介质固定方法 (MEFIX) 与预防彼得森发生的常规方法之间的比较:多中心随机对照试验的研究方案
Jae Kyun Park1, Dae Hwan Kim1, Tae-Yong Jeon1
1Department of Surgery, Pusan National University Hospital, Pusan National University School of Medicine, Biomedical Institution, Busan, 49241, Republic of Korea.
Trials
|January 3, 2024
概括
这项研究将中肠固定 (MEFIX) 方法与胃外科手术后关闭彼得森缺陷的常规技术进行比较. 预计MEFIX将是一个更快,更简单的关闭方法,而不会增加并发症.
科学领域:
- 胃肠道手术 胃肠道手术
- 手术瘤学手术瘤学
- 微创手术是最少的侵入性手术.
背景情况:
- 佩特森是Billroth-II (B-II) 或Roux-en-Y (REY) 解剖形成后的一个并发症.
- 缺陷封闭是预防彼得森的关键策略.
- 腹腔镜或机器人胃切除术增加了内部的风险.
研究的目的:
- 为了比较由彼得森带引起的严重肠道阻塞 (Clavien-Dindo III级) 的发生率.
- 为了评估中介管固定 (MEFIX) 方法与传统关闭技术的有效性.
- 评估与不同的彼得森缺陷封闭方法相关的术后并发症.
主要方法:
- 未来的,单盲,非劣势随机对照多中心试验.
- 包括胃癌患者 (I-III阶段) 在腹腔镜或机器人胃切除术后接受B-II或REY解剖.
- 随机分配到传统的彼得森缺陷封闭或MEFIX方法.
主要成果:
- 主要终点:在3年内需要为彼得森脏相关肠道阻塞进行手术的患者数量.
- 评估手术部位感染,腹腔内液体收集和其他并发症的二次终点.
- 数据分析以确定MEFIX方法的非劣势性.
结论:
- 预计MEFIX方法将证明与传统封闭相比,它在预防严重肠道阻塞方面没有劣势.
- 这种方法旨在更快,更简单地解决彼得森缺陷.
- 该研究预计MEFIX技术不会增加术后并发症.
相关概念视频
Regression Toward the Mean
Regression toward the mean (“RTM”) is a phenomenon in which extremely high or low values—for example, and individual’s blood pressure at a particular moment—appear closer to a group’s average upon remeasuring. Although this statistical peculiarity is the result of random error and chance, it has been problematic across various medical, scientific, financial and psychological applications. In particular, RTM, if not taken into account, can interfere when researchers try to extrapolate results...
What is an Experiment?
An experiment is a planned activity carried out under controlled conditions. The purpose of an experiment is to investigate the relationship between two variables. When one variable causes change in another, we call the first variable the explanatory or independent variable. The affected variable is called the response or dependent variable. In a randomized experiment, the researcher manipulates values of the explanatory variable and measures the resulting changes in the response variable. The...
Randomized Experiments
The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
Simple...
Simple randomization
Simple...
Strategies for Assessing and Addressing Confounding
Confounding is a critical issue in epidemiological studies, often leading to misleading conclusions about associations between exposures and outcomes. It occurs when the relationship between the exposure and the outcome is mixed with the effects of other factors that influence the outcome. Given that, addressing confounding is of high importance for drawing accurate inferences in research.
Confounding can be addressed at both the design phase of a study and through analytical methods after data...
Confounding can be addressed at both the design phase of a study and through analytical methods after data...
Kaplan-Meier Approach
The Kaplan-Meier estimator is a non-parametric method used to estimate the survival function from time-to-event data. In medical research, it is frequently employed to measure the proportion of patients surviving for a certain period after treatment. This estimator is fundamental in analyzing time-to-event data, making it indispensable in clinical trials, epidemiological studies, and reliability engineering. By estimating survival probabilities, researchers can evaluate treatment effectiveness,...
McNemar's Test
McNemar's Test is a nonparametric statistical test used to determine if there is a significant difference in proportions between two related groups when the outcome is binary (e.g., yes/no, success/failure). It is beneficial when we have paired data, such as pre-test/post-test designs, where the same subjects are measured under two different conditions. The test is named after the statistician Quinn McNemar, who introduced it in 1947. It is commonly used in situations where subjects are...


