NCT07351357

Brief 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
398

participants targeted

Target at P75+ for phase_4

Timeline
17mo left

Started Jan 2026

Geographic Reach
1 country

6 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Jan 2026Sep 2027

First Submitted

Initial submission to the registry

January 1, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

January 12, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 20, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

1.6 years

First QC Date

January 1, 2026

Last Update Submit

January 17, 2026

Conditions

Renal Failure Chronic Requiring DialysisPeritoneal Dialysis

Keywords

peritoneal dialysisTenckhoff catheterlaxativebowel preparationcatheter dysfunction

Outcome Measures

Primary Outcomes (1)

  • Catheter dysfunction

    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 Outcomes (3)

  • Catheter dysfunction and survival

    3 months after catheter insertion for early peritonitis

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

    3 months after catheter insertion

  • The peritoneal catheter survival

    3 months after catheter insertion

Study Arms (2)

Bowel preparation

ACTIVE COMPARATOR

oral bisacodyl

Drug: Bisacodyl 5 mg

Usual care

NO INTERVENTION

usual care for catheter insertion

Interventions

Bisacodyl 5 mgDRUG

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.

Bowel preparation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 18 or older and need of peritoneal dialysis
  • willingness to give written consent and comply with the study protocol

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Princess Margaret Hospital

Kwai Chung, Kowloon, SAR, Hong Kong

Location

Caritas Medical Centre

Sham Shui Po, Kowloon, SAR, Hong Kong

Location

Prince of Wales Hospital

Shatin, NT, SAR, Hong Kong

Location

Tseung Kwan O Hospital

Tseung Kwan O, NT, SAR, Hong Kong

Location

Queen Elizabeth Hospital

Yau Ma Tei, NT, SAR, Hong Kong

Location

Prince of Wales Hospital

Shatin, Hong Kong

Location

MeSH Terms

Interventions

Bisacodyl

Intervention Hierarchy (Ancestors)

CresolsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

January 1, 2026

First Posted

January 20, 2026

Study Start

January 12, 2026

Primary Completion (Estimated)

August 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

January 21, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Confidentiality

Locations

HK(6)