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The Efficacy of permanent sacral nerve Stimulation upon constipation symptoms in patients with severe constipation: A Randomised Controlled trial

Not Applicable
Active, not recruiting
Conditions
Slow transit constipation
Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Registration Number
ACTRN12611001192976
Lead Sponsor
Prof Ian COOK MD (SYD) FRACP
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Active, not recruiting
Sex
All
Target Recruitment
59
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

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

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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