Open Versus Percutaneous Insertion of CAPD Catheters

Official Title: “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”

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.

Intervention(s) in this Clinical Trial

• Procedure: Percutaneous Insertion catheter
  • Insertion of CAPD catheter using percutaneous seldinger technique under local anaesthetic +/- sedation as required
• Procedure: Open insertion Catheter
  • Present technique of open insertion under general anaesthetic. Incision to lower abdomen and direct visualisation of catheter tip placement into pelvis.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Percutaneous insertion
  • To undergo insertion of catheter using percutaneous technique under local anaesthetic
• Active Comparator: Open insertion
  • To undergo insertion of catheter using open technique under general anaesthetic

Primary Measures

• Catheter survival
  • Time Frame: Ongoing (recorded at 6 month intervals)
    Safety Issue?: No

Secondary Measures

• Peri operative complications (bleeding, bowel injury)
  • Time Frame: 24 hrs post procedure
    Safety Issue?: Yes
• Mechanical Complication (drainage failure, displacement, fluid leak)
  • Time Frame: ongoing (reported at 30 days and monthly thereafter)
    Safety Issue?: No
• Infective complications (exit site, tunnel, peritonitis)
  • Time Frame: ongoing (reported at 30 days and monthly thereafter)
    Safety Issue?: No
• Operative time
  • Time Frame: Average of 2 hours post procedure
    Safety Issue?: No
• Technical Success of placement
  • Time Frame: Average of 2 hours post procedure
    Safety Issue?: No
• Length of admission
  • Time Frame: Average of 48 hours post procedure
    Safety Issue?: No
• Patient reported pain post procedure
  • Time Frame: 24 hour intervals to 5 days post procedure
    Safety Issue?: No
• 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
    Safety Issue?: No
• Estimated cost of care episode
  • Time Frame: 3 months post procedure
    Safety Issue?: No

• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Hull Other

Overall Clinical Trial Officials and Contacts

Ian C Chetter, MB ChB Principal Investigator University of Hull  

Overall Contact: George E Smith, MBBS ++44 1482 674643 george.smith@hey.nhs/uk

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01023191

Study ID Number: Access 3

ClinicalTrials.gov Identifier: NCT01023191

Health Authority: United Kingdom: National Health Service