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Trial registered on ANZCTR


Registration number
ACTRN12611001192976
Ethics application status
Approved
Date submitted
7/11/2011
Date registered
17/11/2011
Date last updated
17/11/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Efficacy of permanent sacral nerve Stimulation upon constipation symptoms in patients with severe constipation: A Randomised Controlled trial
Scientific title
The Efficacy of permanent sacral nerve Stimulation upon constipation symptoms in patients with severe constipation.
Secondary ID [1] 273340 0
Nil
Universal Trial Number (UTN)
Trial acronym
SNS for constipation
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Slow transit constipation 279109 0
Condition category
Condition code
Oral and Gastrointestinal 279303 279303 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
Double blind crossover trail
The surgical placement of a sacral nerve stimulator is a 1 hour operation under general anaesthetic performed in day surgery. A pacemaker is surgically placed in the buttock and a lead attached to the pacemaker is positioned along side S3 or S4.
After surgical placement of the sacral nerve stimulator . The electrical stimulation is turned on. The patient is placed on either a subsensory stimulation or a sham stimulation for a 3 week period
Setting 1- 3 weeks sham v subsensory setting
Device is then turned off for a 2week wash out period
Wash Out (WO) 1 2weeks
Setting 2- 3 weeks sham v subsensory setting
WO2 2weeks
Setting 3 - 3 weeks sham v suprasensory setting
WO3 2weeks
Setting 4 - 3 weeks sham v suprasensory setting

Both supasensory and subsensory stimulation from SNS for constipation
patients then enter a 2 year followup on patient preferred setting
Intervention code [1] 283683 0
Treatment: Devices
Intervention code [2] 283695 0
Treatment: Surgery
Comparator / control treatment
This is a crossover study where the patients act as their own control

All patients receive an active device but both sham and active stimulation settings will be tested

Patients are blinded to the setting changes and informed that some may work better than others and some may be felt and others not.

Patients are placed on a 0 stimulation setting during the sham stimulation periods.
only 1 research operator is unblinded and all those reviewing results are blinded until close of the study.
Sham settings go for 3 weeks and are followed by a 2week wash out period before the next setting change
Control group
Placebo

Outcomes
Primary outcome [1] 279912 0
Feeling of complete evacuation on 2 or more days per week

Patients complete a daily record of all bowel movements on a stool diary. These diaries are filled out for each day the patients are on a randomised control setting. the diary asks the patient to rate each daily movemnt if ther is one as accompanied by 'afeeling of complete evacuation or not. patients fillout a yes or no to this question for each recorded bowel movement at all stages of the trial
Timepoint [1] 279912 0
Feeling of complete evacuation is assessed at each changover point.
Baseline
1 - 3weeks
2 - 5 weeks
3 - 8 weeks
4- 10 weeks
5 - 13weeks
6- 15 weeks
7- 18 weeks
Secondary outcome [1] 294763 0
Reduction in laxitives
Patients complete a daily record of all bowel movements on a stool diary. These diaries are filled out for each day the patients are on a randomised control setting. the diary asks the patient to record laxatives taken and the doses on a daily basis
Timepoint [1] 294763 0
Baseline
1 - 3weeks
2 - 5 weeks
3 - 8 weeks
4- 10 weeks
5 - 13weeks
6- 15 weeks
7- 18 weeks
Secondary outcome [2] 294764 0
Change to SF 36 Quality of life Questionaire
Timepoint [2] 294764 0
Baseline
1 -3 weeks
2- 8 weeks
3- 13weeks
4- 18 weeks

Eligibility
Key inclusion criteria
Patients must be
Rome II positive for constipation with unsatisfactory response to standard therapies
Slow transit constipation confirmed by scintigraphic or marker study
free of medication which indicates constipation as a side effect
Patients complete a 3week stool diary detailing bowel movements on a daily basis over a 3 week period
Eligiblty is determined on the basis of less than 2 days per week a feeling of incomplete evacuation.
Rome II positive according to survey 'A study of Constipation'
Slow transit constipation with a % retention greater than 9% @ 72 hours
Normal ano rectal manometry
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Prior abdominal surgery(ecept cholecystectomy, appendectomey, hernia repair, splenecomy, fundoplication;oophorectomy or hysterectomy)
Medications which list constipation as a side effect
Other medical complications
non english speaker or an inability to provide informed consent
inability to make fortnightly visits to St George Hospital over a 3 month period

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)
Allocation was concealed by, central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Patients randomised by an external body
all patient identification private

simple randomisation table created by computer software
age gender and hospital wher surgery completed are used for the stratification
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Doudle blind crossover randomised control trial
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not 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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284168 0
Government body
Name [1] 284168 0
National health and Medical research council
Address [1] 284168 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601
Country [1] 284168 0
Australia
Primary sponsor type
Individual
Name
Prof Ian COOK MD (SYD) FRACP
Address
St George Hospital and Medical complex
Suite 14,
5th Floor
1 south st
KOGARAH 2217
NSW
Country
Australia
Secondary sponsor category [1] 269122 0
Commercial sector/Industry
Name [1] 269122 0
medtronics
Address [1] 269122 0
Medtronic Australasia Pty Ltd
97 Waterloo Road
North Ryde NSW 2113
Country [1] 269122 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286125 0
UNSW Ethics comittee
Ethics committee address [1] 286125 0
The University of New South Wales,
Gate 9 High St
Kensington, Sydney
NSW 2052
Ethics committee country [1] 286125 0
Australia
Date submitted for ethics approval [1] 286125 0
Approval date [1] 286125 0
01/01/2008
Ethics approval number [1] 286125 0
The efficacy of permanent sacral nerve stimulation upon constipation symptoms in patients with severe constipation



University of NSW : HREC 07198
Ethics committee name [2] 286126 0
Human Research Ethics committee CRGH
Ethics committee address [2] 286126 0
Concord repatriation general hospital CRGH
Hospital Road
concord NSW 2139
Ethics committee country [2] 286126 0
Australia
Date submitted for ethics approval [2] 286126 0
Approval date [2] 286126 0
18/07/2008
Ethics approval number [2] 286126 0
HREC 08/CRGH /59
Ethics committee name [3] 286127 0
south eastern sydney Local health district human research ethics committee Southern sector (EC00135)
Ethics committee address [3] 286127 0
James Laws House
St george Hospital
Gray St
KOGARAH 2217
NSW
Ethics committee country [3] 286127 0
Australia
Date submitted for ethics approval [3] 286127 0
Approval date [3] 286127 0
01/01/2008
Ethics approval number [3] 286127 0
St George Hospital : SESIAHS (SS) 05/122

Summary
Brief summary
the trial investigates whether the symptoms of chronic constipation can be relieved using the novel therapy of sacral nerve stimulation.
A pacemaker device is surgically implanted above the sacral nerve so that an electrical stimulation can be applied to either S3 or S4. This has been shown to normalise the colonic contractions in faecal incontinence.
This study intends to test wether the same stimulation will have an effect on the symptoms of chronic constipation.
Trial website
Trial related presentations / publications
Nil till trial complete
Public notes

Contacts
Principal investigator
Name 33358 0
Address 33358 0
Country 33358 0
Phone 33358 0
Fax 33358 0
Email 33358 0
Contact person for public queries
Name 16605 0
Linda Hunt
Address 16605 0
St george Hospital
gastroenterology dept
gray St
KOGARAH NSW
2217
Country 16605 0
Australia
Phone 16605 0
612 91134152
Fax 16605 0
612 91133993
Email 16605 0
l.hunt@unsw.edu.au
Contact person for scientific queries
Name 7533 0
Linda Hunt
Address 7533 0
St george Hospital
gastroenterology dept
gray St
KOGARAH
2217
NSW
Country 7533 0
Australia
Phone 7533 0
61291134152
Fax 7533 0
61291133993
Email 7533 0
l.hunt@unsw.edu.au

No data has been provided for results reporting
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