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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
100
Low pressure pneumoperitoneum
standard pneumoperitoneum pressure
Ramon y Cajal Hospital
Madrid, Spain
Inflammatory Peritoneal Markers
logaritmic levels of mRNA of the different markers at time 1 hour after creation of the pneumoperitoneum
Time frame: he values will be obtained from the study of peritoneal tissue samples one hour after the creation of the pneumoperitoneum (T1).
Remodeling Peritoneal Markers :( Gene Expression (mRNA) Levels of)
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.
Time frame: The values will be obtained from the study of peritoneal tissue samples one hour after the creation of the pneumoperitoneum (T1).
Oxidative Stress Response Marker:MDA (Malondialdehyde)
MDA (malondialdehyde) determination will be done with ELISA
Time frame: 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)
Apoptotic Index
This measure is reported as the mean of the difference of the percentage of apoptotic cells at baseline minus the final
Time frame: 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.
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