METHODS AND ANALYSIS: The study is an open-label randomised controlled trial. A total of 434 patients with end-stage renal disease undergoing CAPD will be enrolled and randomised to either the intervention group, Stay Safe Link, or the control group, Stay Safe. All study subjects will be followed up and monitored for 1 year. The primary safety outcome is the rate of peritonitis while the primary efficacy outcomes are the delivered dialysis dose and ultrafiltration volume.
ETHICS AND DISSEMINATION: The study was approved by the Medical Research Ethics Committee, National Institute of Health Malaysia. A written informed consent will be obtained from all participating subjects prior to any trial-related procedure and the study conduct will adhere strictly to Good Clinical Practice. The findings will be disseminated in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER: NCT03177031; Pre-results.
PATIENTS AND METHODS: The open, paramedian approach is the commonest technique to insert the 62-cm coiled double-cuffed Tenckhoff peritoneal catheter. All patients with catheters inserted between January 2004 and November 2007 were retrospectively analyzed for demographics and followed for up to 1 month for complications. We excluded patients whose catheters had been anchored to the bladder wall and who underwent concurrent omentectomy or readjustment without removal of a malfunctioning catheter (n = 7). Intravenous cloxacillin was the standard preoperative antibiotic prophylaxis. ♢
RESULTS: Over the 4-year study period, 384 catheters were inserted under local anesthetic into 319 patients [201 women (62.8%); mean age: 49.4 ± 16.7 years (range: 13 - 89 years); 167 (52.2%) with diabetes; 303 (95%) with end-stage renal disease] by 22 different operators. All Tenckhoff catheters were inserted by the general surgical (n = 223) or urology (n = 161) team. There were 29 cases (7.6%) of catheter migration, 22 (5.7%) of catheter obstruction without migration, 24 (6.3%) of exit-site infection, 12 (3.1%) of leak from the main incision, 14 (3.6%) of culture-proven wound infection, 11 (2.9%) post-insertion peritonitis, and 1 (0.3%) hemoperitoneum. No deaths were attributed to surgical mishap. ♢
CONCLUSIONS: The most common complication was catheter migration. The paramedian insertion technique was safe, with low complication rates.
METHODS: A retrospective record review of all CAPD patients on follow-up at the Miri Hospital, Sarawak, Malaysia from 2014 until 2017 was done.
RESULTS AND DISCUSSION: During the 4-year period, the overall peritonitis rate was 0.184 episodes per patient-year. Gram-positive and gram-negative bacteria each constituted one-third of the peritonitis; fungi (2.6%), Mycobacterium tuberculosis (MTB) (5.3%), polymicrobial (2.6%) and sterile culture (26.3%). The most commonly isolated gram-positive bacteria were coagulase-negative Staphylococcus. Our peritonitis rate is comparable to that of other centres i.e., Japan 0.195 and Indonesia 0.25. In comparison, countries like India (0.41), Korea (0.40) and Singapore (0.59) had relatively higher rate of PD-associated peritonitis. Two tuberculosis peritonitis patients died. The rate of catheter removal was approximately 20%. Gram-negative bacteria and MTB have a higher risk of catheter loss. About one-fifth used rainwater to clean their CAPD exit site. Out of this group, 33% did not boil the rainwater prior to usage.
CONCLUSION: Patient's characteristics and microbial susceptibility vary in different places of practice. The high rates of culture-negative peritonitis and high mortality risks associated with TB peritonitis warrant special attention. In patients with refractory peritonitis, early catheter removal is warranted in order to reduce mortality and minimize damage to peritoneal membrane.