Multi-Centre Pragmatic Randomized Controlled Trial of Bowel Preparation Before Peritoneal Dialysis Catheter Insertion
| Registry | NCT07351357, acronym BOLD |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: none, prevention |
| Enrollment | 398 (Estimated) |
| Sponsor | Chinese University of Hong Kong (Other) |
| Conditions | Renal Failure Chronic Requiring Dialysis, Peritoneal Dialysis |
| Interventions | Bisacodyl 5 mg (Drug) |
| Dates | start 2026-01-12, primary completion 2027-08-30 (estimated), completion 2027-09-30 (estimated), first posted 2026-01-20, last updated 2026-10-21 |
| Locations | 6 sites in Hong Kong |
Related Papers Related Patents Related Grants Related Experts
All trials for Renal Failure Chronic Requiring Dialysis All trials for Peritoneal Dialysis All trials of Bisacodyl 5 mg
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Bowel preparation | Active comparator | Drug: Bisacodyl 5 mg | oral bisacodyl |
| Usual care | No intervention | usual care for catheter insertion |
Sex: All, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Princess Margaret Hospital | Kwai Chung, Kowloon | Hong Kong | Not yet recruiting |
| Caritas Medical Centre | Sham Shui Po, Kowloon | Hong Kong | Not yet recruiting |
| Prince of Wales Hospital | Shatin, NT | Hong Kong | Recruiting |
| Tseung Kwan O Hospital | Tseung Kwan O, NT | Hong Kong | Not yet recruiting |
| Queen Elizabeth Hospital | Yau Ma Tei, NT | Hong Kong | Not yet recruiting |
| Prince of Wales Hospital | Shatin | Hong Kong | Not yet recruiting |