Peroperative administration of tranexamic acid in Roux-en-Y and one-anastomosis gastric bypass to reduce haemorrhage in patients with morbid obesity: protocol for randomised controlled trial (PATRY trial).

INTRODUCTION: By implementation of Enhanced Recovery After Bariatric Surgery protocols and day-care surgery, early discharge poses a challenge if excessive bleeding occurs after bariatric surgery. Tranexamic acid (TXA) has demonstrated efficacy in other surgical fields and in bariatric pilot studies. This trial aims to assess the efficacy of peroperative administration of TXA in reducing haemorrhage in patients undergoing gastric bypass surgery. METHOD AND ANALYSIS: This is a multicentre, phase III, double-blind randomised controlled trial in six high-volume bariatric centres in the Netherlands. A total of 1524 eligible patients, aged 18 years or older, undergoing primary gastric bypass surgery (either Roux-en-Y gastric bypass or one-anastomosis gastric bypass) will be randomised between TXA and placebo (1:1, variable block, stratified for centre, day-care/overnight stay and type of surgery) after obtaining informed consent (2.5% less haemorrhage, power 80%, 2-sided-α 0.05 and 10% dropout). Exclusion criteria are pregnancy, amedical history of acute bleeding (without cause), venous thrombotic events (VTEs), epilepsy, anticoagulant use and iatrogenic bleeding during surgery (aside from staple line). The primary outcome is postoperative haemorrhage requiring intervention within 30 days postoperatively. Secondary outcome measures are staple line reinforcement, blood loss, duration of surgery, postoperative haemoglobin, vital parameters, minor and major complications, side effects of TXA (nausea, hypotension and VTE), length of hospital stay and directly made costs. ETHICS AND DISSEMINATION: Written informed consent will be obtained from all participants. The protocol has been approved by the Medical Research Ethics Committees United, Nieuwegein, on 7 February 2023 (registration number: R22.102). Results will be disseminated through peer-reviewed publications and conferences. TRIAL REGISTRATION NUMBER: NCT05464394.

Regional Collaboration and Trends in Clinical Management of Thyroid Cancer.

OBJECTIVE: This study examines the trends in the management of thyroid cancer and clinical outcomes in the Southwestern region of The Netherlands from 2010 to 2021, where a regional collaborative network has been implemented in January 2016. STUDY DESIGN: Retrospective cohort study. SETTING: This study encompasses all patients diagnosed with thyroid cancer of any subtype between January 2010 and June 2021 in 10 collaborating hospitals in the Southwestern region of The Netherlands. METHODS: The primary outcome of this study was the occurrence of postoperative complications. Secondary outcomes were trends in surgical management, centralization, and waiting times of patients with thyroid cancer. RESULTS: This study included 1186 patients with thyroid cancer. Median follow-up was 58 [interquartile range: 24-95] months. Surgery was performed in 1027 (86.6%) patients. No differences in postoperative complications, such as long-term hypoparathyroidism, permanent recurrent nerve paresis, or reoperation due to bleeding were seen over time. The percentage of patients with low-risk papillary thyroid carcinoma referred to the academic hospital decreased from 85% (n = 120/142) in 2010 to 2013 to 70% (n = 120/171) in 2014 to 2017 and 62% (n = 100/162) in 2018 to 2021 (P < .01). The percentage of patients undergoing a hemithyroidectomy alone was 9% (n = 28/323) in 2010 to 2013 and increased to 20% (n = 63/317; P < .01) in 2018 to 2021. CONCLUSION: The establishment of a regional oncological network coincided with a de-escalation of thyroid cancer treatment and centralization of complex patients and interventions. However, no differences in postoperative complications over time were observed. Determining the impact of regional oncological networks on quality of care is challenging in the absence of uniform quality indicators.

Long-Term Results of Laparoscopic Sleeve Gastrectomy for Morbid Obesity: 5 to 8-Year Results.

INTRODUCTION: Although long-term results of sleeve gastrectomy (LSG) remain scarce in the literature, its popularity as a stand-alone procedure has accounted for a global increase in LSG performance. In this retrospective study, the authors present 5 to 8-year follow-up results in terms of weight loss, failure/revision rate, and comorbidity resolution from a single center. MATERIALS AND METHODS: A prospectively maintained database was reviewed for patients who underwent LSG between 2007 and 2010. Data analysis on weight loss, comorbid conditions, revision surgery, and mortality was conducted. RESULTS: Median percentage excess BMI loss (%EBMIL) was 59.0, and 53.9 %, and median percentage total weight loss (%TWL) was 25.1, and 22.9 % at 5 and 8 years, respectively. Revision to gastric bypass due to insufficient weight loss or gastroesophageal reflux disease (GERD) was performed in 42 patients (15.2 %). Resolution of comorbid condition was achieved in 91 % of patients with obstructive sleep apnea syndrome (OSAS), 68 % of patients with type 2 diabetes (T2DM), 53 % of patients with hypertension, and 25 % of patients with dyslipedemia. Loss to follow-up rate was 45 % at 5 years, 28 % at 6 years, 23 % at 7 years, and 13 % at 8 years. CONCLUSION: This study adds to the currently available data confirming the LSG to be a safe and effective procedure at long term. Data from high-volume studies are needed to establish the definite role of the LSG in the spectrum of bariatric procedures.

Results of Implementing an Enhanced Recovery After Bariatric Surgery (ERABS) Protocol.

BACKGROUND: With the increasing prevalence of morbid obesity and healthcare costs in general, interest is shown in safe, efficient, and cost-effective bariatric care. This study describes an Enhanced Recovery After Bariatric Surgery (ERABS) protocol and the results of implementing such protocol on procedural times, length of stay in hospital (LOS), and the number of complications, such as readmissions and reoperations. METHODS: Results of implementing an ERABS protocol were analyzed by comparing a cohort treated according to the ERABS protocol (2012-2014) with a cohort treated before implementing ERABS (2010-2012). Differences between both cohorts were analyzed using independent t tests and chi-squared tests. RESULTS: A total of 1.967 patients (mean age 43.3 years, 80% female) underwent a primary bariatric procedure between 2010 and 2014, of which 1.313 procedures were performed after implementation of ERABS. A significant decrease of procedural times and a significantly decreased LOS, from 3.2 to 2.0 nights (p < 0.001), were seen after implementation of ERABS. Significantly more complications were seen post-ERABS (16.1 vs. 20.7%, p = 0.013), although no significant differences were seen in the number of major complications. CONCLUSION: Implementation of ERABS can result in shorter procedural times and a decreased LOS, which may lead to more efficient and cost-effective bariatric care. The increase in complications was possibly due to better registration of complications. The main goal of an ERABS protocol is efficient, safe, and evidence-based bariatric care, which can be achieved by standardization of the total process.