Effect of Different Modalities of Purgative Preparation on the Diagnostic Yield of Small Bowel Capsule for the Exploration of Suspected Small Bowel Bleeding: A Multicenter Randomized Controlled Trial
The American journal of gastroenterology. 2022
INTRODUCTION The aim of our study was to compare clear liquid diet with 2 different polyethylene glycol (PEG)-based bowel preparation methods regarding diagnostic yield of small bowel capsule endoscopy (SBCE) in patients with suspected small bowel bleeding (SBB). METHODS In this prospective multicenter randomized controlled trial, consecutive patients undergoing SBCE for suspected SBB between September 2010 and February 2016 were considered. Patients were randomly assigned to standard regimen, that is, clear fluids only (prep 1), standard regimen plus 500 mL PEG after SBCE ingestion (prep 2), or standard regimen plus 2 L PEG plus 500 mL PEG after SBCE ingestion (prep 3). The primary outcome was the detection of at least one clinically significant lesion in the small bowel. The quality of small bowel cleansing was assessed. A questionnaire on the clinical tolerance was filled by the patients. RESULTS We analyzed 834 patients. No significant difference was observed for detection of P1 or P2 small bowel lesions between prep1 group (40.5%), prep 2 group (40.2%), and prep 3 group (38.5%). Small bowel cleansing was improved in prep 2 and 3 groups compared with that in prep 1 group. Compliance to the preparation and tolerance was better in prep 2 group than in prep 3 group. DISCUSSION Small bowel purgative before SBCE allowed better quality of cleansing. However, it did not improve diagnostic yield of SBCE for suspected SBB.
Tranexamic acid vs placebo and its impact on bleeding, transfusions and stone-free rates in percutaneous nephrolithotomy: a systematic review and meta-analysis
Central European journal of urology. 2022;75(1):81-89
INTRODUCTION Percutaneous nephrolithotomy (PCNL) is the standard of care for the treatment of large renal stones. Bleeding-related complications remain a major concern when performing this procedure. Tranexamic acid (TXA) has recently been studied in both urologic and non-urologic procedures to reduce bleeding, transfusions and complications. MATERIAL AND METHODS In June 2021 a systematic review was conducted following PRISMA guidelines on randomized prospective studies comparing the effects of TXA on bleeding complications during PCNL. Data was analyzed using Review Manager 5.3. RESULTS Eight studies were included with a total 1,201 patients, of which 598 received TXA and 603 received placebo. TXA was associated with less bleeding (decreased change in hemoglobin) -0.79 Hb g/dl [-1.09, -0.65] p <.00001 and decreased transfusion rates (OR 0.31 [0.18, 0.52] p <0.0001). This was also associated with lower complication rates, both minor, major and overall, OR 0.59[0.41, .85] p = 0.005, OR 0.31 [0.17, 0.56] p = 0.0001 and OR 0.40 [0.29, 0.56] p <0.00001 respectively. TXA was also associated with improved stone-free rates as compared with placebo (OR 1.79 [1.23, 2.62] p = 0.003). TXA resulted in shorter operative times (11.51 minutes [-16.25, -6.77] p =.001) and length of stay (-0.74 days [-1.13 -0.34] p = 0.0006). Two pulmonary embolisms were registered in a single study in the TXA group. CONCLUSIONS In this meta-analysis, the use of TXA during PCNL was associated with a statistically significant reduction in the following parameters when compared with placebo: change in hemoglobin, transfusion rates, complication rates, operative time, and length of stay. It was also associated with improvement in stone-free rates. These data should be considered by surgeons performing PCNL.
Clinical Outcomes of Negative Balloon-Assisted Enteroscopy for Obscure Gastrointestinal Bleeding: A Systematic Review and Meta-Analysis
Frontiers in medicine. 2022;9:772954
BACKGROUND For patients with obscure gastrointestinal bleeding (OGIB), finding the bleeding site is challenging. Balloon-assisted enteroscopy (BAE) has become the preferred diagnostic modality for OGIB. The long-term outcome of patients with negative BAE remains undefined. The present study aimed to evaluate the long-term outcomes of patients with negative BAE results for OGIB and to clarify the effect of further investigations at the time of rebleeding with a systematic review and meta-analysis of the available cohort studies. METHODS Studies were searched through the PubMed, EMBASE, and Cochrane library databases. The following indexes were analyzed: rebleeding rate after negative BAE, rebleeding rate after different follow-up periods, the proportion of patients who underwent further evaluation after rebleeding, the percentage of patients with identified rebleeding sources, and the percentage of patients with rebleeding sources in the small intestine. Heterogeneity was assessed using the I(2) test. RESULTS Twelve studies that involved a total of 407 patients were included in the analysis. The pooled rebleeding rate after negative BAE for OGIB was 29.1% (95% CI: 17.2-42.6%). Heterogeneity was significant among the studies (I(2) = 88%; p < 0.0001). The Chi-squared test did not show a difference in rebleeding rates between the short and long follow-up period groups (p = 0.142). The pooled proportion of patients who underwent further evaluation after rebleeding was 86.1%. Among the patients who underwent further evaluation, rebleeding sources were identified in 73.6% of patients, and 68.8% of the identified rebleeding lesions were in the small intestine. CONCLUSION A negative result of BAE in patients with OGIB indicates a subsequently low risk of rebleeding. Further evaluation should be considered after rebleeding.
Clinical characteristics and treatment of terlipressin-induced ischemic skin necrosis: A synthesis of 35 literature reported cases
Journal of clinical pharmacy and therapeutics. 2022
WHAT IS KNOWN AND OBJECTIVE The clinical features of terlipressin-induced ischemic skin necrosis are unknown. The purpose of this study is to explore the clinical features of terlipressin-induced skin necrosis. METHODS We searched Chinese and English databases to collect case reports of terlipressin-induced skin necrosis for retrospective analysis. RESULTS AND DISCUSSION A total of 42 patients (31 males and 11 females) from 35 studies were included, with a median age of 54 years (range 0.17-84). The onset of skin ischemia ranged from a few hours to 21 days. The most common clinical manifestations were bulla (15 cases, 35.7%), cyanosis (12 cases, 28.6%), necrosis (11 cases, 26.2%), and purpura (10 cases, 23.8%). The following were often affected: the legs (26 cases), 61.9%), abdomen (13, 31.0%), scrotum (10 cases, 23.8%), feet (10 cases, 23.8%), upper extremities (8 cases, 19.0%), and hands (7 cases, 16.7%). Skin biopsy showed fibrin thrombus (7 cases, 38.9%), nonspecific inflammation (6 cases, 33.3%), and necrosis (10 cases, 55.6%). After discontinuation of terlipressin, skin symptoms improved in most patients. WHAT IS NEW AND CONCLUSION Ischemic skin necrosis is a rare and serious adverse effect of terlipressin. Patients receiving terlipressin therapy should be monitored closely for terlipressin-related ischemic complications. Terlipressin should be discontinued immediately if ischemic complications occur.
Comparison of Laparoscopic Sleeve Gastrectomy Bleeding and Leakage Rates in Four Staple-Line Reinforcement Methods: A Prospective Observational Study
Journal of laparoendoscopic & advanced surgical techniques. Part A. 2022
Introduction: Staple-line bleeding and gastric leakage are the most serious complications of laparoscopic sleeve gastrectomy (LSG). Reinforcement of the staple line is reported to be a method to reduce these complications rates, but the question of which method is preferable is a matter of controversy in the literature. In this study, we compared different staple-line reinforcement methods to assess their efficiency in preventing staple-line bleeding and leakage. Materials and Methods: Two hundred patients eligible for LSG were enrolled in the study and randomized into five groups based on the reinforcement method used during surgery: no reinforcement, oversewing using 3-0 polydioxanone (PDS) suture, oversewing using 4-0 barbed absorbable closure device (V-Lock), fibrin sealant glue, and buttress material. Intraoperative and postoperative complications were recorded and analyzed. Differences were considered statistically significant for P < .05. Results: The no-reinforcement group showed higher bleeding rates (20%), although only 2.5% of the patients required reintervention. All groups using staple-line reinforcement showed better outcomes in bleeding rates (P < .05). No statistically significant differences were observed among the groups in terms of the leakage rate, reintervention rate, intraoperative complications, and operative times. Conclusion: The reinforcement of the staple line decreased the bleeding rate in sleeve gastrectomy but did not affect the gastric leakage rate.
Preemptive Administration of Albumin during Pancreatectomy Does Not Reduce Postoperative Complications: A Prospective Randomized Controlled Trial
Journal of clinical medicine. 2022;11(3)
Despite the empirical use of human albumin during pancreatectomy to replace intraoperative volume loss while preventing fluid overload and edema, its impact on postoperative outcomes remains unclear. In addition, most previous studies have focused on the effects of therapeutic albumin usage. Here, we investigated whether preemptive administration of human albumin to prevent edema during pancreatectomy could reduce the incidence of moderate postoperative complications. Adult patients undergoing pancreatectomy were assigned to either the albumin group (n = 100) or the control group (n = 100). Regardless of the preoperative albumin level, 200 mL of 20% albumin was administered to the albumin group after induction of anesthesia. The primary outcome was the incidence of moderate postoperative complications as defined by a Clavien-Dindo classification grade ≥ 2 at discharge. Intraoperative net-fluid balance, a known risk factor of postoperative complication after pancreatectomy, was lower in the albumin group than in the control group (p = 0.030), but the incidence of moderate postoperative complications was not different between the albumin and control groups (47/100 vs. 38/100, respectively; risk ratio: 1.24, 95% CI: 0.89 to 1.71; p = 0.198). Therefore, preemptive administration of human albumin to prevent fluid overload and edema during pancreatectomy is not recommended because of its lack of apparent benefit in improving postoperative outcomes.
Timing of intraoperative crystalloid infusion may decrease total volume of infusate without affecting early graft function in live related renal transplant surgery: A randomized, surgeon-blinded clinical study
Indian journal of urology : IJU : journal of the Urological Society of India. 2022;38(1):53-61
INTRODUCTION Early graft function is crucial for successful kidney transplantation. Intravascular volume maintenance is paramount in ensuring reperfusion of transplanted kidney. This study was planned to compare whether the timing of fluid infusion can help to decrease amount of fluid given without altering early graft function during renal transplantation. MATERIALS AND METHODS The present study included forty recipients, randomized into standard (Group-S) or targeted fluid therapy (Group-T). Group S received fluid according to conventional fasting deficit while Group T received at 1 ml/kg/h from the start of surgery till start of vascular anastomosis after which fluid infusion rate in both group was increased to maintain a central venous pressure of 13-15 mm of Hg till reperfusion. Primary outcome measured was serum creatinine level on first postoperative day while secondary outcomes were IV fluid given, perioperative hemodynamics, onset of diuresis, graft turgidity, urine output, and renal function during first 6 postoperative days. RESULTS The study showed Group T postoperatively had early fall in serum creatinine (day 3) than S (day 6) although this difference was not statistically significant. Group T had received significantly less fluid per kg of dry weight (T-42.7 ± 9.7 ml/kg, S-61.1 ± 11.1 ml/kg, P < 0.001), had early diuresis, better graft turgidity and urine output than Group S. CONCLUSION Targeted hydration significantly decreases the total amount of fluid infused during the intraoperative period without altering early graft function. Targeted hydration during vascular anastomosis produced stable hemodynamics and early diuresis without any side-effects pertaining to hypo or hyper-volemia.Clinical trial identifier number-CTRI/2016/07/007111.
Efficacy and safety of ferric derisomaltose (FDI) compared with iron sucrose (IS) in patients with iron deficiency anemia after bariatric surgery
Obesity surgery. 2022
PURPOSE Iron deficiency is common following bariatric surgery, and treatment with intravenous iron is often required. This post hoc analysis of data from two randomized, open-label, multicenter trials evaluated the efficacy and safety of ferric derisomaltose (FDI; formerly iron isomaltoside 1000) versus iron sucrose (IS) over 4 weeks in adults with iron deficiency anemia (IDA) resulting from prior bariatric surgery. MATERIALS AND METHODS Data were pooled for participants who received FDI or IS in the PROVIDE or FERWON-IDA trials for the treatment of IDA post bariatric surgery. Efficacy outcomes included changes in hemoglobin (Hb) and iron parameters; safety outcomes included the incidence of adverse drug reactions (ADRs), serious or severe hypersensitivity reactions (HSRs), and hypophosphatemia. RESULTS The analysis included 159 patients. Mean (standard deviation) cumulative iron doses were 1199 (± 347) mg for FDI and 937 (± 209) mg for IS. Compared with IS, FDI resulted in a faster and more pronounced Hb response, and a higher proportion of responders (Hb level increase ≥ 2 g/dL from baseline) at all time points. The incidence of ADRs was similar with FDI and IS (15.1% and 18.2%, respectively), with no serious ADRs or serious or severe HSRs reported. The incidence of hypophosphatemia was low and similar in both treatment groups, with no cases of severe hypophosphatemia observed. CONCLUSIONS In patients with IDA resulting from bariatric surgery, FDI produced a faster and more pronounced Hb response than IS. Both FDI and IS were well tolerated.
Proton pump inhibitor treatment initiated prior to endoscopic diagnosis in upper gastrointestinal bleeding
The Cochrane database of systematic reviews. 2022;1:Cd005415
BACKGROUND Upper gastrointestinal (GI) bleeding is a common reason for emergency hospital admission. Proton pump inhibitors (PPIs) reduce gastric acid production and are used to manage upper GI bleeding. However, there is conflicting evidence regarding the clinical efficacy of proton pump inhibitors initiated before endoscopy in people with upper gastrointestinal bleeding. OBJECTIVES To assess the effects of PPI treatment initiated prior to endoscopy in people with acute upper GI bleeding. SEARCH METHODS We searched the CENTRAL, MEDLINE, Embase and CINAHL databases and major conference proceedings to October 2008, for the previous versions of this review, and in April 2018, October 2019, and 3 June 2021 for this update. We also contacted experts in the field and searched trial registries and references of trials for any additional trials. SELECTION CRITERIA We selected randomised controlled trials (RCTs) that compared treatment with a PPI (oral or intravenous) versus control treatment with either placebo, histamine-2 receptor antagonist (H(2)RA) or no treatment, prior to endoscopy in hospitalised people with uninvestigated upper GI bleeding. DATA COLLECTION AND ANALYSIS At least two review authors independently assessed study eligibility, extracted study data and assessed risk of bias. Outcomes assessed at 30 days were: mortality (our primary outcome), rebleeding, surgery, high-risk stigmata of recent haemorrhage (active bleeding, non-bleeding visible vessel or adherent clot) at index endoscopy, endoscopic haemostatic treatment at index endoscopy, time to discharge, blood transfusion requirements and adverse effects. We used standard methodological procedures expected by Cochrane. MAIN RESULTS We included six RCTs comprising 2223 participants. No new studies have been published after the literature search performed in 2008 for the previous version of this review. Of the included studies, we considered one to be at low risk of bias, two to be at unclear risk of bias, and three at high risk of bias. Our meta-analyses suggest that pre-endoscopic PPI use may not reduce mortality (OR 1.14, 95% CI 0.76 to 1.70; 5 studies; low-certainty evidence), and may reduce rebleeding (OR 0.81, 95% CI 0.62 to 1.06; 5 studies; low-certainty evidence). In addition, pre-endoscopic PPI use may not reduce the need for surgery (OR 0.91, 95% CI 0.65 to 1.26; 6 studies; low-certainty evidence), and may not reduce the proportion of participants with high-risk stigmata of recent haemorrhage at index endoscopy (OR 0.80, 95% CI 0.52 to 1.21; 4 studies; low-certainty evidence). Pre-endoscopic PPI use likely reduces the need for endoscopic haemostatic treatment at index endoscopy (OR 0.68, 95% CI 0.50 to 0.93; 3 studies; moderate-certainty evidence). There were insufficient data to determine the effect of pre-endoscopic PPI use on blood transfusions (2 studies; meta-analysis not possible; very low-certainty evidence) and time to discharge (1 study; very low-certainty evidence). There was no substantial heterogeneity amongst trials in any analysis. AUTHORS' CONCLUSIONS There is moderate-certainty evidence that PPI treatment initiated before endoscopy for upper GI bleeding likely reduces the requirement for endoscopic haemostatic treatment at index endoscopy. However, there is insufficient evidence to conclude whether pre-endoscopic PPI treatment increases, reduces or has no effect on other clinical outcomes, including mortality, rebleeding and need for surgery. Further well-designed RCTs that conform to current standards for endoscopic haemostatic treatment and appropriate co-interventions, and that ensure high-dose PPIs are only given to people who received endoscopic haemostatic treatment, regardless of initial randomisation, are warranted. However, as it may be unrealistic to achieve the optimal information size, pragmatic multicentre trials may provide valuable evidence on this topic.
Over-the-scope-clips versus standard treatment in high-risk patients with acute non-variceal upper gastrointestinal bleeding: a randomised controlled trial (STING-2)
OBJECTIVE Acute non-variceal upper gastrointestinal bleeding (NVUGIB) is managed by standard endoscopic combination therapy, but a few cases remain difficult and carry a high risk of persistent or recurrent bleeding. The aim of our study was to compare first-line over-the-scope-clips (OTSC) therapy with standard endoscopic treatment in these selected patients. DESIGN We conducted a prospective, randomised, controlled, multicentre study (NCT03331224). Patients with endoscopic evidence of acute NVUGIB and high risk of rebleeding (defined as complete Rockall Score ≥7) were included. Primary endpoint was clinical success defined as successful endoscopic haemostasis without evidence of recurrent bleeding. RESULTS 246 patients were screened and 100 patients were finally randomised (mean of 5 cases/centre and year; 70% male, 30% female, mean age 78 years; OTSC group n=48, standard group n=52). All but one case in the standard group were treated with conventional clips. Clinical success was 91.7% (n=44) in the OTSC group compared with 73.1% (n=38) in the ST group (p=0.019), with persistent bleeding occurring in 0 vs 6 in the OTSC versus standard group (p=0.027), all of the latter being successfully managed by rescue therapy with OTSC. Recurrent bleeding was observed in four patients (8.3%) in the OTSC group and in eight patients (15.4%) in the standard group (p=0.362). CONCLUSION OTSC therapy appears to be superior to standard treatment with clips when used by trained physicians for selected cases of primary therapy of NVUGIB with high risk of rebleeding. Further studies are necessary with regards to patient selection to identify subgroups benefiting most from OTSC haemostasis. TRIAL REGISTRATION NUMBER NCT03331224.
High-risk patients with acute non-variceal upper gastrointestinal bleeding enrolled in the STING-2 trial (n= 100).
First-line over-the-scope-clips therapy (OTSC group, n= 48).
Standard endoscopic treatment (ST group, n= 52).
Clinical success was 91.7% (44 patients) in the OTSC group compared with 73.1% (38 patients) in the ST group. Persistent bleeding occurred in 11.5% (6 patients) in the ST group, vs. zero patients in the OTSC group. Recurrent bleeding was observed in 8.3% (4 patients) in the OTSC group and in 15.4% (8 patients) in the ST group.