Bisacodyl Oral for Lowering Dysfunction (of Tenckhoff Catheter) (BOLD)

The Chinese University of Hong Kong

Status and phase

Not yet enrolling

Phase 4

Conditions

Peritoneal Dialysis

Renal Failure Chronic Requiring Dialysis

Treatments

Drug: Bisacodyl 5 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT07351357

CREC-2025-492

Details and patient eligibility

About

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.

Full 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.

Enrollment

398 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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