Renal Failure
Conditions
Keywords
Dialysis, Peritoneal, Catheter, Surgery
Brief summary
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.
Interventions
PROCEDUREPercutaneous Insertion catheter
Insertion of CAPD catheter using percutaneous seldinger technique under local anaesthetic +/- sedation as required
PROCEDUREOpen insertion Catheter
Present technique of open insertion under general anaesthetic. Incision to lower abdomen and direct visualisation of catheter tip placement into pelvis.
Sponsors
University of Hull
Hull University Teaching Hospitals NHS Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Catheter survival | Ongoing (recorded at 6 month intervals) | Time to catheter removal for any reason.recorded as percentage inn situ at 6, 12,18,etc months post procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical Complication (drainage failure, displacement, fluid leak) | ongoing (reported at 30 days and monthly thereafter) | 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 |
| Infective complications (exit site, tunnel, peritonitis) | ongoing (reported at 30 days and monthly thereafter) | 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 |
| Operative time | Average of 2 hours post procedure | Time to complete procedure from start to finish. |
| Technical Success of placement | Average of 2 hours post procedure | Assessment of whether a working and useable catheter is in situ at the end of the procedure. |
| Peri operative complications (bleeding, bowel injury) | 24 hrs post procedure | All complications occuring at time of procedure and in 24 hours immediately post procedure. |
| Patient reported pain post procedure | 24 hour intervals to 5 days 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. |
| 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 | 3 months post procedure | Overall estimated cost of admission, procedure, ongoing care of catheter and management of complications arising from catheter or procedure will be calculated. |
| Length of admission | Average of 48 hours post procedure | Length of admission post procedure according to strict discharge criteria. |
Countries
United Kingdom
Outcome results
None listed