Open Versus Percutaneous Insertion of CAPD Catheters

Hull University Teaching Hospitals NHS Trust

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Renal Failure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Catheter survival

Time to catheter removal for any reason.recorded as percentage inn situ at 6, 12,18,etc months post procedure.

Time frame: Ongoing (recorded at 6 month intervals)

Secondary Outcomes

Peri operative complications (bleeding, bowel injury)

All complications occuring at time of procedure and in 24 hours immediately post procedure.

Time frame: 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

Time frame: 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

Time frame: ongoing (reported at 30 days and monthly thereafter)

Operative time

Time to complete procedure from start to finish.

Time frame: 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.

Time frame: Average of 2 hours post procedure

Length of admission

Length of admission post procedure according to strict discharge criteria.

Time frame: 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.

Time frame: 24 hour intervals to 5 days post procedure

Quality of life assessment by questionnaire

Time frame: 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.

Time frame: 3 months post procedure