Peritoneal Dialysis Catheter Function

Study Overview
=================
Brief Summary
-----------------
The straight Tenckhoff is the most common catheter for peritoneal dialysis. A new, more expensive,self-locating catheter with a heavy tip has been developed by Di Paolo. The investigators used these catheters in parallel for several years. To clarify what catheter has least problems the investigators performed a comparative study to clarify if outflow problems differed between these catheters.

Detailed Description
-----------------
The straight Tenckhoff catheter (sT) is the most common used catheter for peritoneal dialysis (PD). A new, more expensive, self-locating catheter (sLC) has been developed by Di Paolo. The investigators had used both in parallel for several years. To clarify what catheter to focus on in the future the investigators performed a comparative study to clarify if outflow problems differed between these catheters. Study design: interventional and randomized at the same hospital Patients: Patients that were planned to start PD were informed and asked to participate in the randomized study. All patients who were asked accepted and consented to be included in the investigation. At the investigators hospital, insertion of pertitnoean dialysis catheters is performed by open surgery. This is performed using a three layer suture technique performed in local anesthesia. The technique enables immediate start of dialysis after surgery. Outflow problems were defined as a delay of flow of more than 40 minutes for 500ml of PD fluid. The duration of time was calculated by months on PD. Patients who died, were transplanted or changed for hemodialysis were censored. End-point was an insufficient drainage/flow of dialysis fluid that unabled adequate dialysis and intervention (by surgery) was necessary to correct/change catheter. Statistical analyses used were Breslow test and Kaplan Meier survival curve.

Official Title
-----------------
Comparison of Self-locating Catheter Versus a Straight Catheter for Outflow Problems.

Conditions
-----------------
Peritoneal Dialysis

Intervention / Treatment
-----------------
* Device: Self-locating Catheter
* Device: straight Tenckhoff


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive patients that are eligible and planned to start peritoneal dialysis and thereafter accept to be part of the study. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: straight Tenckhoff<br>The straight Tenckhoff catheter (sT) is the most common used catheter for peritoneal dialysis (PD). | Device: straight Tenckhoff<br>* Procedure/Surgery necessary if obstruction occurs<br>|
| Active Comparator: self-locating catheter<br>A new, more expensive, self-locating catheter (sLC) has been developed by Di Paolo. | Device: Self-locating Catheter<br>* Procedure/Surgery necessary if obstruction occurs<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insufficient drainage/flow of dialysis fluid that unabled adequate dialysis |  | 12 Months |