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

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.

Study Overview

• Status: Withdrawn
• Conditions: Renal Failure
• Intervention / Treatment: Procedure: Percutaneous Insertion catheter; Procedure: Open insertion Catheter

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • East Yorkshire
    • Hull, East Yorkshire, United Kingdom, HU3 2JZ
      • Hull Royal Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Percutaneous insertion; To undergo insertion of catheter using percutaneous technique under local anaesthetic	Procedure: Percutaneous Insertion catheter; Insertion of CAPD catheter using percutaneous seldinger technique under local anaesthetic +/- sedation as required
Active Comparator: Open insertion; To undergo insertion of catheter using open technique under general anaesthetic	Procedure: Open insertion Catheter; Present technique of open insertion under general anaesthetic. Incision to lower abdomen and direct visualisation of catheter tip placement into pelvis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri operative complications (bleeding, bowel injury)	All complications occuring at time of procedure and in 24 hours immediately post procedure.	24 hrs post procedure
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)
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)
Operative time	Time to complete procedure from start to finish.	Average of 2 hours post procedure
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
Length of admission	Length of admission post procedure according to strict discharge criteria.	Average of 48 hours post procedure
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
Quality of life assessment by questionnaire		Within 24 hours prior to procedure, and again at both 5 days and 3 months post procedure
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

Collaborators and Investigators

• Sponsor: Hull University Teaching Hospitals NHS Trust
• Collaborators: University of Hull
• Investigators: Principal Investigator: Ian C Chetter, MB ChB, University of Hull

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Anticipated): July 1, 2018
• Study Completion (Anticipated): September 1, 2018

Study Registration Dates

• First Submitted: December 1, 2009
• First Submitted That Met QC Criteria: December 1, 2009
• First Posted (Estimate): December 2, 2009

Study Record Updates

• Last Update Posted (Actual): July 22, 2019
• Last Update Submitted That Met QC Criteria: July 18, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Surgery; Dialysis; Catheter; Peritoneal
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: Access 3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No