Bisacodyl Oral for Lowering Dysfunction (of Tenckhoff Catheter)
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorChinese University of Hong Kong
About this trial
Doctors need to insert catheter for patients who are going to have peritoneal dialysis. These peritoneal catheters can be obstructed or blocked afterward. The chance of not having smooth flow can be up to 12 and 31%. So far, constipation is one of the proposed reasons. Therefore, the study is aimed to investigate whether the preventive use of laxative before the surgery can help better improve the function of the catheter and hence better flow.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
aged 18 or older and need of peritoneal dialysis
willingness to give written consent and comply with the study protocol
Disqualifiers
known contraindication to peritoneal dialysis
ongoing diarrhoea or active inflammatory bowel disease
participation in another interventional study within last 30 days of randomization
history of a psychological illness or condition that would interfere with the patient's ability to understand the requirement of the study and/or comply with the dialysis procedures
Trial design
Design model
Parallel
Treatments tested in this trial
Bisacodyl 5 mg
DrugIn the intervention arm, the protocol of prophylactic laxative is administration of oral enteric coated bisacodyl 5 mg at bedtime for two consecutive days prior to Tenckhoff catheter insertion. In the control arm, patients will receive usual care, and are allowed to continue their usual laxative, without extra prescription.
Treatment groups
398 Participants
are divided into 2 treatment groupsGroup A: Bowel preparationActive comparator 1 intervention
Group B: Usual careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Catheter dysfunction
Primary outcome is the incidence of catheter dysfunction that requires simple and invasive manipulation by fluoroscopic or surgical procedure. Catheter dysfunction refers to drainage failure, as defined by the inability to drain peritoneal dialysate effluent reliably within 45 minutes. Simple intervention includes use of irrigation of catheter with saline, fibrinolytic agent such as urokinase and extra laxative use. Invasive manipulation of catheter includes repositioning or reinsertion, either by fluoroscopic method, open surgical or laparoscopic method.
Time frame
within 4 weeks of catheter insertionSecondary outcomes
1
Catheter dysfunction and survival
The time to catheter dysfunction requiring invasive intervention
Time frame
3 months after catheter insertion for early peritonitis2
The incidence of early peritonitis (within 3 months of catheter insertion)
Peritonitis
Time frame
3 months after catheter insertion3
The peritoneal catheter survival
catheter survival
Time frame
3 months after catheter insertionSponsors and contacts
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Source ClinicalTrials.gov
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