Open Versus Percutaneous Insertion of CAPD Catheters

Renal Failure Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01023191
• Other study ID #: Access 3
• Status: Withdrawn
• Phase: N/A
• Start date: February 2015
• Est. completion date: September 2018

Study information

• Verified date: July 2019
• Source: Hull and East Yorkshire Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2018
• Est. primary completion date: July 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Renal Failure
• Renal Insufficiency

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Hull Royal Infirmary	Hull	East Yorkshire

Sponsors (2)

Lead Sponsor	Collaborator
Hull and East Yorkshire Hospitals NHS Trust	University of Hull

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Catheter survival	Time to catheter removal for any reason.recorded as percentage inn situ at 6, 12,18,etc months post procedure.	Ongoing (recorded at 6 month intervals)
Secondary	Peri operative complications (bleeding, bowel injury)	All complications occuring at time of procedure and in 24 hours immediately post procedure.	24 hrs post procedure
Secondary	Mechanical Complication (drainage failure, displacement, fluid leak)	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	ongoing (reported at 30 days and monthly thereafter)
Secondary	Infective complications (exit site, tunnel, peritonitis)	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	ongoing (reported at 30 days and monthly thereafter)
Secondary	Operative time	Time to complete procedure from start to finish.	Average of 2 hours post procedure
Secondary	Technical Success of placement	Assessment of whether a working and useable catheter is in situ at the end of the procedure.	Average of 2 hours post procedure
Secondary	Length of admission	Length of admission post procedure according to strict discharge criteria.	Average of 48 hours post procedure
Secondary	Patient reported pain 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.	24 hour intervals to 5 days post procedure
Secondary	Quality of life assessment by questionnaire		Within 24 hours prior to procedure, and again at both 5 days and 3 months post procedure
Secondary	Estimated cost of care episode	Overall estimated cost of admission, procedure, ongoing care of catheter and management of complications arising from catheter or procedure will be calculated.	3 months post procedure