Bisacodyl Oral for Lowering Dysfunction (of Tenckhoff Catheter)

NCT07351357 — Phase 4, Recruiting, 398 participants, Chinese University of Hong Kong

ClinicalTrials Daily  ·  Areas  ·  Conditions  ·  Drugs  ·  Sponsors  ·  

Multi-Centre Pragmatic Randomized Controlled Trial of Bowel Preparation Before Peritoneal Dialysis Catheter Insertion

RegistryNCT07351357, acronym BOLD
StatusRecruiting
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: none, prevention
Enrollment398 (Estimated)
SponsorChinese University of Hong Kong (Other)
ConditionsRenal Failure Chronic Requiring Dialysis, Peritoneal Dialysis
InterventionsBisacodyl 5 mg (Drug)
Datesstart 2026-01-12, primary completion 2027-08-30 (estimated), completion 2027-09-30 (estimated), first posted 2026-01-20, last updated 2026-10-21
Locations6 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

-Summary

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.

Expand all sections  ·  Collapse all

+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.

+Arms and interventions

ArmTypeInterventionsDescription
Bowel preparationActive comparatorDrug: Bisacodyl 5 mgoral bisacodyl
Usual careNo interventionusual care for catheter insertion
  • Bisacodyl 5 mg (Drug): 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.

+Outcome measures

Primary outcomes

  • Catheter dysfunction [within 4 weeks of catheter insertion]: 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.

Secondary outcomes

  • Catheter dysfunction and survival [3 months after catheter insertion for early peritonitis]: The time to catheter dysfunction requiring invasive intervention
  • The incidence of early peritonitis (within 3 months of catheter insertion) [3 months after catheter insertion]: Peritonitis
  • The peritoneal catheter survival [3 months after catheter insertion]: catheter survival

+Eligibility

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

+Locations (6)

FacilityCityCountryStatus
Princess Margaret HospitalKwai Chung, KowloonHong KongNot yet recruiting
Caritas Medical CentreSham Shui Po, KowloonHong KongNot yet recruiting
Prince of Wales HospitalShatin, NTHong KongRecruiting
Tseung Kwan O HospitalTseung Kwan O, NTHong KongNot yet recruiting
Queen Elizabeth HospitalYau Ma Tei, NTHong KongNot yet recruiting
Prince of Wales HospitalShatinHong KongNot yet recruiting