Open Versus Percutaneous Insertion of CAPD Catheters

NCT01023191 | Withdrawn

• 1 other identifier: Access 3
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Failure

Keywords

Dialysis; Peritoneal; Catheter; Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Peri operative complications (bleeding, bowel injury)

  24 hrs post procedure

• Mechanical Complication (drainage failure, displacement, fluid leak)

  ongoing (reported at 30 days and monthly thereafter)

• Infective complications (exit site, tunnel, peritonitis)

  ongoing (reported at 30 days and monthly thereafter)

• Operative time

  Average of 2 hours post procedure

• Technical Success of placement

  Average of 2 hours post procedure

Study Arms (2)

Percutaneous insertion

ACTIVE COMPARATOR

To undergo insertion of catheter using percutaneous technique under local anaesthetic

Procedure: Percutaneous Insertion catheter

Open insertion

ACTIVE COMPARATOR

To undergo insertion of catheter using open technique under general anaesthetic

Procedure: Open insertion Catheter

Interventions

Percutaneous Insertion catheter PROCEDURE

Insertion of CAPD catheter using percutaneous seldinger technique under local anaesthetic +/- sedation as required

Percutaneous insertion

Open insertion Catheter PROCEDURE

Present technique of open insertion under general anaesthetic. Incision to lower abdomen and direct visualisation of catheter tip placement into pelvis.

Open insertion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred to vascular consultants for CAPD catheter insertion
• Ability to give informed written consent

You may not qualify if:

• Previous abdominal surgery via midline incision
• Unfit for general anaesthetic
• Aged under 18 at time of referral
• Inability to give informed written consent
• Inability to attend follow up appointments
• Withdrawal criteria:
• Patient request
• Patient non compliance with study protocol

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead
• University of Hull: collaborator

Study Sites (1)

Hull Royal Infirmary

Hull, East Yorkshire, HU3 2JZ, United Kingdom

Location

Related Publications (1)

• Briggs VR, Jacques RM, Fotheringham J, Maheswaran R, Campbell M, Wilkie ME. Catheter insertion techniques for improving catheter function and clinical outcomes in peritoneal dialysis patients. Cochrane Database Syst Rev. 2023 Feb 22;2(2):CD012478. doi: 10.1002/14651858.CD012478.pub2.

  PMID: 36810986 DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Ian C Chetter, MB ChB

  University of Hull

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2009
• First Posted: December 2, 2009
• Study Start: February 1, 2015
• Primary Completion: July 1, 2018
• Study Completion: September 1, 2018
• Last Updated: July 22, 2019

Record last verified: 2019-07

Locations

GB (1)