METHOD: A multicentre, parallel, randomised, controlled, open-label, non-inferiority trial was conducted. Adult patients receiving CAPD were randomised in a 1:1 ratio to SSL or STS. The primary outcome was the rate of peritonitis after 1 year of follow-up.
RESULTS: A total of 472 subjects were randomised (SSL, n = 233; STS, n = 239). One subject in each group was excluded from the analysis as they withdrew consent before the first dialysis dose. Four hundred and seventy subjects (SSL, n = 232; STS, n = 238) were included in the modified intention-to-treat analysis. Non-inferiority between two groups was established as no significant difference was found in peritonitis rate (incident rate ratio: 0.91, 95% CI: 0.65-1.28). No significant difference was detected in weekly Kt/V (p = 0.58) and creatinine clearance (p = 0.55). However, the average ultrafiltration volume was significantly lower in SSL, with a mean difference of 93 ml (p < 0.01). SSL also demonstrated a 2.57-times higher risk of device defect than STS (95% CI: 1.77-3.75).
CONCLUSION: SSL was non-inferior in peritonitis rate compared to plastic-free STS over 1 year in patients requiring CAPD. There was no difference in the delivered dialysis dose, but there was a higher rate of device defects with SSL.
SUMMARY: Nephrologist-initiated peritoneoscopic PD access programs have had a positive impact on PD penetration. The technique has been associated with a better primary success rate, superior catheter survival, less postoperative pain, shorter hospital stay, and shorter catheter break-in time compared with the conventional surgical technique. The role of interventional nephrologists in peritoneoscope Tenckhoff catheter placement is still perceived to be a relatively new advance, investigational by some, and many nephrologists and surgeons alike remain sceptical of the value of this recent option. Crucial questions often raised are how many procedures one needs to perform before being considered competent and who should be credentialed to perform the procedure or supervise trainees performing it. The evaluation of technical proficiency in a specific operation is difficult and complex. Cumulative summation (CUSUM) analysis is one option for tracking the success and failure of technical skill and examining trends over time. Key Messages: The author's facility has had good outcomes with a nephrologist-initiated peritoneoscopic PD access programme. Quality control of PD catheter insertion can be performed using CUSUM charting to monitor for primary catheter dysfunction, primary leak, and primary peritonitis.