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ClinicalTrials.gov ID

NCT07351357

Lead Sponsor

Chinese University of Hong KongOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 4

Enrollment

398Estimated

Last Update Posted

Jan 21, 2026Actual

Start Date

Jan 12, 2026Estimated

Primary Completion Date

Aug 30, 2027Estimated

Completion Date

Sep 30, 2027Estimated

Official Title

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

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.

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.

• Renal Failure Chronic Requiring Dialysis
• Peritoneal Dialysis

• Bisacodyl 5 mg

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

Chinese University of Hong KongOTHER

yuensk@ha.org.hk852-51365610

chow_kai_ming@alumni.cuhk.net852-55696007

htlz01@ha.org.hk852-96225803

chw019@ha.org.hk852-61312675