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

January 17, 2026 updated by: Chow Kai Ming, Chinese University of Hong Kong

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

398

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Shatin, Hong Kong
        • Prince of Wales Hospital
    • Kowloon
      • Kwai Chung, Kowloon, Hong Kong, SAR
        • Princess Margaret Hospital
        • Contact:
      • Sham Shui Po, Kowloon, Hong Kong, SAR
        • Caritas Medical Centre
        • Contact:
    • NT
      • Shatin, NT, Hong Kong, SAR
      • Tseung Kwan O, NT, Hong Kong, SAR
        • Tseung Kwan O Hospital
        • Contact:
      • Yau Ma Tei, NT, Hong Kong, SAR
        • Queen Elizabeth Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Bowel preparation
oral bisacodyl
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.
No Intervention: Usual care
usual care for catheter insertion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Catheter dysfunction
Time Frame: 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.
within 4 weeks of catheter insertion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Catheter dysfunction and survival
Time Frame: 3 months after catheter insertion for early peritonitis
The time to catheter dysfunction requiring invasive intervention
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
Peritonitis
3 months after catheter insertion
The peritoneal catheter survival
Time Frame: 3 months after catheter insertion
catheter survival
3 months after catheter insertion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 12, 2026

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

September 30, 2027

Study Registration Dates

First Submitted

January 1, 2026

First Submitted That Met QC Criteria

January 10, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 17, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREC-2025-492

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Confidentiality

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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