Laparoscopic Roux-en-Y gastric bypass (RYGB) is considered the ‘gold standard’ for surgical treatment of morbid obesity. It is hypothesised that reducing the length of the common limb positively affects the magnitude and preservation of weight loss but may also impose a risk of malnutrition. The aim of this study was to compare patients’ nutrient and vitamin deficiencies in standard RYGB with a very long Roux limb RYGB (VLRL-RYGB). This study was part of the multicentre randomised controlled trial (Dutch Common Channel Trial), including 444 patients undergoing an RYGB or a VLRL-RYGB. Laboratory results, use of multivitamin supplements and reoperations were collected at baseline and 1 year postoperative. Primary outcome measure was nutrient deficiency after 1 year postoperative. Secondary outcome measure was the reoperation rate due to malabsorption. In total, 227 patients underwent RYGB and 196 patients underwent VLRL-RYGB. Most common deficiencies at 1 year postoperative were ferritin (17·2–18·2 %), Fe (23·4–35·6 %), K (7·4–15·2 %), vitamin B12 (9·0–9·9 %) and vitamin D (22·7–34·5 %). Patients undergoing VLRL-RYGB had slightly but significantly lower levels of Ca, Fe and vitamin D compared with those undergoing RYGB at 1 year postoperative, but significantly higher levels of folic acid and Na. Reoperation rates due to malabsorption were not significantly different between RYGB (2/227, 0·9 %) and VLRL-RYGB (7/196, 3·6 %) (P = 0·088). We concluded that patients undergoing VLRL-RYGB had significantly lower levels of Ca, Fe and vitamin D compared with those undergoing RYGB at 1 year postoperative, but higher levels of folic acid and Na. Reoperation rates did not differ. Close monitoring on nutrient deficiencies should be performed in patients undergoing VLRL-RYGB.
IntroductionFast-track protocols often include short-term thromboprophylaxis and short length of hospital stay. These treatment strategies may negatively affect the occurrence and diagnosis of postoperative haemorrhage. Over the years, the rates of venous thromboembolic events (VTEs) have decreased, while there seems to be an increase in the occurrence of postoperative haemorrhage. Tranexamic acid (TXA) can potentially lower the incidence of postoperative haemorrhage. This trial aims to investigate whether preoperative administration of TXA reduces the preoperative and postoperative haemorrhage rates in laparoscopic sleeve gastrectomy (LSG).Methods and analysisThis is a single centre double-blind randomised placebo-controlled trial. Patients undergoing an LSG are included after obtaining informed consent. Patients are randomised between two groups: (1) administration of placebo infusion and (2) administration of 1500 mg TXA. In both groups, the infusions will be administered during the induction phase of the procedure. Primary outcome measures are preoperative use of haemostatic clips, postoperative haemoglobin decrease and postoperative haemorrhage. Secondary outcome measure is the rates of VTE.Ethics and disseminationThe protocol version 3 was approved by the medical ethical committee Medical Research Ethics Committees United (MEC-U), Nieuwegein, on 29 July 2019. The trial results will be submitted for publication in a peer-reviewed journal and at conference presentations.Trial registration numberThe Netherlands Trial Registry (NL8029); Pre-results.
Introduction In metabolic surgery, hemorrhage is the most common major complication. This study investigated whether peroperative administration of tranexamic acid (TXA) reduced the risk of hemorrhage in patients undergoing laparoscopic sleeve gastrectomy (SG). Methods In this double-blind randomized controlled trial, patients undergoing primary SG in a high-volume bariatric hospital were randomized (1:1) to receive 1500-mg TXA or placebo peroperatively. Primary outcome measure was peroperative staple line reinforcement using hemostatic clips. Secondary outcome measures were peroperative fibrin sealant use and blood loss, postoperative hemoglobin, heart rate, pain, major and minor complications, length of hospital stay (LOS), side effects of TXA (i.e., venous thrombotic event (VTE)) and mortality. Results In total, 101 patients were analyzed and received TXA (n = 49) or placebo (n = 52). There was no statistically significant difference in hemostatic clip devices used in both groups (69% versus 83%, p = 0.161). TXA administration showed significant positive changes in hemoglobin levels (millimoles per Liter; 0.55 versus 0.80, p = 0.013), in heart rate (beats per minute; -4.6 versus 2.5; p = 0.013), in minor complications (Clavien–Dindo ≤ 2, 2.0% versus 17.3%, p = 0.016), and in mean LOS (hours; 30.8 versus 36.7, p = 0.013). One patient in the placebo-group underwent radiological intervention for postoperative hemorrhage. No VTE or mortality was reported. Conclusion This study did not demonstrate a statistically significant difference in use of hemostatic clip devices and major complications after peroperative administration of TXA. However, TXA seems to have positive effects on clinical parameters, minor complications, and LOS in patients undergoing SG, without increasing the risk of VTE. Larger studies are needed to investigate the effect of TXA on postoperative major complications. Graphical abstract
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