Trial Outcomes & Findings for Peritoneal Damage in Laparoscopic Surgery (NCT NCT03020641)
NCT ID: NCT03020641
Last Updated: 2021-09-22
Results Overview
logaritmic levels of mRNA of the different markers at time 1 hour after creation of the pneumoperitoneum
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
he values will be obtained from the study of peritoneal tissue samples one hour after the creation of the pneumoperitoneum (T1).
Results posted on
2021-09-22
Participant Flow
Data were collected from January 2017 to May 2019
Participant milestones
| Measure |
Control
Standard pneumoperitoneum pressure (12 mmHg or lower) during laparoscopic cholecystectomy to evaluate the peritoneal tissue damage
|
Intervention
Low pneumoperitoneum pressure (8 mmHg or lower) during laparoscopic cholecystectomy to evaluate the peritoneal tissue damage
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
50
|
|
Overall Study
COMPLETED
|
48
|
47
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
Control
Standard pneumoperitoneum pressure (12 mmHg or lower) during laparoscopic cholecystectomy to evaluate the peritoneal tissue damage
|
Intervention
Low pneumoperitoneum pressure (8 mmHg or lower) during laparoscopic cholecystectomy to evaluate the peritoneal tissue damage
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Converted to open surgery
|
2
|
1
|
|
Overall Study
for surgery not performed
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Experimental
n=47 Participants
Low pneumoperitoneum pressure (8 mmHg or lower) during laparoscopic cholecystectomy to evaluate the peritoneal tissue damage
|
Control
n=48 Participants
Standard pneumoperitoneum pressure (12 mmHg or lower) during laparoscopic cholecystectomy to evaluate the peritoneal tissue damage
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.47 years
STANDARD_DEVIATION 16.88 • n=47 Participants
|
51.71 years
STANDARD_DEVIATION 15.72 • n=48 Participants
|
53.04 years
STANDARD_DEVIATION 16.26 • n=95 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=47 Participants
|
37 Participants
n=48 Participants
|
69 Participants
n=95 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=47 Participants
|
11 Participants
n=48 Participants
|
26 Participants
n=95 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
BMI
|
26.63 kg/m^2
STANDARD_DEVIATION 4.07 • n=47 Participants
|
27.51 kg/m^2
STANDARD_DEVIATION 4.6 • n=48 Participants
|
27.07 kg/m^2
STANDARD_DEVIATION 4.3 • n=95 Participants
|
|
ASA
I
|
16 Participants
n=47 Participants
|
12 Participants
n=48 Participants
|
28 Participants
n=95 Participants
|
|
ASA
II
|
23 Participants
n=47 Participants
|
32 Participants
n=48 Participants
|
55 Participants
n=95 Participants
|
|
ASA
III
|
7 Participants
n=47 Participants
|
4 Participants
n=48 Participants
|
11 Participants
n=95 Participants
|
|
ASA
IV
|
0 Participants
n=47 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=95 Participants
|
|
ASA
Unknow
|
1 Participants
n=47 Participants
|
0 Participants
n=48 Participants
|
1 Participants
n=95 Participants
|
PRIMARY outcome
Timeframe: he values will be obtained from the study of peritoneal tissue samples one hour after the creation of the pneumoperitoneum (T1).Population: 23 excluded samples
logaritmic levels of mRNA of the different markers at time 1 hour after creation of the pneumoperitoneum
Outcome measures
| Measure |
Control
n=40 Participants
Standard pneumoperitoneum pressure (12 mmHg or lower) during laparoscopic cholecystectomy to evaluate the peritoneal tissue damage
|
Experimental
n=37 Participants
Low pneumoperitoneum pressure (8 mmHg or lower) during laparoscopic cholecystectomy to evaluate the peritoneal tissue damage
|
|---|---|---|
|
Inflammatory Peritoneal Markers
Interleukin 1
|
0.80 log (pg/ml)
Standard Deviation 1.00
|
1.14 log (pg/ml)
Standard Deviation 1.06
|
|
Inflammatory Peritoneal Markers
Interlerukin 6
|
4.26 log (pg/ml)
Standard Deviation 1.34
|
3.24 log (pg/ml)
Standard Deviation 1.21
|
|
Inflammatory Peritoneal Markers
Interleukin 10
|
0.76 log (pg/ml)
Standard Deviation 1.01
|
1.10 log (pg/ml)
Standard Deviation 0.84
|
|
Inflammatory Peritoneal Markers
vascular endotelial growth factor A
|
0.09 log (pg/ml)
Standard Deviation 0.99
|
-0.05 log (pg/ml)
Standard Deviation 0.50
|
|
Inflammatory Peritoneal Markers
Tumor necrosis factor α
|
-0.71 log (pg/ml)
Standard Deviation 0.99
|
-0.74 log (pg/ml)
Standard Deviation 0.71
|
|
Inflammatory Peritoneal Markers
CXC lingand 2
|
2.18 log (pg/ml)
Standard Deviation 0.99
|
2.22 log (pg/ml)
Standard Deviation 0.72
|
PRIMARY outcome
Timeframe: The values will be obtained from the study of peritoneal tissue samples one hour after the creation of the pneumoperitoneum (T1).Population: 13 samples excluded
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.
Outcome measures
| Measure |
Control
n=37 Participants
Standard pneumoperitoneum pressure (12 mmHg or lower) during laparoscopic cholecystectomy to evaluate the peritoneal tissue damage
|
Experimental
n=40 Participants
Low pneumoperitoneum pressure (8 mmHg or lower) during laparoscopic cholecystectomy to evaluate the peritoneal tissue damage
|
|---|---|---|
|
Remodeling Peritoneal Markers :( Gene Expression (mRNA) Levels of)
Connective tissue growth factor
|
0.89 log (pg/ml)
Standard Error 0.61
|
0.61 log (pg/ml)
Standard Error 0.84
|
|
Remodeling Peritoneal Markers :( Gene Expression (mRNA) Levels of)
Matrix metalloproteinasa-9
|
0.56 log (pg/ml)
Standard Error 1.15
|
0.47 log (pg/ml)
Standard Error 1.31
|
|
Remodeling Peritoneal Markers :( Gene Expression (mRNA) Levels of)
Plasminogenin activator inhibitor
|
0.74 log (pg/ml)
Standard Error 0.89
|
0.24 log (pg/ml)
Standard Error 1.15
|
|
Remodeling Peritoneal Markers :( Gene Expression (mRNA) Levels of)
E- selectin
|
0.66 log (pg/ml)
Standard Error 139
|
0.57 log (pg/ml)
Standard Error 1.77
|
PRIMARY outcome
Timeframe: 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)Population: It was impossible to measure MDA due to laboratory problems.
MDA (malondialdehyde) determination will be done with ELISA
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 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.Population: 13 samples excluded
This measure is reported as the mean of the difference of the percentage of apoptotic cells at baseline minus the final
Outcome measures
| Measure |
Control
n=40 Participants
Standard pneumoperitoneum pressure (12 mmHg or lower) during laparoscopic cholecystectomy to evaluate the peritoneal tissue damage
|
Experimental
n=37 Participants
Low pneumoperitoneum pressure (8 mmHg or lower) during laparoscopic cholecystectomy to evaluate the peritoneal tissue damage
|
|---|---|---|
|
Apoptotic Index
|
-1.92 difference of the percentage
Standard Deviation 24.3
|
-0.56 difference of the percentage
Standard Deviation 12.3
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Experimental
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Characterization of changes in peritoneal cells gene expression after standard versus low pressure l
Ramon y Cajal University Hospital
Phone: 610 312962
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place