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临床试验/NCT03020641
NCT03020641已完成不适用

Characterization of Changes in Peritoneal Cells Gene Expression After Standard Versus Low Pressure Laparoscopic Cholecystectomy and Its Clinical Correlation

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年1月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Inflammatory Peritoneal Markers

研究概览

简要总结

The investigators hypothesized that applying a low intraperitoneal pressure pneumoperitoneum (≤ 8mmHg) during laparoscopic cholecystectomy, the adverse impact on the surgical peritoneal environment (measured as gene expression of extracellular matrix, adhesion and inflammatory cytokine as well as oxidative stress response and apoptotic index), can be minimized and probably clinical outcomes might be better.

详细描述

Cholelithiasis is one of the most frequent abdominal diseases requiring surgical treatment. Laparoscopic cholecystectomy is currently the procedure of choice to remove the gallbladder. There is growing evidence that increased intra-abdominal pressure pneumoperitoneum, even for short periods of time, is associated with both transient and sometimes persistent adverse effects that might negatively affect the surgical peritoneal environment .There are some studies that have demonstrated that using low intraperitoneal pressure pneumoperitoneum, undesired effects like adverse impact on peritoneal tissue and negative clinical outcomes could be reduced.Therefore intraperitoneal pressure target during laparoscopy should be the lowest to allow surgery be securely performed. Many strategies have been tested in order to improve the volume of gas can be insufflated inside the abdominal cavity while maintaining low pneumoperitoneum pressure during laparoscopy.So far the most studied strategy has been deep neuromuscular blockade.However the effect of the depth of neuromuscular blockade in the intraabdominal volume is still controversial as sometimes in humans its benefits are marginal.There is scarce information in the medical literature regarding the adverse impact on peritoneal tissue of high pneumoperitoneum pressure during laparoscopy in humans. In addition available data are provided by non-prospective, non-randomized and small sample studies, so randomized controlled trials are required to ascertain this issues.To our knowledge our study is the first prospective and randomized controlled trial in humans aiming to study the adverse impact of high pressure pneumoperitoneum on peritoneal tissue as well as to associate it with clinical outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients older than 18 years, signed informed consent, undergoing laparoscopic cholecystectomy for symptomatic cholelithiasis or gallbladder polyps.

排除标准

  • Emergency surgery.
  • Previous surgery at supramesocolic compartment.
  • Previous peritoneal inflammatory process.
  • Pregnancy or breastfeeding.
  • Patient refusal to participate in the study

结局指标

主要结局

Inflammatory Peritoneal Markers

时间窗: he values will be obtained from the study of peritoneal tissue samples one hour after the creation of the pneumoperitoneum (T1).

logaritmic levels of mRNA of the different markers at time 1 hour after creation of the pneumoperitoneum

Remodeling Peritoneal Markers :( Gene Expression (mRNA) Levels of)

时间窗: The values will be obtained from the study of peritoneal tissue samples one hour after the creation of the pneumoperitoneum (T1).

f. CTGF "connective tissue growth factor". g. MMP-9 "matrix metalloproteinase-9". h. PAI-I "plasminogen activator inhibitor-I". i. E-selectin. Samples will be processed to obtain total RNA with TRI Reagent™ (Sigma) and will be quantified with NanoDrop spectrophotometer.

Oxidative Stress Response Marker:MDA (Malondialdehyde)

时间窗: The values of the main variables will be obtained from the study of peritoneal tissue samples one hour after the creation of the pneumoperitoneum (T1)

MDA (malondialdehyde) determination will be done with ELISA

Apoptotic Index

时间窗: The values of the main variables will be obtained from the study of peritoneal tissue samples, one hour after the creation of the pneumoperitoneum compared to basal peritoneal tissue samples.

This measure is reported as the mean of the difference of the percentage of apoptotic cells at baseline minus the final

次要结局

未报告次要终点

研究者

研究点 (2)

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