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Peritoneal Damage in Laparoscopic Surgery

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ClinicalTrials.gov Identifier: NCT03020641
Recruitment Status : Recruiting
First Posted : January 13, 2017
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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.

Condition or disease Intervention/treatment Phase
Peritoneal Damage Procedure: Low pressure pneumoperitoneum Procedure: standard pneumoperitoneum pressure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: Characterization of Changes in Peritoneal Cells Gene Expression After Standard Versus Low Pressure Laparoscopic Cholecystectomy and Its Clinical Correlation
Actual Study Start Date : January 27, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

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




Primary Outcome Measures :
  1. Inflammatory peritoneal markers:(gene expression (mRNA) levels of) [ Time Frame: The values will be obtained from the study of peritoneal tissue samples drawn at the beginning of the pneumoperitoneum (T 0), one hour after the creation of the pneumoperitoneum (T1) . ]
    1. "Interleukin 1, Interlerukin 6 "IL-1, IL-6.
    2. VEGF-A "vascular endothelial growth factor A".
    3. TNFα "tumor necrosis factor α".
    4. Neutrophile elastase.
    5. CXCL-2 "chemokine CXC ligand 2". Samples will be processed to obtain total RNA with TRI Reagent™ (Sigma) and will be quantified with NanoDrop spectrophotometer.

  2. Remodeling peritoneal markers :( gene expression (mRNA) levels of) [ Time Frame: The values will be obtained from the study of peritoneal tissue samples drawn at the beginning of the pneumoperitoneum (T 0), one hour after the creation of the pneumoperitoneum (T1). ]
    f. CTGF "connective tissue growth factor". g. MMP-9 "matrix metalloproteinase-9". h. HAS 1 "hyaluronic acid synthase". i. PAI-I "plasminogen activator inhibitor-I". j. E-selectin. Samples will be processed to obtain total RNA with TRI Reagent™ (Sigma) and will be quantified with NanoDrop spectrophotometer.

  3. Oxidative stress response marker:MDA (malondialdehyde) [ Time Frame: The values of the main variables will be obtained from the study of peritoneal tissue samples drawn at the beginning of the pneumoperitoneum (T 0), one hour after the creation of the pneumoperitoneum (T1) ]
    MDA (malondialdehyde) determination will be done with ELISA

  4. Apoptotic index [ Time Frame: The values of the main variables will be obtained from the study of peritoneal tissue samples drawn at the beginning of the pneumoperitoneum (T 0), one hour after the creation of the pneumoperitoneum (T1). ]
    The apoptotic index will be determined for all tissue samples by a trained pathologist using TUNNEL technique.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03020641


Locations
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Spain
Ramon y Cajal Hospital Recruiting
Madrid, Spain, 28034
Contact: Ana Serrano, MD. PhD    +34913368758    anab_serrano@yahoo.es   
Principal Investigator: Ana B. Serrano, MD. PhD         
Principal Investigator: Alfonso Sanjuanbenito, MD         
Sponsors and Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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Responsible Party: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier: NCT03020641     History of Changes
Other Study ID Numbers: A-CGyD-2017
First Posted: January 13, 2017    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal:
low pressure pneumoperitoneum
standard pressure pneumoperitoneum
laparoscopy cholecystectomy