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.
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.
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.
A predictive model for blood transfusion during liver resection
European journal of surgical oncology : the journal of the European Society of Surgical Oncology and the British Association of Surgical Oncology. 2022
BACKGROUND A predictive model that can identify patients who are at increased risk of intraoperative blood transfusion could guide preoperative transfusion risk counseling, optimize health care resources, and reduce medical costs. Although previous studies have identified some predictors for particular populations, there is currently no existing model that uses preoperative variables to accurately predict blood transfusion during surgery, which could help anesthesiologists optimize intraoperative anesthetic management. METHODS We collected data from 582 patients who underwent elective liver resection at a university-affiliated tertiary hospital between January 1, 2018, and December 31, 2020. The data set was then randomly divided into a training set (n = 410) and a validation set (n = 172) at a 7:3 ratio. The least absolute shrinkage and selection operating regression model was used to select the optimal feature, and multivariate logistic regression analysis was applied to construct the transfusion risk model. The concordance index (C-index) and the area under the receiver operating characteristic (ROC) curve (AUC) were used to evaluate the discrimination ability, and the calibration ability was assessed with calibration curves. In addition, we used decision curve analysis (DCA) to estimate the clinical application value. For external validation, the test set data were employed. RESULTS The final model had 8 predictor variables for intraoperative blood transfusion, which included the following: preoperative hemoglobin level, preoperative prothrombin time >14 s, preoperative total bilirubin >21 μmol/L, respiratory diseases, cirrhosis, maximum lesion diameter >5 cm, macrovascular invasion, and previous abdominal surgery. The model showed a C-index of 0.834 (95% confidence interval, 0.789-0.879) for the training set and 0.831 (95% confidence interval, 0.766-0.896) for the validation set. The AUCs were 0.834 and 0.831 for the training and validation sets, respectively. The calibration curve showed that our model had good consistency between the predictions and observations. The DCA demonstrated that the transfusion nomogram was reliable for clinical applications when an intervention was decided at the possible threshold across 1%-99% for the training set. CONCLUSION We developed a predictive model with excellent accuracy and discrimination ability that can help identify those patients at higher odds of intraoperative blood transfusion. This tool may help guide preoperative counseling regarding transfusion risk, optimize health care resources, reduce medical costs, and optimize anesthetic management during surgery.
Effect of prophylactic endoscopic clipping for prevention of delayed bleeding after endoscopic papillectomy for ampullary neoplasm: a multicenter randomized trial
BACKGROUND : Endoscopic clip placement is technically challenging using a duodenoscope, limiting their application for treatment of bleeding after endoscopic papillectomy. This study evaluated the efficacy of newly designed clips to prevent bleeding after endoscopic papillectomy. METHODS : Patients (n = 80) with suspected benign adenomas on the major papilla who were scheduled for endoscopic papillectomy with or without clipping were randomized. A new duodenoscope-compatible clip capable of being rotated, reopened, and repeatedly repositioned was used. The primary end point was incidence of delayed bleeding. RESULTS : The clipping procedure was successful in all patients. The incidence of delayed bleeding was nonsignificantly higher in the no-clipping group than in the clipping group (31.6 % [95 % confidence interval (CI) 19.1-47.5] vs. 15.0 % [95 %CI 7.1-29.1]). The incidence of post-endoscopic retrograde cholangiopancreatography pancreatitis did not differ significantly between the groups (clipping vs. no-clipping: 17.5 % [95 %CI 8.7-31.9] vs. 5.3 % [95 %CI 1.5-17.3]), and all cases were mild. CONCLUSIONS : Placement of the newly designed rotatable clip was technically feasible and tended to have a protective effect by preventing delayed bleeding after endoscopic papillectomy, although statistical significance was not reached.
Scheduled second look endoscopy after endoscopic hemostasis to patients with high risk bleeding peptic ulcers: a Randomized Controlled Trial
Surgical endoscopy. 2022
BACKGROUND The recommendation of second look endoscopy (SLOGD) in selected patients at high risk for rebleeding has been inconclusive. This study aimed to evaluate the benefit of SLOGD in selected patients predicted at high risk of recurrent bleeding. METHODS From a cohort of 939 patients with bleeding peptic ulcers who underwent endoscopic hemostasis, we derived a 9-point risk score (age > 60, Male, ulcer ≥ 2 cm in size, posterior bulbar or lesser curve gastric ulcer, Forrest I bleeding, haemoglobin < 8 g/dl) to predict recurrent bleeding. We then validated the score in another cohort of 1334 patients (AUROC 0.77). To test the hypothesis that SLOGD in high-risk patients would improve outcomes, we did a randomized controlled trial to compare scheduled SLOGD with observation alone in those predicted at high risk of rebleeding (a score of ≥ 5). The primary outcome was clinical bleeding within 30 days of the index bleed. RESULTS Of 314 required, we enrolled 157 (50%) patients (SLOGD n = 78, observation n = 79). Nine (11.8%) in SLOGD group and 14 (18.2%) in observation group reached primary outcome (absolute difference 6.4%, 95% CI - 5.0% to 17.8%). Twenty-one of 69 (30.4%) patients who underwent SLOGD needed further endoscopic treatment. No surgery for bleeding control was needed. There were 6 vs. 3 of 30-day deaths in either group (p = 0.285, log rank). No difference was observed regarding blood transfusion and hospitalization. CONCLUSIONS In this aborted trial that enrolled patients with bleeding peptic ulcers at high-risk of recurrent bleeding, scheduled SLOGD did not significantly improve outcomes. ClinicalTrials.gov:NCT02352155.
The clinical effect of emergency gastroscopy on upper gastrointestinal hemorrhage patients
American journal of translational research. 2021;13(4):3501-3507
OBJECTIVE To assess the clinical effects of emergency gastroscopies on acute upper gastrointestinal hemorrhage patients. METHODS 212 patients with acute upper gastrointestinal hemorrhages were randomly divided into an experimental group (n=106) and a control group (n=106). The experimental group underwent emergency gastroscopies, and the control group underwent the traditional treatment. We measured the hemostasis effects, the treatment indexes, and the incidences of adverse reactions to assess the clinical effects. At the same time, we recorded the hemoglobin levels, the rebleeding rates, and the mortality rate to assess the hemostasis effect. RESULTS The hemostasis effect (the total hemostasis effective rate), the treatment index (the hemostasis time, stool occult blood turning negative time, bowel sound recovery time, and the blood transfusion volumes), the hemoglobin levels, the rebleeding rates, and the mortality were better in the EG than they were in the CG (P<0.05). CONCLUSIONS Emergency gastroscopy is an effective treatment for acute upper gastrointestinal hemorrhage patients, because it improves the hemostasis effective rate and the survival rate. Clinical therapy effectively cures the hemorrhages in patients with acute upper gastrointestinal hemorrhages.