One-Year Outcomes in a Supervised Program of Swallowable Intragastric Balloon-Analysis of 486 Patients in a High-Volume Bariatric Centre in Malaysia.

INTRODUCTION: The swallowable intragastric balloon (IGB) has recently emerged as a popular alternative for weight loss in Malaysia. It can reduce total body weight loss (TBWL) by 6-15%. We aim to observe positive weight loss up to a year after the swallowable IGB is implanted. METHODS: A total of 486 consecutive patients with overweight or obesity who underwent swallowable IGB insertion were included in this prospective data collection. RESULTS: Out of 486 patients, 404 patients (83%) had complete data at the end of 4 and 12 months. Patients included in the study had a starting mean body mass index of 35.3 ± 7.2 kg/m2 which decreased to 31.5 ± 5.7 kg/m2 (p < 0.0001) at the end of 4 months and further reduced to 30.3 ± 5.4 kg/m2 (p < 0.0001) at the end of 12 months. At 4 months, the overall average weight loss was 9.8 kg, meanwhile, at 12 months, the average weight loss increased to 12.9 kg. At 4 months, the average TBWL was 10.5%, while at the end of 1 year, the combined %TBWL increased to 13.7%. CONCLUSION: Most weight loss is typically observed within the first 4 months following the procedure. However, it is important to note that patients can continue to experience ongoing weight loss for up to 1 year. The swallowable IGB is a safe and effective option for patients seeking weight loss solutions. It offers numerous advantages, especially its non-invasive procedureless nature, which makes it more appealing to individuals considering this treatment.

Impact of intrapatient variability (IPV) in tacrolimus trough levels on long-term renal transplant function: multicentre collaborative retrospective cohort study protocol.

INTRODUCTION: High intrapatient variability (IPV) in tacrolimus trough levels has been shown to be associated with higher rates of renal transplant failure. There is no consensus on what level of IPV constitutes a risk of graft loss. The establishment of such a threshold could help to guide clinicians in identifying at-risk patients to receive targeted interventions to improve IPV and thus outcomes. METHODS AND ANALYSIS: A multicentre Transplant Audit Collaborative has been established to conduct a retrospective study examining tacrolimus IPV and renal transplant outcomes. Patients in receipt of a renal transplant at participating centres between 2009 and 2014 and fulfilling the inclusion criteria will be included in the study. The aim is to recruit a minimum of 1600 patients with follow-up spanning at least 2 years in order to determine a threshold IPV above which a renal transplant recipient would be considered at increased risk of graft loss. The study also aims to determine any national or regional trends in IPV and any demographic associations. ETHICS AND DISSEMINATION: Consent will not be sought from patients whose data are used in this study as no additional procedures or information will be required from participants beyond that which would normally take place as part of clinical care. The study will be registered locally in each participating centre in line with local research and development protocols. It is anticipated that the results of this audit will be disseminated locally, in participating NHS Trusts, through national and international meetings and publications in peer-reviewed journals.

A comparison of the effects of oral vs. intravenous hydration on subclinical acute kidney injury in living kidney donors: a protocol of a randomised controlled trial.

BACKGROUND: Optimal treatment for established renal failure is living donor kidney transplantation. However this pathway exposes healthy individuals to significant reduction in nephron mass via major surgical procedure. Laparoscopic donor nephrectomy is now the most common method for live donor transplantation, reducing both donor post-operative pain and recovery time. However this procedure exposes kidneys to additional haemodynamic stresses. It has been suggested that donor hydration-particularly the use of preoperative intravenous fluids-may counteract these stresses, reducing subclinical acute kidney injury and ultimately improving long-term renal function. This may be important in both preservation of donor renal function and recipient graft longevity. METHODS/DESIGN: A prospective single-centre single-blinded randomized controlled trial will be carried out to determine the effects of donor preoperative intravenous fluids. The primary outcome is donor subclinical acute kidney injury (defined as plasma NGAL, >153 ng/ml) on day 1 postoperatively. Secondary outcomes include intraoperative haemodynamics, recipient subclinical acute kidney injury, perioperative complications and donor sleep quality. Donors will be randomised into two groups: the intervention group will receive active pre-hydration consisting of three litres of intravenous Hartmann's solution between midnight and 8 am before morning kidney donation, while the control group will not receive this. Both groups will receive unlimited oral fluids until midnight, as is routine. Plasma NGAL will be measured at pre-specified perioperative time points, intraoperative haemodynamic data will be collected using non-invasive cardiac output monitoring and clinical notes will be used to obtain demographic and clinical data. The researcher will be blinded to the donor fluid hydration status. Blinded statistical analysis will be performed on an intention-to-treat basis. A prospective power calculation estimates a required sample size of 86 patients. DISCUSSION: This study will provide important data, as there is currently little evidence about the use of donor preoperative fluids in laparoscopic nephrectomy. It is hoped that the results obtained will guide future clinical practice. TRIAL REGISTRATION: This study has been approved by the West of Scotland Research Ethics Committee 3 (reference no. 14/WS/1160, 27 January 2015) and is registered with the International Standard Randomised Controlled Trial Number Register (reference no. ISRCTN10199225 , 20 April 2015).