NCT03020641

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
14 days until next milestone

Study Start

First participant enrolled

January 27, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 28, 2019

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

September 22, 2021

Completed
Last Updated

September 22, 2021

Status Verified

September 1, 2021

Enrollment Period

2.2 years

First QC Date

January 9, 2017

Results QC Date

April 12, 2021

Last Update Submit

September 21, 2021

Conditions

Peritoneal Damage

Keywords

low pressure pneumoperitoneumstandard pressure pneumoperitoneumlaparoscopy cholecystectomy

Outcome Measures

Primary Outcomes (4)

  • 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.

Study Arms (2)

Low pneumoperitoneum pressure.

EXPERIMENTAL

Pneumoperitoneum pressure at 8 mmHg or lower.

Procedure: Low pressure pneumoperitoneum

standard pneumoperitoneum pressure

ACTIVE COMPARATOR

Pneumoperitoneum pressure at 12 mmHG or higher

Procedure: standard pneumoperitoneum pressure

Interventions

Low pressure pneumoperitoneumPROCEDURE

Low pressure pneumoperitoneum

Low pneumoperitoneum pressure.
standard pneumoperitoneum pressurePROCEDURE

standard pneumoperitoneum pressure

standard pneumoperitoneum pressure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients older than 18 years, signed informed consent, undergoing laparoscopic cholecystectomy for symptomatic cholelithiasis or gallbladder polyps.

You may not qualify if:

  • Emergency surgery.
  • Previous surgery at supramesocolic compartment.
  • Previous peritoneal inflammatory process.
  • Pregnancy or breastfeeding.
  • Patient refusal to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ramon y Cajal Hospital

Madrid, 28034, Spain

Location

Limitations and Caveats

no limitations

Results Point of Contact

Title
Characterization of changes in peritoneal cells gene expression after standard versus low pressure l
Organization
Ramon y Cajal University Hospital
aserranor@salud.madrid.org
610 312962

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2017

First Posted

January 13, 2017

Study Start

January 27, 2017

Primary Completion

April 28, 2019

Study Completion

April 28, 2019

Last Updated

September 22, 2021

Results First Posted

September 22, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)