Open Versus Percutaneous Insertion of CAPD Catheters

Study Overview
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Brief Summary
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Healthy kidneys clean your blood by removing excess fluid, minerals, and wastes. When your kidneys fail, harmful wastes build up in your body and your body may retain excess fluid. When this happens, you need treatment to replace the work of your failed kidneys. This may be with a dialysis machine using haemodialysis or with fluid in the abdomen or peritoneal dialysis. In peritoneal dialysis, a tube called a catheter is put in the abdomen wall and used to fill your abdomen with a cleansing liquid called dialysis solution. The walls of your abdominal cavity are lined with a membrane called the peritoneum, which allows waste products and extra fluid to pass from your blood into the dialysis solution. These wastes and fluid are removed from the body when the dialysis fluid is drained and replaced with a fresh solution. The tubes or catheters used to exchange the fluid are currently positioned using a general anaesthetic (with the patient awake) and an operation with a cut under the belly button. Newer techniques using local anaesthetic (with the patient awake and the area numbed) and requiring only a small cut in the skin have been used. No one has ever directly compared the two techniques. The investigators aim is to perform a direct comparison between the two techniques to look at the complications and time required for surgery and length of hospital stay required. The investigators will also look at the patients satisfaction and pain scores with each technique to help gather evidence as to which is likely to be the best technique to use from now on.

Official Title
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A Prospective Randomized Controlled Trial of Local Anaesthetic Percutaneous Insertion Versus General Anaesthetic Open Surgical Placement of Continuous Peritoneal Dialysis Catheters in a University Teaching Hospital

Conditions
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Renal Failure

Intervention / Treatment
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* Procedure: Percutaneous Insertion catheter
* Procedure: Open insertion Catheter


Participation Criteria
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Eligibility Criteria
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Potential participating patients will be identified by referral to the vascular surgery department for insertion of CAPD catheter for peritoneal access. Specific inclusion criteria necessary for invitation to study participation; Patients referred to vascular consultants for CAPD catheter insertion General inclusion criteria: Ability to give informed written consent Specific exclusion criteria: Previous abdominal surgery via midline incision Unfit for general anaesthetic Aged under 18 at time of referral General exclusion criteria: Inability to give informed written consent Inability to attend follow up appointments Withdrawal criteria: Patient request Patient non compliance with study protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Percutaneous insertion<br>To undergo insertion of catheter using percutaneous technique under local anaesthetic | Procedure: Percutaneous Insertion catheter<br>* Insertion of CAPD catheter using percutaneous seldinger technique under local anaesthetic +/- sedation as required<br>|
| Active Comparator: Open insertion<br>To undergo insertion of catheter using open technique under general anaesthetic | Procedure: Open insertion Catheter<br>* Present technique of open insertion under general anaesthetic. Incision to lower abdomen and direct visualisation of catheter tip placement into pelvis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Catheter survival | Time to catheter removal for any reason.recorded as percentage inn situ at 6, 12,18,etc months post procedure. | Ongoing (recorded at 6 month intervals) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peri operative complications (bleeding, bowel injury) | All complications occuring at time of procedure and in 24 hours immediately post procedure. | 24 hrs post procedure | 
| Mechanical Complication (drainage failure, displacement, fluid leak) | All mechanical complications recorded during follow up period. Note of timing of complications will be made in results. Early = within 30 days, late = beyond 30 days | ongoing (reported at 30 days and monthly thereafter) | 
| Infective complications (exit site, tunnel, peritonitis) | All infective complications recorded during follow up period. Note of timing of complications will be made in results. Early = within 30 days, late = beyond 30 days | ongoing (reported at 30 days and monthly thereafter) | 
| Operative time | Time to complete procedure from start to finish. | Average of 2 hours post procedure | 
| Technical Success of placement | Assessment of whether a working and useable catheter is in situ at the end of the procedure. | Average of 2 hours post procedure | 
| Length of admission | Length of admission post procedure according to strict discharge criteria. | Average of 48 hours post procedure | 
| Patient reported pain post procedure | Analgesia and daily pain scoring diaries will be issued to patients post procedure. These will record patient reported pain at 24 hour intervals to 5 days as well as analgesia taken during the same period. | 24 hour intervals to 5 days post procedure | 
| Quality of life assessment by questionnaire |  | Within 24 hours prior to procedure, and again at both 5 days and 3 months post procedure | 
| Estimated cost of care episode | Overall estimated cost of admission, procedure, ongoing care of catheter and management of complications arising from catheter or procedure will be calculated. | 3 months post procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dialysis, Peritoneal, Catheter, Surgery