Dataset Information

Randomized controlled trial to investigate the impact of anticoagulation on the incidence of splenic or portal vein thrombosis after laparoscopic splenectomy.

ABSTRACT: Splenic and portal vein thrombosis (SPVT) is a potentially life-threatening complication of splenectomy. There is a paucity of studies examining the role of prophylactic pre- and postoperative anticoagulation in the prevention of this complication. We designed a prospective randomized controlled trial (RCT) to more rigorously address the impact of prophylactic anticoagulation on the incidence of asymptomatic or symptomatic SPVT, detected on Doppler ultrasound, after laparoscopic splenectomy.This 2-centre, phase II, prospective, open-label, parallel-assignment RCT compared no postoperative anticoagulation to a regimen of 40 mg of enoxaparin subcutaneously once daily for 21 days. All patients underwent Doppler ultrasonography of the splenoportal system preoperatively and again 14-28 days after surgery to screen for nonocclusive or occlusive thrombosis.From November 2006 to November 2008, 35 patients were enrolled in the RCT. Four patients withdrew, 1 required conversion to an open procedure and 1 died at 3 months (the cause of death was not related to the study). Of the 29 patients remaining, 15 were randomly assigned to the anticoagulation group and 14 to the nonanticoagulation group. One (3.4%) patient in the treatment group experienced portal thrombosis. Rates of postoperative bleeding were similar in both groups.This RCT of anticoagulation found a low overall risk of SPVT after laparoscopic splenectomy; however, this is an underpowered study, and further multicentred clinical trials are needed.

SUBMITTER: Wang H

PROVIDER: S-EPMC3191895 | biostudies-literature | 2011 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Randomized controlled trial to investigate the impact of anticoagulation on the incidence of splenic or portal vein thrombosis after laparoscopic splenectomy.

Wang Haili H Kopac Daniel D Brisebois Ronald R Sample Clifford C Shapiro A M James AM

Canadian journal of surgery. Journal canadien de chirurgie 20110801 4

<h4>Background</h4>Splenic and portal vein thrombosis (SPVT) is a potentially life-threatening complication of splenectomy. There is a paucity of studies examining the role of prophylactic pre- and postoperative anticoagulation in the prevention of this complication. We designed a prospective randomized controlled trial (RCT) to more rigorously address the impact of prophylactic anticoagulation on the incidence of asymptomatic or symptomatic SPVT, detected on Doppler ultrasound, after laparoscop ...[more]

PMID: 21443837

Similar Datasets

Project description:ObjectiveSplenectomy is one crucial solution for hypersplenism with portal hypertension. However, portal vein system thrombosis (PVST) caused by hemodynamic changes affects the prognosis of patients. We analyze the changes in portal vein hemodynamics following splenectomy for Wilson's disease combined with portal hypertension and the influencing factors that lead to PVST.MethodsA retrospective cohort study was conducted, in which 237 Wilson's disease patients with hypersplenism underwent splenectomy. The hemodynamic indices of the portal vein were monitored before surgery and on the 1st, 7th, and 14th days around surgery. The patients were divided into PVST and non-PVST groups. The clinical factors were identified by univariate and multivariate logistic regression. The Logit P was calculated according to the logistic regression prediction model, and the ROC curve for each independent factor was plotted.ResultsThe portal vein velocity, flow, and inner diameter showed a downward trend around surgery, with statistically significant differences between each time point (P < 0.01). The PVST incidence rate was 55.7%. Univariate analysis revealed that the platelet (PLT) levels on the postoperative 3rd and 7th days (P = 0.001; P < 0.001), D-dimer (D-D) on the postoperative 7th and 14th days (P = 0.002; P < 0.001), preoperative portal vein velocity, flow, diameter (P < 0.001), and splenic vein diameter (P < 0.001) were all statistically and significantly different between the two groups. Multivariate logistic regression revealed a significant increase in PLT on the postoperative 7th day (OR = 1.043, 95% CI, 1.027-1.060, P < 0.001) and D-D on the postoperative 14th day (OR = 1.846, 95% CI, 1.400-2.435, P < 0.001). Preoperative portal and splenic vein diameters (OR = 1.565, 95% CI, 1.213-2.019, P = 0.001; OR = 1.671, 95% CI, 1.305-2.140, P < 0.001) were the risk factors for PVST. However, preoperative portal vein velocity and flow (OR = 0.578, 95% CI, 0.409-0.818, P = 0.002; OR = 0.987, 95% CI, 0.975-0.990, P = 0.046) were protective factors for PVST. Logit P was calculated using a logistic regression prediction model with a cut-off value of -0.32 and an area under receiver operating characteristic curve of 0.952 with 88.61% accuracy.ConclusionsSplenectomy relieves portal hypertension by reducing the hemodynamics index. PVST is linked to multiple factors, including preoperative portal vein diameter, velocity, flow, and splenic vein diameter, especially PLT on the postoperative 7th day and D-D on the postoperative 14th day. The predictive model is accurate in predicting PVST.

Project description:ObjectiveSplenectomy is a vital treatment method for hypersplenism with portal hypertension. However, portal venous system thrombosis (PVST) is a serious problem after splenectomy. Therefore, constructing an effective visual risk prediction model is important for preventing, diagnosing, and treating early PVST in hepatolenticular degeneration (HLD) surgical patients.MethodsBetween January 2016 and December 2021, 309 HLD patients were selected. The data were split into a development set (215 cases from January 2016 to December 2019) and a validation set (94 cases from January 2019 to December 2021). Patients' clinical characteristics and laboratory examinations were obtained from electronic medical record system, and PVST was diagnosed using Doppler ultrasound. Univariate and multivariate logistic regression analyses were used to establish the prediction model by variables filtered by LASSO regression, and a nomogram was drawn. The area under the curve (AUC) of receiver operating characteristic (ROC) curve and Hosmer-Lemeshow goodness-of-fit test were used to evaluate the differentiation and calibration of the model. Clinical net benefit was evaluated by using decision curve analysis (DCA). The 36-month survival of PVST was studied as well.ResultsSeven predictive variables were screened out using LASSO regression analysis, including grade, POD14D-dimer (Postoperative day 14 D-dimer), POD7PLT (Postoperative day 7 platelet), PVD (portal vein diameter), PVV (portal vein velocity), PVF (portal vein flow), and SVD (splenic vein diameter). Multivariate logistic regression analysis revealed that all seven predictive variables had predictive values (P < 0.05). According to the prediction variables, the diagnosis model and predictive nomogram of PVST cases were constructed. The AUC under the ROC curve obtained from the prediction model was 0.812 (95% CI: 0.756-0.869) in the development set and 0.839 (95% CI: 0.756-0.921) in the validation set. Hosmer-Lemeshow goodness-of-fit test fitted well (P = 0.858 for development set; P = 0.137 for validation set). The nomogram model was found to be clinically useful by DCA. The 36-month survival rate of three sites of PVST was significantly different from that of one (P = 0.047) and two sites (P = 0.023).ConclusionThe proposed nomogram-based prediction model can predict postoperative PVST. Meanwhile, an earlier intervention should be performed on three sites of PVST.

Dataset Information

Randomized controlled trial to investigate the impact of anticoagulation on the incidence of splenic or portal vein thrombosis after laparoscopic splenectomy.

Publications

Randomized controlled trial to investigate the impact of anticoagulation on the incidence of splenic or portal vein thrombosis after laparoscopic splenectomy.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets