Radiological versus surgical implantation of catheter for peritoneal dialysis in the management of life-threatening end-stage kidney disease

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN92892834

Enrollment

113

Registered

2011-06-10

Start date

1999-04-01

Completion date

Unknown

Last updated

2016-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End-stage kidney disease (ESKD) Urological and Genital Diseases Kidney disease

Interventions

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 ran

). All the participants were followed for one year following catheter insertion.

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Secondary

Measure	Time frame
The occurrence of catheter removal and death from any cause	—

Primary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

New Zealand

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026