Open Versus Percutaneous Insertion of CAPD Catheters

NCT ID: NCT01023191

Last Updated: 2019-07-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2018-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Percutaneous insertion

To undergo insertion of catheter using percutaneous technique under local anaesthetic

Group Type: ACTIVE_COMPARATOR

Percutaneous Insertion catheter

Intervention Type: PROCEDURE

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

Open insertion

To undergo insertion of catheter using open technique under general anaesthetic

Group Type: ACTIVE_COMPARATOR

Open insertion Catheter

Intervention Type: PROCEDURE

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

Interventions

Percutaneous Insertion catheter

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

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients referred to vascular consultants for CAPD catheter insertion

• Ability to give informed written consent

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Hull

OTHER

Sponsor Role: collaborator

Hull University Teaching Hospitals NHS Trust

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ian C Chetter, MB ChB

Role: PRINCIPAL_INVESTIGATOR

University of Hull

Locations

Hull Royal Infirmary

Hull, East Yorkshire, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 36810986 (View on PubMed)

Other Identifiers

Access 3

Identifier Type: -

Identifier Source: org_study_id