N/A
N=100
Peritoneal Damage in Laparoscopic Surgery
Peritoneal Damage
Bottom Line
View on ClinicalTrials.gov: NCT03020641 ↗Enrolled (actual)
100
Serious AEs
—
Results posted
Sep 2021
Primary outcome: Primary: Inflammatory Peritoneal Markers — 0.80; 1.14; 4.26; 3.24 log (pg/ml) — p=0.058
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Low pressure pneumoperitoneum (Procedure); standard pneumoperitoneum pressure (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Inflammatory Peritoneal Markers |
0.80; 1.14; 4.26; 3.24; 0.76; 1.10 | 0.058 |
| PRIMARY Remodeling Peritoneal Markers :( Gene Expression (mRNA) Levels of) |
0.89; 0.61; 0.56; 0.47; 0.74; 0.24 | 0.600 |
| PRIMARY Oxidative Stress Response Marker:MDA (Malondialdehyde) |
— | — |
| PRIMARY Apoptotic Index |
-1.92; -0.56 | 0.862 |
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.
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
Data sourced from ClinicalTrials.gov (NCT03020641). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.