Peritoneal Damage in Laparoscopic Surgery

Not Applicable

Completed

Conditions: Peritoneal Damage

Interventions: Procedure: standard pneumoperitoneum pressure
Procedure: Low pressure pneumoperitoneum

Registration Number: NCT03020641

Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 100

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard pneumoperitoneum pressure	standard pneumoperitoneum pressure	Pneumoperitoneum pressure at 12 mmHG or higher
Low pneumoperitoneum pressure.	Low pressure pneumoperitoneum	Pneumoperitoneum pressure at 8 mmHg or lower.

Primary Outcome Measures

Name	Time	Method
Inflammatory Peritoneal Markers	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)	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)	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	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