grafton
Country 84702 0
New Zealand
Phone 84702 0
+64 09 373 7599 ext 89821
Fax 84702 0
+64 09 377 9656
Email 84702 0
[email protected]
Contact person for public queries
Name 84703 0
Puja Sharma
Address 84703 0
Department of Surgery
University of Auckland
ACH Support Building
Level 12, Room 12.085
Park Road, Grafton
Country 84703 0
New Zealand
Phone 84703 0
+64 027 882 4720
Fax 84703 0
Email 84703 0
[email protected]
Contact person for scientific queries
Name 84704 0
Gregory O' Grady
Address 84704 0
Department of Surgery
University of Auckland
ACH Support Building
Level 12, Room 12.085
Park Road, Grafton
Country 84704 0
New Zealand
Phone 84704 0
+64 09 373 7599 ext 89821
Fax 84704 0
+64 09 377 9656
Email 84704 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
This is a feasibility trial of a novel device, as the trial is currently ongoing and final data has not been assessed, as a result, the value/ option of making IPD available has not been evaluated and discussed by all study investigators. This step will be taken once recruitment has closed and all participants have exited the study.


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.