Bisacodyl Oral for Lowering Dysfunction (of Tenckhoff Catheter)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bisacodyl 5 mg.
- Who it may be relevant to
- Registry conditions: Renal Failure Chronic Requiring Dialysis, Peritoneal Dialysis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Multi-Centre Pragmatic Randomized Controlled Trial of Bowel Preparation Before Peritoneal Dialysis Catheter Insertion
Overview
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.
Detailed description
This study compares the result of laxative bowel preparation versus usual care before the insertion of Tenckhoff catheters for peritoneal dialysis patients. The investigators design an open-label multi-centre randomized controlled study to evaluate the prophylactic use of laxative to reduce incidence of catheter flow dysfunction after peritoneal dialysis catheter insertion. The primary objective is to assess whether laxative prophylaxis can reduce the risk of catheter dysfunction that requires intervention. The investigators estimate that the study would need to enroll 199 peritoneal dialysis patients in each group for the study to have 80% power to detect a difference between 10% and 20% in the primary endpoint of catheter dysfunction requiring simple intervention.
Interventions
- Drug Bisacodyl 5 mg
In 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.
Primary outcome measures
- Catheter dysfunction [Time frame: within 4 weeks of catheter insertion]
Secondary outcome measures (3)
- Catheter dysfunction and survival [Time frame: 3 months after catheter insertion for early peritonitis]
- The incidence of early peritonitis (within 3 months of catheter insertion) [Time frame: 3 months after catheter insertion]
- The peritoneal catheter survival [Time frame: 3 months after catheter insertion]
Eligibility criteria
Inclusion criteria
- aged 18 or older and need of peritoneal dialysis
- willingness to give written consent and comply with the study protocol
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Hong Kong · 6 centers
- Princess Margaret Hospital — Kwai Chung
- Caritas Medical Centre — Sham Shui Po
- Prince of Wales Hospital — Shatin
- Tseung Kwan O Hospital — Tseung Kwan O
- Queen Elizabeth Hospital — Yau Ma Tei
- Prince of Wales Hospital — Shatin
Identifiers
NCT: NCT07351357 · CREC-2025-492