Condition category
Urological and Genital Diseases
Date applied
31/05/2011
Date assigned
10/06/2011
Last edited
20/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Kidney failure, also called end-stage kidney disease (ESKD), is the last stage of chronic kidney disease. When the kidneys fail, it means they have stopped working well enough for the patient to survive without dialysis or a kidney transplant. Not all people are able to undergo a kidney transplant, and dialysis remains an important treatment for most people with ESKD. Dialysis patients have many health problems, often require the assistance of health professionals (mainly doctors and nurses), are frequently admitted to hospital and require several operations. If the number of operations, complications and discomfort from multiple health care visits can be reduced, this will help to reduce the emotional trauma to people with ESKD. There are two types of dialysis: peritoneal dialysis (PD) and haemodialysis (HD). Both types of dialysis require access to the body’s blood to treat kidney failure. PD involves indirect access to the blood via the abdominal cavity (called the peritoneum), and requires a plastic tube (catheter) to be inserted through the abdominal wall into the peritoneum to allow a special fluid (dialysis fluid) to be drained in and out several times per day to “wash the blood” – taking over the job healthy kidneys do. The aim of this study is to test the success of a newer method of catheter insertion (radiological) to the standard method of catheter insertion (surgical). Before the study was done, it was thought that the radiological procedure (newer method) of insertion of the catheter would be a quicker and more cost-effective procedure, less stressful and less painful for participants when compared with the surgical method.

Who can participate?
Adult patients requiring PD for end-stage kidney disease

What does the study involve?
Participants are randomly allocated to undergo either the standard surgical method of catheter insertion (under general anaesthetic [asleep]) or the newer radiological method of catheter insertion (under local anaesthetic [awake]). All participants are then followed up for at least 12 months to observe the immediate success of the procedure of inserting the catheter, to ensure that it worked, and to look for and compare the complications from the two different insertion procedures. Common problems include failure of the catheter to work due to blockage or movement within the abdomen, infection of the tube entry point on the skin, infection within the abdomen, hernia, and fluid leaking in to the wall of the abdomen. Complications are recorded by the study nurse telephoning the patient at monitoring points in the follow-up year after the catheter insertion and up to four community or hospital visits in this follow-up time.

What are the possible benefits and risks of participating?
The study participation risks fell into two categories: those risks potentially associated with the newer method; and those associated with ESKD and PD treatment in general. Most of the risks in this study can potentially occur in all people on PD whether they are study participants or not. These risks included: inability to insert the catheter for whatever reason; allergic reactions to the antibiotics required to prevent infection at the time of catheter insertion; bleeding from the wound or around the tube (catheter); infection around the catheter entering the skin (exit site infection); infection within the abdominal cavity (peritonitis); leakage of fluid from within the abdominal cavity into the chest, groin or abdominal wall; hernia; pain following the procedure. The radiological method involves a small amount of radiation exposure (several seconds of screening in X-ray room).

Where is the study run from?
Counties Manukau District Health Board (CMDHB) (New Zealand)

When is the study starting and how long is it expected to run for?
April 1999 to August 2004

Who is funding the study?
Counties Manukau District Health Board (CMDHB) (New Zealand)

Who is the main contact?
Dr David Voss
dvoss@middlemore.co.nz

Trial website

Contact information

Type

Scientific

Primary contact

Dr David Voss

ORCID ID

Contact details

Counties Manukau DHB
Private Bag 93311
Otahuhu
Auckland
1640
New Zealand
+64 (0)2 166 4664
dvoss@middlemore.co.nz

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Radiological versus surgical implantation of catheter for peritoneal dialysis: a randomised non-inferiority trial

Acronym

Study hypothesis

The main objective of our study was to test the hypothesis that patients receiving peritonial dialysis (PD) catheters by radiological insertion technique (new intervention) had clinically equivalent outcomes to those by laparoscopic insertion (our standard) technique.

Ethics approval

Auckland Ethics Committee, February 1999, ref: 98/234 (committee 10)

Study design

Single-centre interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

End-stage kidney disease (ESKD)

Intervention

Participants were allocated by simple randomisation to receive the Baxter curl&reg catheter (Baxter Healthcare, McGaw Park, IL, USA) by either radiological or laparoscopic insertion technique. The randomisation procedure and treatment allocation was done by research staff not involved with the care of the participants, and performed before the initiation of dialysis. Randomisation allocations were stored in sequentially numbered opaque, sealed envelopes and were concealed and unavailable to investigators, study research staff and data entry staff at all points during the study. Because of the nature of the interventions, blinding of patients, providers, and data collectors was not possible.

After dialysis catheter insertion, all patients underwent continuous ambulatory PD using a Y-set system (Baxter Freeline solo®). All the participants were followed for one year following catheter insertion.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. The occurrence of dialysis catheter complications by day 365, a composite endpoint that included complications secondary to mechanical causes (insertion failure, inflow/outflow failure, herniae, dialysate leak including those through the exit site, the diaphragm, a patent processus vaginalis, or an abdominal hernia), or infectious causes (PD-related peritonitis, exit site infection, catheter tunnel infection).
1.1. The mechanical complications were defined according to standard clinical criteria, except herniae and dialysate leaks which were defined by confirmatory appearances on computed tomographic (CT) peritoneography.
1.2. The infectious complications were defined according to International Society of Peritoneal Dialysis (1996) criteria

Secondary outcome measures

The occurrence of catheter removal and death from any cause

Overall trial start date

01/04/1999

Overall trial end date

30/08/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participants were recruited from the outpatient clinic within the Counties Manukau District Health Board, South Auckland, New Zealand. Participants with severe or end-stage kidney disease were approached to participate in the study if they were offered and accepted PD as their renal replacement modality.
2. Individuals were eligible if they were over 18 years and suitable for both laparoscopic and radiological PD catheter insertion

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

113

Participant exclusion criteria

1. Severe obesity body mass index (BMI) > 35
2. Previous abdominal surgery or a history consistent with adhesions, severe medical co-morbidity precluding general anaesthesia, bleeding diatheses or anticoagulation
3. Human immunodeficiency virus (HIV) infection
4. Ongoing corticosteroid or immunosuppressant use
5. Severe psychiatric disease
6. Definite plans for live-donor kidney transplantation

Recruitment start date

01/04/1999

Recruitment end date

30/08/2004

Locations

Countries of recruitment

New Zealand

Trial participating centre

Counties Manukau District Health Board
Auckland
1640
New Zealand

Sponsor information

Organisation

Counties Manukau District Health Board (CMDHB) (New Zealand)

Sponsor details

Middlemore Hospital
c/o Dr David Voss
Hospital Road
Private Bag 93311
Otahuhu
Auckland
1640
New Zealand
+64 (0)2 166 4664
dvoss@middlemore.co.nz

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Counties Manukau District Health Board (CMDHB) (New Zealand)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22810376

Publication citations

  1. Results

    Voss D, Hawkins S, Poole G, Marshall M, Radiological versus surgical implantation of first catheter for peritoneal dialysis: a randomized non-inferiority trial., Nephrol. Dial. Transplant., 2012, 27, 11, 4196-4204, doi: 10.1093/ndt/gfs305.

Additional files

Editorial Notes

20/10/2016: Plain English summary added.