Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001137583
Ethics application status
Approved
Date submitted
6/10/2015
Date registered
27/10/2015
Date last updated
10/06/2021
Date data sharing statement initially provided
11/12/2018
Date results information initially provided
10/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
In vivo characterisation of pressure wave propagation in the rectosigmoid region as a target for neuromodulation for faecal incontinence
Scientific title
The use of High Resolution Colonic Manometry (HRCM) to evaluate colonic motility in patients with faecal incontinence undergoing sacral neuromodulation.
Secondary ID [1] 287620 0
None
Universal Trial Number (UTN)
U1111-1174-6911
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
faecal incontinence
 296427 0
Condition category
Condition code
Oral and Gastrointestinal 296691 296691 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
Participants are patients with faecal incontinence who has undergone extensive assessment through our pelvic floor clinic and has been placed on the scheduled for sacral neuromodulation. Sacral neuomodulation is the standard care for these patients. Sacral neuromodulation is routinely performed as a two-stage procedure by our colorectal surgeons. We plan to obtain our recordings during the stage I procedure (testing phase). This is typically performed under sedation but sometimes under general anaesthesia if clinically indicated.
Patients are instructed to fast from midnight. Patients will undergo the standard sacral neuromodulation stage I lead placement in the morning, between 0800 and 1200 depending on operating theatre availability. This takes approximately 60-90 minutes. The high-resolution colon manometry catheter will be inserted using a flexible sigmoidoscope after the completion of sacral neuromodulation placement under the same anaesthesia. The HRCM placement typically takes round 20 minutes.
Patients will be admitted overnight per usual protocol for sacral neuromodulation stage I lead placement. Manometry recordings will commence in the afternoon on the day of surgery (day 1). Patients will have to be fully alert and free from the effect of any sedative given prior to the commencement of recording.
Starting at 1400, we will first perform a two-hour high-resolution colon manometry recording with no stimulation. This will be our ‘Basal Recording.’ The implanted sacral neuromodulation lead will be connected after this period of time and a further two-hour of recording starting at 1600 will be taken using the therapeutic setting, as determined by our sacral neuromodulation nurse specialist. In the normal clinical setting, this would be the setting that patients are likely to be discharged on. After the end of this two-hour recording, patients are given a standard 700kcal meal at 1800. A further two hours of recording will be performed during the time of this meal and continue post-meal. At the end of the third two-hour recording, the high-resolution colon manometry catheter will be disconnected and the sacral neuromodulator will be turned off. Patients are left undisturbed from the study investigator for the remainder of the night. Patients are instructed to not have any oral intake after midnight, except for their regular medications and water.
On the following morning (day 2), patients will be woken at 0600 during nursing rounds. High-resolution colon manometry recording will commence again one hour after patients waking at 0700. The stimulator setting will be turned down to 50% of the amplitude from the previous day. Two hours of recording will be performed. At the end of the two hours, patients are given a 700kcal meal for breakfast at 0900. A further two-hour recording, will be carried out during the meal and continue after the meal.
At the end of the recording, the high-resolution colon manometry catheter will be removed by applying gentle traction. Our clinical nurse specialist will set sacral neuromodulator at the therapeutic setting.The clinical team will assess patients before discharge. Post-discharge care will follow on our standard sacral neuromodulation protocol.
Intervention code [1] 293011 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296295 0
colon motility patterns as measured by the High Resolution Colon Manometry.
Timepoint [1] 296295 0
Continuous manometry recording from 1400 to 2000 on day 1 (day of surgery) and from 0700 to 1100 on day 2 will be taken.
Secondary outcome [1] 318104 0
Functional result after sacral neuromodulation. This is assessed using the Fecal Incontinence Severity Index.
Timepoint [1] 318104 0
at two weeks and one year after sacral nerve stimulator placement

Eligibility
Key inclusion criteria
1. Age > 18 years.
2. Patients with faecal incontinence who are clinically indicated for sacral neuromodulator placement after being reviewed by pelvic floor specialist surgeons at Auckland City Hospital.
3. Able to understand risks and benefits of the study.
4. Able to give informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnancy.
2. Previously undergone distal colon or rectal resection.
3. Presence of slow transit constipation.
4. Metabolic, neurogenic or endocrine disorders known to cause colonic dysmotility (e.g. multiple sclerosis, Parkinson’s disease, untreated hypothyroidism).
5. Previous lumbo-­-sacral injury, surgery, or malformation.

Study design
Purpose of the study
Diagnosis
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/11/2015
Actual
19/11/2015
Date of last participant enrolment
Anticipated
Actual
6/09/2018
Date of last data collection
Anticipated
Actual
6/09/2018
Sample size
Target
30
Accrual to date
Final
18
Recruitment outside Australia
Country [1] 7209 0
New Zealand
State/province [1] 7209 0

Funding & Sponsors
Funding source category [1] 292179 0
University
Name [1] 292179 0
Department of Surgery, University of Auckland
Country [1] 292179 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
The University of Auckland
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 290853 0
None
Name [1] 290853 0
None
Address [1] 290853 0
None
Country [1] 290853 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293653 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 293653 0
Ministry of Health
Ethics Department
Freyberg Building
Reception – Ground Floor
20 Aitken Street
Wellington 6011
Ethics committee country [1] 293653 0
New Zealand
Date submitted for ethics approval [1] 293653 0
22/10/2015
Approval date [1] 293653 0
18/11/2015
Ethics approval number [1] 293653 0
15/NTA/175

Summary
Brief summary
Faecal incontinence is estimated to affect 13.2% of the New Zealand population. It is associated with psychosocial distress and social isolation. Sacral nerve stimulation has become a popular surgical treatment for people suffering from faecal incontinence that is not controlled by lifestyle modification or medications. Despite having promising results, we still do not fully understand how sacral nerve stimulation works.
One new theory is that sacral nerve stimulation helps to regulate colon motility. High-resolution colon manometry is a tool that allows us to examine colon movements through very detailed pressure recordings. Through the use of high-resolution colon manometry, we found that there is a repeated retrograde (towards the mouth) movement in the last part of the colon. We think that this may serve as a brake, to slow down contents from reaching the rectum.
In this study, we aim to use high-resolution colon manometry to map the distal colonic movements in patients with faecal incontinence undergoing sacral nerve stimulation. We also want to examine the effect of different levels of sacral nerve stimulation on this part of the colon. The results will be help us to optimised treatment protocol for patients with faecal incontinence.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60846 0
A/Prof Ian Bissett
Address 60846 0
Department of Surgery
University of Auckland
ACH Support Building
Level 12, Room 12.085
Park Road, Grafton
Auckland 1023
Country 60846 0
New Zealand
Phone 60846 0
+64 9 373 7599
Fax 60846 0
Email 60846 0
i.bissett@auckland.ac.nz
Contact person for public queries
Name 60847 0
Dr Anthony Lin
Address 60847 0
Department of Surgery
University of Auckland
ACH Support Building
Level 12, Room 12.085
Park Road, Grafton
Auckland 1023
Country 60847 0
New Zealand
Phone 60847 0
+64 9 373 7599
Fax 60847 0
Email 60847 0
anthony.lin@auckland.ac.nz
Contact person for scientific queries
Name 60848 0
Dr Anthony Lin
Address 60848 0
Department of Surgery
University of Auckland
ACH Support Building
Level 12, Room 12.085
Park Road, Grafton
Auckland 1023
Country 60848 0
New Zealand
Phone 60848 0
+64 9 373 7599
Fax 60848 0
Email 60848 0
anthony.lin@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
patient confidentiality


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
SourceTitleYear of PublicationDOI
EmbaseFaecal incontinence is associated with an impaired rectosigmoid brake and improved by sacral neuromodulation.2022https://dx.doi.org/10.1111/codi.16249
N.B. These documents automatically identified may not have been verified by the study sponsor.