Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study compares the result of straight versus coiled Tenckhoff catheters for peritoneal dialysis patients. Recent meta-analysis of the peritoneal dialysis catheter type was in favor of straight catheters. The effects of straight versus coiled peritoneal dialysis catheters, however, are unclear. The investigators design an adequately powered randomized controlled study to evaluate the two types of double-cuffed peritoneal dialysis catheters. The primary objective is to assess whether straight peritoneal dialysis catheters can reduce the risk of catheter dysfunction that requires intervention. The investigators estimate that they would need to enroll 132 incident peritoneal dialysis patients in each group for the study to have 80% power to detect a difference between 7% and 15% in the primary endpoint of catheter dysfunction requiring intervention.
The objective of the present study is to evaluate the a priori hypothesis that straight peritoneal dialysis catheters would improve the treatment outcomes of peritoneal dialysis. The early and late catheter complications, as well as catheter survival, will be compared between peritoneal dialysis patients who are randomized to straight and coiled Tenckhoff catheters.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Straight Tenckhoff catheter | Active Comparator | Tenckhoff catheter with straight intra-abdominal part |
|
| Coiled Tenckhoff catheter | Active Comparator | Tenckhoff catheter with coiled intra-abdominal part |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenckhoff catheter | Device | Peritoneal dialysis catheters for long term use |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of catheter dysfunction that requires intervention | Catheter dysfunction refers to drainage failure, as defined by the inability to drain peritoneal dialysate effluent reliably within 45 minutes. Intervention includes catheter repositioning or reinsertion, either by open surgical method or laparoscopically | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Time to catheter dysfunction requiring intervention | see above | One year |
| Dialysis catheter migration with dysfunction | Dialysis catheter tip located above the pelvic brim on the abdominal radiograph |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kai Ming Chow, MBChB, FRCP | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital, Chinese University of Hong Kong | Shatin | New Territories | SAR | Hong Kong | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31445925 | Derived | Chow KM, Wong SSM, Ng JKC, Cheng YL, Leung CB, Pang WF, Fung WWS, Szeto CC, Li PKT. Straight Versus Coiled Peritoneal Dialysis Catheters: A Randomized Controlled Trial. Am J Kidney Dis. 2020 Jan;75(1):39-44. doi: 10.1053/j.ajkd.2019.05.024. Epub 2019 Aug 21. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
straight versus coiled Tenckhoff catheters
Not provided
Not provided
Not provided
Not provided
| One year |
| Infusion pain | Patient will be questioned on infusion pain around one month after starting peritoneal dialysis | One month |
| Risk of peritonitis | One year |
| Technique failure | One year |
| Peritoneal dialysis catheter survival | One year |
| Alice Ho Miu Ling Nethersole Hospital |
| Tai Po |
| Hong Kong |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |