Open Versus Percutaneous Insertion of CAPD Catheters

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by University of Hull.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Hull
ClinicalTrials.gov Identifier:
NCT01023191
First received: December 1, 2009
Last updated: July 14, 2011
Last verified: May 2010
  Purpose

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.


Condition Intervention
Renal Failure
Procedure: Percutaneous Insertion catheter
Procedure: Open insertion Catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Hull:

Primary Outcome Measures:
  • Catheter survival [ Time Frame: Ongoing (recorded at 6 month intervals) ] [ Designated as safety issue: No ]
    Time to catheter removal for any reason.recorded as percentage inn situ at 6, 12,18,etc months post procedure.


Secondary Outcome Measures:
  • Peri operative complications (bleeding, bowel injury) [ Time Frame: 24 hrs post procedure ] [ Designated as safety issue: Yes ]
    All complications occuring at time of procedure and in 24 hours immediately post procedure.

  • Mechanical Complication (drainage failure, displacement, fluid leak) [ Time Frame: ongoing (reported at 30 days and monthly thereafter) ] [ Designated as safety issue: No ]
    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

  • Infective complications (exit site, tunnel, peritonitis) [ Time Frame: ongoing (reported at 30 days and monthly thereafter) ] [ Designated as safety issue: No ]
    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

  • Operative time [ Time Frame: Average of 2 hours post procedure ] [ Designated as safety issue: No ]
    Time to complete procedure from start to finish.

  • Technical Success of placement [ Time Frame: Average of 2 hours post procedure ] [ Designated as safety issue: No ]
    Assessment of whether a working and useable catheter is in situ at the end of the procedure.

  • Length of admission [ Time Frame: Average of 48 hours post procedure ] [ Designated as safety issue: No ]
    Length of admission post procedure according to strict discharge criteria.

  • Patient reported pain post procedure [ Time Frame: 24 hour intervals to 5 days post procedure ] [ Designated as safety issue: No ]
    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.

  • Quality of life assessment by questionnaire [ Time Frame: Within 24 hours prior to procedure, and again at both 5 days and 3 months post procedure ] [ Designated as safety issue: No ]
  • Estimated cost of care episode [ Time Frame: 3 months post procedure ] [ Designated as safety issue: No ]
    Overall estimated cost of admission, procedure, ongoing care of catheter and management of complications arising from catheter or procedure will be calculated.


Estimated Enrollment: 124
Study Start Date: December 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01023191

Contacts
Contact: George E Smith, MBBS ++44 1482 674643 george.smith@hey.nhs/uk
Contact: Ian C Chetter, MB ChB ++44 1482 674643 ian.chetter@hey.nhs.uk

Locations
United Kingdom
Hull Royal Infirmary Not yet recruiting
Hull, East Yorkshire, United Kingdom, HU3 2JZ
Contact: Ian C Chetter, MBChB FRCS MD    +44 1482 674643    ian.chetter@hey.nhs.uk   
Contact: George E Smith, BSc MBBS MRCS    +44 1482 674643    george.smith@hey.nhs.uk   
Sponsors and Collaborators
University of Hull
Investigators
Principal Investigator: Ian C Chetter, MB ChB University of Hull
  More Information

No publications provided

Responsible Party: Mr IC Chetter, Hull University
ClinicalTrials.gov Identifier: NCT01023191     History of Changes
Other Study ID Numbers: Access 3
Study First Received: December 1, 2009
Last Updated: July 14, 2011
Health Authority: United Kingdom: National Health Service

Keywords provided by University of Hull:
Dialysis
Peritoneal
Catheter
Surgery

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Anesthetics, General
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014