Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT01023191

Open Versus Percutaneous Insertion of CAPD Catheters

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

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Hull University Teaching Hospitals NHS Trust · Other Government
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREPercutaneous Insertion catheterInsertion of CAPD catheter using percutaneous seldinger technique under local anaesthetic +/- sedation as required
PROCEDUREOpen insertion CatheterPresent technique of open insertion under general anaesthetic. Incision to lower abdomen and direct visualisation of catheter tip placement into pelvis.

Timeline

Start date
2015-02-01
Primary completion
2018-07-01
Completion
2018-09-01
First posted
2009-12-02
Last updated
2019-07-22

Locations

1 site across 1 country: United Kingdom

Source: ClinicalTrials.gov record NCT01023191. Inclusion in this directory is not an endorsement.