Effectiveness of Rectal Balloon Training in Obstructive Defaecation: A Randomised Controlled Trial
Not Applicable
- Conditions
- Obstructive defecationOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12610000951055
- Lead Sponsor
- A/Prof Christopher Young
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
1) prior assessment by a doctor, nurse specialist or physiotherapist;
2) fulfill the ROME criteria of obstructive defecation
Exclusion Criteria
1) structural causes such as colorectal malignancy, full thickness rectal prolapse or a non-emptying rectocoele;
2) previous treatment with biofeedback;
3) poor command of English;
4) an underlying organic brain lesion that may limit a patient’s ability to understand or follow instructions for biofeedback;
5) unable to consent for other reasons.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in QOL for obstructive defecation patients as determined using CR QOL (constipation related quality of life) and DQOT (Direct questioning of objectives).[Baseline data will be collected prior to patients receiving the treatment. <br>The treatment involves 4 sessions with 1month interval between each sessions. Questionnaire will be administered to patients at each session. <br>Patients will be followed up 3,6 and 12 months post completion of treatment.]
- Secondary Outcome Measures
Name Time Method Improved psychological sate as determined using DASS (depression, anxiety and stress scale).[Baseline data will be collected prior to patients receiving the treatment. <br>The treatment involves 4 sessions with 1month interval between each sessions. Questionnaire will be administered to patients at each session. <br>Patients will be followed up 3,6 and 12 months post completion of treatment.];Improved symptoms as determined using CSI (constipation severity instrument)[Baseline data will be collected prior to patients receiving the treatment. <br>The treatment involves 4 sessions with 1month interval between each sessions. Questionnaire will be administered to patients at each session. <br>Patients will be followed up 3,6 and 12 months post completion of treatment.]