Peritoneal Damage in Laparoscopic Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Peritoneal Damage
• Intervention / Treatment: Procedure: Low pressure pneumoperitoneum; Procedure: standard pneumoperitoneum pressure

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Ramón y Cajal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low pneumoperitoneum pressure.; Pneumoperitoneum pressure at 8 mmHg or lower.	Procedure: Low pressure pneumoperitoneum; Low pressure pneumoperitoneum
Active Comparator: standard pneumoperitoneum pressure; Pneumoperitoneum pressure at 12 mmHG or higher	Procedure: standard pneumoperitoneum pressure; standard pneumoperitoneum pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).
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)
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.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 27, 2017
• Primary Completion (Actual): April 28, 2019
• Study Completion (Actual): April 28, 2019

Study Registration Dates

• First Submitted: January 9, 2017
• First Submitted That Met QC Criteria: January 11, 2017
• First Posted (Estimate): January 13, 2017

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 21, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: low pressure pneumoperitoneum; standard pressure pneumoperitoneum; laparoscopy cholecystectomy
• Other Study ID Numbers: A-CGyD-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No