Open Versus Percutaneous Insertion of CAPD Catheters

NHS Trust

Status: Withdrawn

Conditions: Renal Failure

Treatments: Procedure: Open insertion Catheter; Procedure: Percutaneous Insertion catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT01023191

Access 3

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Percutaneous insertion

Active Comparator group

Description:

To undergo insertion of catheter using percutaneous technique under local anaesthetic

Treatment:

Procedure: Percutaneous Insertion catheter

Open insertion

Active Comparator group

Description:

To undergo insertion of catheter using open technique under general anaesthetic

Treatment:

Procedure: Open insertion Catheter