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BiClamp® forcep liver transection versus clamp crushing technique for liver resection: study protocol for a randomized controlled trial.

ABSTRACT: Blood loss and the requirement of blood transfusions during liver transection have been shown to correlate well with higher morbidity and mortality rates and a worse prognosis. Various devices for liver parenchymal transection have been developed to reduce intraoperative blood loss. The goal of this study is to evaluate the safety and effectiveness of BiClamp® forcep transection compared to a clamp crushing technique in patients undergoing liver resection.This study will include patients 18 years and older scheduled for hepatectomy with hepatic vascular exclusion who give informed consent. A sample size of 48 patients in each randomization arm will be calculated to detect a difference in the reduction of blood loss of approximately 200 ml (90% power and ??=?0.05 (two-tailed)). The primary efficacy endpoint of the trial will be the total intraoperative blood loss based on the randomized dissection technique. The statistical analysis is based on the intention-to-treat population. Patients will be followed up on for three months for complications and adverse events.This prospective, single-center, randomized controlled, single-blinded, two-group parallel trial is designed to assess the efficacy and safety of BiClamp forcep hepatectomy versus clamp crushing for parenchymal transection during elective hepatic resection.This trial was registered with Clinicaltrials.gov (identifier: NCT02197481 ) on 15 July 2014.

SUBMITTER: Chen JM

PROVIDER: S-EPMC4434524 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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BiClamp® forcep liver transection versus clamp crushing technique for liver resection: study protocol for a randomized controlled trial.

Chen Jiang-ming JM Geng Wei W Liu Fu-bao FB Zhao Hong-chuan HC Xie Sheng-xue SX Hou Hui H Zhao Yi-jun YJ Wang Guo-bin GB Geng Xiao-ping XP

Trials 20150430

<h4>Background</h4>Blood loss and the requirement of blood transfusions during liver transection have been shown to correlate well with higher morbidity and mortality rates and a worse prognosis. Various devices for liver parenchymal transection have been developed to reduce intraoperative blood loss. The goal of this study is to evaluate the safety and effectiveness of BiClamp® forcep transection compared to a clamp crushing technique in patients undergoing liver resection.<h4>Methods/design</h ...[more]

PMID: 25925431

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Project description:BackgroundGas embolism induced by CO2 pneumoperitoneum is commonly identified as a risk factor for morbidity, especially cardiopulmonary morbidity, after laparoscopic liver resection (LLR) in adults. Increasing pneumoperitoneum pressure (PP) contributes to gas accumulation following laparoscopy. However, few studies have examined the effects of PP in the context of LLR. In LLR, the PP-central venous pressure (CVP) gradient is increased due to hepatic vein rupture, hepatic sinusoid exposure, and low CVP management, which together increase the risk of CO2 embolization. The aim of this study is to primarily determine the role of low PP (10 mmHg) on the incidence of severe gas embolism.MethodsAdult participants (n = 140) undergoing elective LLR will be allocated to either a standard (15 mmHg) or low (10 mmHg) PP group. Anesthesia management, postoperative care, and other processes will be performed similarly in both groups. The occurrence of severe gas embolism, which is defined as gas embolism ≥ grade 3 according to the Schmandra microbubble method, will be detected by transesophageal echocardiography (TEE) and recorded as the primary outcome. The subjects will be followed up until discharge and followed up by telephone 1 and 3 months after surgery. Postoperative outcomes, such as the Post-Operative Quality of Recovery Scale, pain severity, and adverse events, will be assessed. Serum cardiac markers and inflammatory factors will also be assessed during the study period. The correlation between intraoperative inferior vena cava-collapsibility index (IVC-CI) under TEE and central venous pressure (CVP) will also be explored.DiscussionThis study is the first prospective randomized clinical trial to determine the effect of low versus standard PP on gas embolism using TEE during elective LLR. These findings will provide scientific and clinical evidence of the role of PP.Trial statusProtocol version: version 1 of 21-08-2020 TRIAL REGISTRATION: ChiCTR2000036396 ( http://www.chictr.org.cn ). Registered on 22 August 2020.

Project description:BackgroundAs an emerging technology, robot-assisted surgical system has some potential merits in many complicated endoscopic procedures compared with laparoscopic surgery. But robot-assisted liver resection is still a controversial problem on its advantages compared with laparoscopic liver resection. We aimed to perform the meta-analysis to assess and compare the clinical outcomes of robot-assisted and laparoscopic liver resection.MethodsWe searched PubMed, Cochrane Library, Embase databases, Clinicaltrials, and Opengrey through March 24, 2020, including references of qualifying articles. English-language, original investigations in humans about robot-assisted and laparoscopic hepatectomy were included. Titles, abstracts, and articles were reviewed by at least 2 independent readers. Continuous and dichotomous variables were compared by the weighted mean difference (WMD) and odds ratio (OR), respectively.ResultsOf 936 titles identified in our original search, 28 articles met our criteria, involving 3544 patients. Compared with laparoscopy, the robot-assisted groups had longer operative time (WMD: 36.93; 95% CI, 19.74-54.12; P < 0.001), lower conversion rate (OR: 0.63; 95% CI, 0.46-0.87; P = 0.005), higher transfusion rate (WMD: 2.39; 95% CI, 1.51-3.76; P < 0.001) and higher total cost (WMD:0.49; 95% CI, 0.42-0.55; P < 0.001). In addition, the baseline characteristics of patients about largest tumor size was larger (WMD: 0.36; 95% CI, 0.16-0.56; P < 0.001) and malignant lesions rate was higher (WMD: 1.50; 95% CI, 1.21-1.86; P < 0.001) in the robot-assisted versus laparoscopic hepatectomy. The subgroup analysis of minor hepatectomy showed robot-assisted was associated with longer operative time (WMD: 36.00; 95% CI, 12.59-59.41; P = 0.003), longer length of stay (WMD: 0.51; 95% CI, 0.02-1.01; p = 0.04) and higher total cost (WMD: 0.48; 95% CI, 0.25-0.72; P < 0.001) (Table 3); while the subgroup analysis of major hepatectomy showed robot-assisted was associated with lower estimated blood loss (WMD: -122.43; 95% CI, -151.78--93.08; P < 0.001).ConclusionsOur meta-analysis revealed that robot-assisted was associated with longer operative time, lower conversion rate, higher transfusion rate and total cost, and robot-assisted has certain advantages in major hepatectomy compared with laparoscopic hepatectomy.

Dataset Information

BiClamp® forcep liver transection versus clamp crushing technique for liver resection: study protocol for a randomized controlled trial.

Publications

BiClamp® forcep liver transection versus clamp crushing technique for liver resection: study protocol for a randomized controlled trial.

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