Peritoneal Damage in Laparoscopic Surgery

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Status: Completed

Conditions: Peritoneal Damage

Treatments: Procedure: Low pressure pneumoperitoneum; Procedure: standard pneumoperitoneum pressure

Study type: Interventional

Funder types: Other

Identifiers

NCT03020641

A-CGyD-2017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Low pneumoperitoneum pressure.

Experimental group

Description:

Pneumoperitoneum pressure at 8 mmHg or lower.

Treatment:

Procedure: Low pressure pneumoperitoneum

standard pneumoperitoneum pressure

Active Comparator group

Description:

Pneumoperitoneum pressure at 12 mmHG or higher

Treatment:

Procedure: standard pneumoperitoneum pressure