Clinical trial NCT01023191: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Renal Failure
Keywords: Dialysis
Peritoneal
Catheter
Surgery
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: University of Hull
First posted: 2009-12-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Catheter survival
timeFrame: Ongoing (recorded at 6 month intervals)
Secondary outcomes:
measure: Peri operative complications (bleeding, bowel injury)
timeFrame: 24 hrs post procedure
measure: Mechanical Complication (drainage failure, displacement, fluid leak)
timeFrame: ongoing (reported at 30 days and monthly thereafter)
measure: Infective complications (exit site, tunnel, peritonitis)
timeFrame: ongoing (reported at 30 days and monthly thereafter)
measure: Operative time
timeFrame: Average of 2 hours post procedure
measure: Technical Success of placement
timeFrame: Average of 2 hours post procedure
measure: Length of admission
timeFrame: Average of 48 hours post procedure
measure: Patient reported pain post procedure
timeFrame: 24 hour intervals to 5 days post procedure
measure: Quality of life assessment by questionnaire
timeFrame: Within 24 hours prior to procedure, and again at both 5 days and 3 months post procedure
measure: Estimated cost of care episode
timeFrame: 3 months post procedure
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Hull Royal Infirmary
state: East Yorkshire
Study officials:
affiliation: University of Hull
name: Ian C Chetter, MB ChB
role: PRINCIPAL_INVESTIGATOR
References: