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NCT Number: NCT07351357

Bisacodyl Oral for Lowering Dysfunction (of Tenckhoff Catheter)

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.

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Key information

Conditions

Renal Failure Chronic Requiring Dialysis Peritoneal Dialysis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Princess Margaret Hospital, Kwai Chung, Kowloon, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Catheter dysfunction and survival

    Time frame: 3 months after catheter insertion for early peritonitis

    The time to catheter dysfunction requiring invasive intervention

  2. The incidence of early peritonitis (within 3 months of catheter insertion)

    Time frame: 3 months after catheter insertion

    Peritonitis

  3. The peritoneal catheter survival

    Time frame: 3 months after catheter insertion

    catheter survival

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Acronym: BOLD

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 20, 2026
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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