Open Versus Percutaneous Insertion of CAPD Catheters

Not Applicable

Withdrawn

• Conditions: Renal Failure
• Interventions: Procedure: Percutaneous Insertion catheter; Procedure: Open insertion Catheter

• Registration Number: NCT01023191
• Lead Sponsor: Hull University Teaching Hospitals NHS Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-12-01
• Study First Submitted QC: 2009-12-01
• Study First Posted: 2009-12-02
• Study Start: 2015-02
• Primary Completion: 2018-07
• Study Completion: 2018-09
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-18
• Last Update Posted: 2019-07-22

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Percutaneous insertion	Percutaneous Insertion catheter	To undergo insertion of catheter using percutaneous technique under local anaesthetic
Open insertion	Open insertion Catheter	To undergo insertion of catheter using open technique under general anaesthetic

Primary Outcome Measures

Name	Time	Method
Catheter survival	Ongoing (recorded at 6 month intervals)	Time to catheter removal for any reason.recorded as percentage inn situ at 6, 12,18,etc months post procedure.

Secondary Outcome Measures

Name	Time	Method
Patient reported pain post procedure	24 hour intervals to 5 days 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.
Peri operative complications (bleeding, bowel injury)	24 hrs post procedure	All complications occuring at time of procedure and in 24 hours immediately post procedure.
Operative time	Average of 2 hours post procedure	Time to complete procedure from start to finish.
Length of admission	Average of 48 hours post procedure	Length of admission post procedure according to strict discharge criteria.
Infective complications (exit site, tunnel, peritonitis)	ongoing (reported at 30 days and monthly thereafter)	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
Quality of life assessment by questionnaire	Within 24 hours prior to procedure, and again at both 5 days and 3 months post procedure
Mechanical Complication (drainage failure, displacement, fluid leak)	ongoing (reported at 30 days and monthly thereafter)	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
Technical Success of placement	Average of 2 hours post procedure	Assessment of whether a working and useable catheter is in situ at the end of the procedure.
Estimated cost of care episode	3 months post procedure	Overall estimated cost of admission, procedure, ongoing care of catheter and management of complications arising from catheter or procedure will be calculated.

Trial Locations

Locations (1)

Hull Royal Infirmary; 🇬🇧 Hull, East Yorkshire, United Kingdom