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Trial registered on ANZCTR


Registration number
ACTRN12615001096549
Ethics application status
Approved
Date submitted
17/09/2015
Date registered
19/10/2015
Date last updated
15/11/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Proof of principle study of transabdominal gastrointestinal stimulation (TAGS) for adult constipation.
Scientific title
Proof of principle study of the efficacy of transabdominal gastrointestinal stimulation (TAGS) for the treatment of adult constipation.
Secondary ID [1] 287492 0
NA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic constipation in adults 296236 0
Condition category
Condition code
Oral and Gastrointestinal 296507 296507 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
A four month treatment period whereby the patient applies non invasive transabdominal gastrointestinal stimulation (TAGS) for one hour per day using a convenient garment that houses the electrodes. TAGS delivers a safe electrical stimulation to the abdomen. The stimulation parameters used are in common use by physiotherapists for treating pain (4,000hz carrier with a sweep frequency between 80 -160Hz) at a current level that is comfortable for each patient.
Intervention code [1] 292875 0
Treatment: Devices
Comparator / control treatment
This is an proof of principle uncontrolled study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296134 0
Constipation symptom severity score (PAC SYM)
Timepoint [1] 296134 0
At 8 weeks and 16 weeks
Secondary outcome [1] 317587 0
* Defaecation frequency, volume, consistency recorded by the patient in the study diary
Timepoint [1] 317587 0
At 8 weeks and 16 weeks
Secondary outcome [2] 317897 0
* Frequency of straining during defecation,
recorded by the patient in the study diary
Timepoint [2] 317897 0
At 8 and 16 weeks
Secondary outcome [3] 317898 0
* Feeling of incomplete evacuation,
recorded by the patient in the study diary
Timepoint [3] 317898 0
At 8 and 16 weeks
Secondary outcome [4] 317899 0
* Abdominal pain, recorded by the patient in the study diary
Timepoint [4] 317899 0
At 8 and 16 weeks
Secondary outcome [5] 317900 0
* Bloating, recorded by the patient in the study diary
Timepoint [5] 317900 0
At 8 and 16 weeks
Secondary outcome [6] 317901 0
* Effect on daily activities, recorded by the patient in the study diary
Timepoint [6] 317901 0
At 8 and 16 weeks
Secondary outcome [7] 317902 0
* Need for manual assistance to evacuate, recorded by the patient in the study diary

Timepoint [7] 317902 0
At 8 and 16 weeks
Secondary outcome [8] 317903 0
* Laxative use, recorded by the patient in the study diary
Timepoint [8] 317903 0
At 8 and 16 weeks
Secondary outcome [9] 317904 0
Quality of life (QOL) - (PAC-QOL) recorded by the patient in the PAC QOL questionnaire form
Timepoint [9] 317904 0
At 8 and 16 weeks

Eligibility
Key inclusion criteria
* Patients aged between 18 and 75 with chronic functional idiopathic constipation as defined by a > 6 month history of:
a) Less than or equal to two “spontaneous complete bowel movement” (SCBM)/week for at least 6 months prior to recruitment
b) At least 25% of the time suffer from at least one symptoms of: lumpy/hard stools, sensation of incomplete evacuation, need to strain during defaecation
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Constipation secondary to endocrine causes, metabolic causes or neurological conditions
* Known or suspected organic disorders of the large bowel
* Serious chronic medical condition
* Surgical procedure on the large bowel or rectum
* Pregnancy or planning to become pregnant
* Insufficient comprehension of English requiring a translator
* Implanted cardiac defibrillator or pacemaker

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)
All patients that meet the inclusion criteria included. No randomisation
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
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
Qualitative assessment. No sample size calculation was performed.

Recruitment
Recruitment status
Completed
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 in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 4353 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 4354 0
John Hunter Hospital Royal Newcastle Centre - New Lambton

Funding & Sponsors
Funding source category [1] 292066 0
Commercial sector/Industry
Name [1] 292066 0
GI Therapies
Address [1] 292066 0
Level 9, 31 Queen Street, Melbourne VIC 3000
Country [1] 292066 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
GI Therapies Pty Ltd
Address
Level 9
31 Queen Street
melbourne VIC 3000
Country
Australia
Secondary sponsor category [1] 290741 0
Hospital
Name [1] 290741 0
John Hunter Hospital
Address [1] 290741 0
1 Kookaburra Circuit
New Lambton NSW 2305
Country [1] 290741 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293549 0
Hunter New England Research Ethics Committee
Ethics committee address [1] 293549 0
Locked Bag No 1
New Lambton NSW 2305
Ethics committee country [1] 293549 0
Australia
Date submitted for ethics approval [1] 293549 0
06/08/2015
Approval date [1] 293549 0
08/09/2015
Ethics approval number [1] 293549 0
15/08/19/3.03

Summary
Brief summary
A pilot study to assess the effectiveness of a medical device to treat chronic constipation in adults
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59762 0
Prof Nicholas Talley
Address 59762 0
Faculty of Health & Medicine
HMRI Building
1 Kookaburra Ct
New Lambton
NSW, 2305
Country 59762 0
Australia
Phone 59762 0
+61 2 49215885
Fax 59762 0
Email 59762 0
nicholas.talley@newcastle.edu.au
Contact person for public queries
Name 59763 0
Dr Natasha Koloski
Address 59763 0
Research Fellow & Research Manager
Faculty of Health, University of Newcastle
Department of Gastroenterology, Princess Alexandra Hospital
237 Ipswich Rd, Woolloongabba QLD 4102
Country 59763 0
Australia
Phone 59763 0
+61 407 126 897
Fax 59763 0
Email 59763 0
natasha.koloski@newcastle.edu.au
Contact person for scientific queries
Name 59764 0
Dr Bridget Southwell
Address 59764 0
Murdoch Childrens Research Institute
Royal Childrens Hospital
50 Flemington Road
Parkville VIC 3052
Country 59764 0
Australia
Phone 59764 0
+61 3 9345 5069
Fax 59764 0
Email 59764 0
bridget.southwell@mcri.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary