An interventional study of Percutaneous Insertion catheter and Open insertion Catheter in Renal Failure, sponsored by Hull University Teaching Hospitals NHS Trust. Withdrawn at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-07-22.
Sponsored by Hull University Teaching Hospitals NHS Trust · Not applicable, Interventional, and Treatment
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.
1,995 studies on the registry are indexed under Renal Insufficiency; 173 are open to participants now.
Browse Renal Insufficiency studies →Hull University Teaching Hospitals NHS Trust is the lead sponsor of 93 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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;
General inclusion criteria:
Specific exclusion criteria:
General exclusion criteria:
Withdrawal criteria:
To undergo insertion of catheter using percutaneous technique under local anaesthetic
Procedure: Percutaneous Insertion catheter
To undergo insertion of catheter using open technique under general anaesthetic
Procedure: Open insertion Catheter
Insertion of CAPD catheter using percutaneous seldinger technique under local anaesthetic +/- sedation as required
Present technique of open insertion under general anaesthetic. Incision to lower abdomen and direct visualisation of catheter tip placement into pelvis.
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)
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
This study is withdrawn, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Hull University Teaching Hospitals NHS Trust