Peritoneal Damage in Laparoscopic Surgery

NCT ID: NCT03020641

Last Updated: 2021-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-27
• Study Completion Date: 2019-04-28

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.

Conditions

Peritoneal Damage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Low pneumoperitoneum pressure.

Pneumoperitoneum pressure at 8 mmHg or lower.

Group Type: EXPERIMENTAL

Low pressure pneumoperitoneum

Intervention Type: PROCEDURE

Low pressure pneumoperitoneum

standard pneumoperitoneum pressure

Pneumoperitoneum pressure at 12 mmHG or higher

Group Type: ACTIVE_COMPARATOR

standard pneumoperitoneum pressure

Intervention Type: PROCEDURE

standard pneumoperitoneum pressure

Interventions

Low pressure pneumoperitoneum

Low pressure pneumoperitoneum

Intervention Type: PROCEDURE

standard pneumoperitoneum pressure

standard pneumoperitoneum pressure

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ramon y Cajal Hospital

Madrid, , Spain

Countries

Spain

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

A-CGyD-2017

Identifier Type: -

Identifier Source: org_study_id