Open vs Laparoscopic CAPD catheter placement, a randomized controlled clinical trial

Completed

• Conditions: ierfunctiestoornis waarvoor CAPD; Renal failure peritoneal dialysis; 10029149; 10003184

• Registration Number: NL-OMON32970
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 120

Inclusion Criteria

Age between 18-85
Randomisation by computer
Suitable for both CAPD catheter and intervention strategies
Informed consent

Exclusion Criteria

Life expectancy < 1 year
Other intervention during the same surgical procedure
Loss of peritoneal function
No informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) Catheter survival: Number of patients with proper functioning catheter<br /><br>o After three months<br /><br>o After six months<br /><br>o After 1 year<br /><br><br /><br>2) 30-day or in-hospital mortality and long-term mortality</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Number of short and long-term post-operative complications<br /><br><br /><br>Short term complications:<br /><br>Bowel perforation, bleeding, wound infection, early peritonitis,<br /><br>malposition, outflow failure, dialysate leakage<br /><br><br /><br>Long term complications:<br /><br>Exit site infection, tunnel infection, cuff protrusion, malposition,<br /><br>outflow failure, dialysate leakage, hernias,<br /><br>peritonitis<br /><br><br /><br>2) Patency of CAPD catheter<br /><br><br /><br>* Primary patency (without interventions)<br /><br>* Primary assisted patency (with use of antibiotics)<br /><br>* Secondary patency (need for additional intervention)</p><br>