Peritoneal Damage in Laparoscopic Surgery

Peritoneal Damage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03020641
• Other study ID #: A-CGyD-2017
• Status: Completed
• Phase: N/A
• Start date: January 27, 2017
• Est. completion date: April 28, 2019

Study information

• Verified date: September 2021
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 28, 2019
• Est. primary completion date: April 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peritoneal Damage

Intervention

Procedure:
• Low pressure pneumoperitoneum
Low pressure pneumoperitoneum
• standard pneumoperitoneum pressure
standard pneumoperitoneum pressure

Locations

Country	Name	City	State
Spain	Ramon y Cajal Hospital	Madrid

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory Peritoneal Markers	logaritmic levels of mRNA of the different markers at time 1 hour after creation of the pneumoperitoneum	he values will be obtained from the study of peritoneal tissue samples one hour after the creation of the pneumoperitoneum (T1).
Primary	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.	The values will be obtained from the study of peritoneal tissue samples one hour after the creation of the pneumoperitoneum (T1).
Primary	Oxidative Stress Response Marker:MDA (Malondialdehyde)	MDA (malondialdehyde) determination will be done with ELISA	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)
Primary	Apoptotic Index	This measure is reported as the mean of the difference of the percentage of apoptotic cells at baseline minus the final	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.