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.
METHODS: Between November 2005 and November 2006, the technique was applied in 18 patients (6 female, 12 male; median age 50 years, range 16 - 73 years) on continuous ambulatory peritoneal dialysis with catheter malfunction secondary to omental wrap. Pneumoperitoneum was induced under general anesthesia. Three ports were inserted. The catheter was released from the omentum and repositioned in the pelvis. The omentum was then folded onto itself in a cephalad direction using silk sutures. This shortened the omentum. The risk of catheter migration was minimized with a polypropylene sling passed through the abdominal wall and around the catheter, then knotted subcutaneously. The sling allowed catheter removal without a new laparoscopy. The outcomes were prospectively evaluated.
RESULTS: Median operating time was 90 minutes (range 35 - 160 minutes). Adhesiolysis was performed in 4 patients: 1 patient had port-site leakage of dialysate, which settled with abdominal rest; 1 patient had bleeding during adhesiolysis and laparoscopic hemostasis was successful; 1 patient had recurrent catheter obstruction 2 weeks post-operatively and was converted to hemodialysis; and 1 patient had recurrent malfunction secondary to small bowel wrap after 5.5 months; re-salvage was successful. The success rate of the first salvage procedure was 89%(16/18). The catheters were still functioning after a mean follow-up of 16.5 +/- 6.3 months (range 0.5 - 24 months). The 1-year catheter survival rate was 83.3%.
CONCLUSIONS: Omental folding is a safe and effective technique for salvaging peritoneal dialysis catheters.
DESIGN: This multicenter, parallel group, randomized controlled trial involved 363 prevalent CAPD patients from 8 centers. The primary endpoint was peritonitis rate; secondary endpoints were technique failure and technical problems encountered. The duration of the evaluation was 1 year.
RESULTS: The risk of peritonitis on Carex varied between the centers. We found a significant treatment-center interaction effect (likelihood ratio test: p = 0.03). The incidence rate ratio (IRR) of peritonitis on Carex as compared with Ultra ranged from 0.4 to 7.2. In two centers, Carex was inferior to Ultra with regard to peritonitis; but, in five centers, the results were inconclusive. Equivalence was not demonstrated in any center. The overall rate of peritonitis in the Carex group was twice that in the Ultra group [IRR: 2.18; 95% confidence interval (CI): 1.51 to 3.14]. Technique failure and technical problems were more common with the Carex system. Technique failure rate at 1 year was 44% in the Carex group and 22% in the Ultra group.
CONCLUSIONS: Equivalence between the Carex disconnect system and the Ultra disconnect system could not be demonstrated. The risk of peritonitis on Carex varied significantly between centers.
METHODS: A cost utility study of hemodialysis (HD) and continuous ambulatory peritoneal dialysis (CAPD) was conducted from a Ministry of Health (MOH) perspective. A Markov model was also developed to investigate the cost effectiveness of increasing uptake of incident CAPD to 55% and 60% versus current practice of 40% CAPD in a five-year temporal horizon. A scenario with 30% CAPD was also measured. The costs and utilities were sourced from published data which were collected as part of this study. The transitional probabilities and survival estimates were obtained from the Malaysia Dialysis and Transplant Registry (MDTR). The outcome measures were cost per life year (LY), cost per quality adjusted LY (QALY) and incremental cost effectiveness ratio (ICER) for the Markov model. Sensitivity analyses were performed.
RESULTS: LYs saved for HD was 4.15 years and 3.70 years for CAPD. QALYs saved for HD was 3.544 years and 3.348 for CAPD. Cost per LY saved was RM39,791 for HD and RM37,576 for CAPD. The cost per QALY gained was RM46,595 for HD and RM41,527 for CAPD. The Markov model showed commencement of CAPD in 50% of ESRD patients as initial dialysis modality was very cost-effective versus current practice of 40% within MOH. Reduction in CAPD use was associated with higher costs and a small devaluation in QALYs.
CONCLUSIONS: These findings suggest provision of both modalities is fiscally feasible; increasing CAPD as initial dialysis modality would be more cost-effective.
PURPOSE: We set out to describe the reproductive health issues in women being treated with either hemodialysis (HD) or continuous ambulatory peritoneal dialysis (CAPD).
PATIENTS AND METHODS: All adult female patients on chronic dialysis in Hospital Seremban from January 1991 to December 2001 were included in our study. Patients (or their spouses or children) were interviewed regarding the menstrual status of the patient, gynecologic screening tests administered to the patient, and the patient's use of hormone replacement therapy (HRT).
RESULTS: We recruited 137 women into the study. Of those women, 52.6% were on HD; the rest were on CAPD. Mean age at diagnosis of ESRD was 46.5 +/- 14.1 years (range: 14 - 82 years), and mean duration on dialysis was 33.3 months (range: 2 months - 18 years). Responses about menstrual status were obtained for 118 patients. Of those 118 patients, 55 (46.6%) were postmenopausal at dialysis initiation. Average age at menopause had been 48.5 +/- 4.9 years. Another 19 patients (16.1%) had still been menstruating at dialysis initiation, but subsequently entered menopause. Their average age at menopause had been 45.1 +/- 10.3 years. The remaining 44 patients (37.3%) were still menstruating at an average age of 35.7 years (range: 15 - 49 years). Only 3 of 73 responders were on HRT; 63% had undergone a Pap smear; and 54% had had a breast examination.
CONCLUSIONS: Patients with ESRD tend to experience premature menopause. Not all dialysis patients are amenorrheic. Despite frequent contact between dialysis patients and hospital staff, gynecologic screening and use of HRT in those patients are still very low.