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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low pneumoperitoneum pressure. | Experimental | Pneumoperitoneum pressure at 8 mmHg or lower. |
|
| standard pneumoperitoneum pressure | Active Comparator | Pneumoperitoneum pressure at 12 mmHG or higher |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low pressure pneumoperitoneum | Procedure | Low pressure pneumoperitoneum |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ramon y Cajal Hospital | Madrid | 28034 | Spain |
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Data were collected from January 2017 to May 2019
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Standard pneumoperitoneum pressure (12 mmHg or lower) during laparoscopic cholecystectomy to evaluate the peritoneal tissue damage |
| FG001 | Intervention | Low pneumoperitoneum pressure (8 mmHg or lower) during laparoscopic cholecystectomy to evaluate the peritoneal tissue damage |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
5 patients were excluded see Participant flow for more details
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | Low pneumoperitoneum pressure (8 mmHg or lower) during laparoscopic cholecystectomy to evaluate the peritoneal tissue damage |
| BG001 | Control | Standard pneumoperitoneum pressure (12 mmHg or lower) during laparoscopic cholecystectomy to evaluate the peritoneal tissue damage |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Inflammatory Peritoneal Markers | logaritmic levels of mRNA of the different markers at time 1 hour after creation of the pneumoperitoneum | 23 excluded samples | Posted | Mean | Standard Deviation | log (pg/ml) | he values will be obtained from the study of peritoneal tissue samples one hour after the creation of the pneumoperitoneum (T1). |
|
no adverse event data. All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed."
All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed."
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Standard pneumoperitoneum pressure (12 mmHg or lower) during laparoscopic cholecystectomy to evaluate the peritoneal tissue damage |
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no limitations
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Characterization of changes in peritoneal cells gene expression after standard versus low pressure l | Ramon y Cajal University Hospital | 610 312962 | +34 | aserranor@salud.madrid.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 27, 2017 | Jul 16, 2021 | Prot_SAP_000.pdf |
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| standard pneumoperitoneum pressure |
| Procedure |
standard pneumoperitoneum pressure |
|
| for surgery not performed |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI | Body mass index | Mean | Standard Deviation | kg/m^2 |
|
| ASA | American Society Anaesthesiologists classification. ASA I A normal healthy patient ASA II A patient with mild systemic disease ASA III A patient with severe systemic disease ASA IV A patient with severe systemic disease that is a constant threat to life ASA V A moribund patient who is not expected to survive without the operation ASA VI A declared brain-dead patient whose organs are being removed for donor purposes | Count of Participants | Participants |
|
|
|
|
| Primary | 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. | 13 samples excluded | Posted | Mean | Standard Error | log (pg/ml) | The values will be obtained from the study of peritoneal tissue samples one hour after the creation of the pneumoperitoneum (T1). |
|
|
|
|
| Primary | Oxidative Stress Response Marker:MDA (Malondialdehyde) | MDA (malondialdehyde) determination will be done with ELISA | It was impossible to measure MDA due to laboratory problems. | Posted | 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) |
|
|
| Primary | Apoptotic Index | This measure is reported as the mean of the difference of the percentage of apoptotic cells at baseline minus the final | 13 samples excluded | Posted | Mean | Standard Deviation | difference of the percentage | 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. |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Experimental | Low pneumoperitoneum pressure (8 mmHg or lower) during laparoscopic cholecystectomy to evaluate the peritoneal tissue damage | 0 | 0 | 0 | 0 | 0 | 0 |
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| III |
|
| IV |
|
| Unknow |
|
| Plasminogenin activator inhibitor |
|
| E- selectin |
|
| t-test, 2 sided |
| 0.028 |
| Mean Difference (Final Values) |
| 0.50 |
| Standard Error of the Mean |
| .24 |
| 2-Sided |
| 95 |
| 0.030 |
| 0.97 |
| Other |
| E-selectin | t-test, 2 sided | 0.807 | Mean Difference (Final Values) | 0.09 | Standard Error of the Mean | 0.36 | 2-Sided | 95 | -0.64 | 0.82 | Other |