Proof of principle study of transabdominal gastrointestinal stimulation (TAGS) for adult constipation.
- Conditions
- Chronic constipation in adultsOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
- Registration Number
- ACTRN12615001096549
- Lead Sponsor
- GI Therapies Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 20
* 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
* 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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Constipation symptom severity score (PAC SYM) [At 8 weeks and 16 weeks]
- Secondary Outcome Measures
Name Time Method * Defaecation frequency, volume, consistency recorded by the patient in the study diary<br>[At 8 weeks and 16 weeks];* Frequency of straining during defecation, <br>recorded by the patient in the study diary<br>[At 8 and 16 weeks];* Feeling of incomplete evacuation, <br>recorded by the patient in the study diary<br>[At 8 and 16 weeks];* Abdominal pain, recorded by the patient in the study diary<br>[At 8 and 16 weeks];* Bloating, recorded by the patient in the study diary<br>[At 8 and 16 weeks];* Effect on daily activities, recorded by the patient in the study diary<br>[At 8 and 16 weeks];* Need for manual assistance to evacuate, recorded by the patient in the study diary<br><br>[At 8 and 16 weeks];* Laxative use, recorded by the patient in the study diary<br>[At 8 and 16 weeks];Quality of life (QOL) - (PAC-QOL) recorded by the patient in the PAC QOL questionnaire form[At 8 and 16 weeks]