Ignite Creation Date:
2024-05-05 @ 10:04 PM
Last Modification Date:
2024-10-26 @ 10:13 AM
Study NCT ID:
NCT01023191
Status:
WITHDRAWN
Last Update Posted:
2019-07-22
First Post:
2009-12-01
Brief Title:
Open Versus Percutaneous Insertion of CAPD Catheters
Sponsor:
Hull University Teaching Hospitals NHS Trust
Organization:
Hull University Teaching Hospitals NHS Trust
Study Overview
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
Status:
WITHDRAWN
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Did not pass set-up phase
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None