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The Effect of Intrabdominal Pressure in Patients Undergoing Bariatric Surgery

2021年6月16日 更新者:Meliha Orhon、Marmara University

The Effect of Intrabdominal Pressure on Postoperative Mortality and Morbidity in Patients Undergoing Bariatric Surgery

Morbid obesity is a global health problem that concerns the whole world. It is associated with many concomitant health problems such as diabetes, hypertension, congestive heart failure. There are publications showing that morbid obesity increases chronic intra-abdominal pressure, and it has been investigated that this chronic pressure exposure may cause many comorbidities accompanying obesity. When we reviewed the literature, we could not find an adequate study showing the effects of obesity-related increased intra-abdominal pressure on postoperative mortality and morbidity.

The aim of this study is to show the effect of obesity-related intra-abdominal pressure on postoperative mortality and morbidity.

研究概览

详细说明

Our study included 80 female patients with ASA (American Society of Anesthesia) II-III, who were planned to undergo laparoscopic sleeve gasterctomy or bypass operation after ethics committee approval. BMI (body Mass Index)> 35, 18-65 years old, female, non-smoker, not undergoing revisional bariatric surgery, and not undergoing major abdominal surgery before were included. Propofol 2mg/kg, Remifentanil 1mcg/kg, and rocuronium 0.6mg/kg were administered to the patients by monitoring with ECG, pulse oximetry and non-invasive blood pressure measurement, which we performed in bariatric surgery patients in our clinic. The corrected weights of the patients were used in dose calculations as recommended by the Society of Bariatric Anesthesia. Immediately after intubation, while the patient was lying in the supine position, intra-abdominal measurement was taken from the bladder catheter and recorded. Then, after the surgical site antisepsis, when the trocar required for the operation was placed by the general surgeon, another measurement was made from the trocar port. The measurements were recorded. Arterial blood pressure, heart rate, oxygen saturation, maintenance fluids, and complications were recorded every 5 minutes intraoperatively. Postoperative hospital stay of the patients, urine output, onset time of bowel movements, and all complications were recorded.

SPSS 21.0 computer program was used for statistical analysis. The normality of the distribution of the data was evaluated with the Kolmogorov-Smirnov test. Intergroup data will be evaluated by one-way ANOVA, and in-group data will be evaluated with repetitive ANOVA test. Chi-square was used in the analysis of ordinal data. P < 0.05 will be considered as a statistically significant difference. The sample size was calculated as 80 patients at 90% confidence interval.

研究类型

观察性的

注册 (实际的)

65

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Maltepe
      • Istanbul、Maltepe、火鸡、34854
        • Marmara University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 60年 (成人)

接受健康志愿者

有资格学习的性别

女性

取样方法

概率样本

研究人群

ASA (American Society of Anesthesia) II-III female patient who is planned to undergo laparoscopic sleeve gasterctomy or bypass operation will be included. BMI (body Mass Index)> 35, 18-60 years old, female, non-smoker

描述

Inclusion Criteria:

  • ASA (American Society of Anesthesia) II-III female patient who is planned to undergo laparoscopic sleeve gasterctomy or bypass operation will be included. BMI (body Mass Index)> 35, 18-60 years old, female, non-smoker, not undergoing revisional bariatric surgery, and not undergoing major abdominal surgery before were included

Exclusion Criteria:

  • Patients with severe cardiac and respiratory distress, liver and kidney failure, and those who did not consent to the study will not be accepted into the study.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:仅案例
  • 时间观点:预期

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
the effect of obesity-related intra-abdominal pressure
大体时间:during procedure
measure intra-abdominal pressure from the trochar site
during procedure

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年1月5日

初级完成 (实际的)

2020年6月5日

研究完成 (实际的)

2021年5月5日

研究注册日期

首次提交

2021年6月4日

首先提交符合 QC 标准的

2021年6月16日

首次发布 (实际的)

2021年6月18日

研究记录更新

最后更新发布 (实际的)

2021年6月18日

上次提交的符合 QC 标准的更新

2021年6月16日

最后验证

2021年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 09.2020.133

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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