NCT03020641

Peritoneal Damage in Laparoscopic Surgery

Completed NA Results posted Last updated 22 September 2021

What this trial tests

NA trial testing Low pressure pneumoperitoneum in Peritoneal Damage in 100 participants. Completed in 28 April 2019.

Timeline

27 January 2017

Primary endpoint
28 April 2019

28 April 2019

Quick facts

Lead sponsor	Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	other
Enrollment	100
Start date	27 January 2017
Primary completion	28 April 2019
Estimated completion	28 April 2019
Sites	1 location across Spain

Drugs / interventions tested

• Low pressure pneumoperitoneum
• standard pneumoperitoneum pressure

Conditions studied

• Peritoneal Damage — all drugs for Peritoneal Damage →

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Who can join

18 and older, any sex, with Peritoneal Damage. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Inflammatory Peritoneal Markers Primary · 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

Interleukin 1

Group	Value	95% CI
Control	0.80	± 1.00
Experimental	1.14	± 1.06

Interlerukin 6

Group	Value	95% CI
Control	4.26	± 1.34
Experimental	3.24	± 1.21

Interleukin 10

Group	Value	95% CI
Control	0.76	± 1.01
Experimental	1.10	± 0.84

vascular endotelial growth factor A

Group	Value	95% CI
Control	0.09	± 0.99
Experimental	-0.05	± 0.50

Tumor necrosis factor α

Group	Value	95% CI
Control	-0.71	± 0.99
Experimental	-0.74	± 0.71

CXC lingand 2

Group	Value	95% CI
Control	2.18	± 0.99
Experimental	2.22	± 0.72

Remodeling Peritoneal Markers :( Gene Expression (mRNA) Levels of) Primary · 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.

Connective tissue growth factor

Group	Value	95% CI
Intervention	0.89	± 0.61
Control	0.61	± 0.84

Matrix metalloproteinasa-9

Group	Value	95% CI
Intervention	0.56	± 1.15
Control	0.47	± 1.31

Plasminogenin activator inhibitor

Group	Value	95% CI
Intervention	0.74	± 0.89
Control	0.24	± 1.15

E- selectin

Group	Value	95% CI
Intervention	0.66	± 139
Control	0.57	± 1.77

Apoptotic Index Primary · 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

Group	Value	95% CI
Control	-1.92	± 24.3
Experimental	-0.56	± 12.3

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.