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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bowel preparation | Active Comparator | oral bisacodyl |
|
| Usual care | No Intervention | usual care for catheter insertion |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Catheter dysfunction and survival | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Hospital | Kwai Chung | Kowloon | SAR | Hong Kong |
Confidentiality
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| ID | Term |
|---|---|
| D001726 | Bisacodyl |
| ID | Term |
|---|---|
| D003408 | Cresols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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|
Peritonitis
| 3 months after catheter insertion |
| The peritoneal catheter survival | catheter survival | 3 months after catheter insertion |
| Caritas Medical Centre | Sham Shui Po | Kowloon | SAR | Hong Kong |
|
| Prince of Wales Hospital | Shatin | NT | SAR | Hong Kong |
|
| Tseung Kwan O Hospital | Tseung Kwan O | NT | SAR | Hong Kong |
|
| Queen Elizabeth Hospital | Yau Ma Tei | NT | SAR | Hong Kong |
|
| Prince of Wales Hospital | Shatin | Hong Kong |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |