Trial Outcomes & Findings for Bacterial Translocation Markers as Predictors of Infectious and Inflammatory Complications in Acute Bowel Obstruction (NCT NCT05229822)
NCT ID: NCT05229822
Last Updated: 2025-01-16
Results Overview
Аny infectious and inflammatory complications in post-operative period (wound suppuration, anastomotic leak, аbdominal abscesses, peritonitis, sepsis, etc.)
Recruitment status
COMPLETED
Target enrollment
150 participants
Primary outcome timeframe
Once (if any complication occurs during hospitalization - from 7 to 28 days)
Results posted on
2025-01-16
Participant Flow
Participant milestones
| Measure |
CRC Without ABO (Control)
60 colorectal cancer patients without acute bowel obstruction (planned operations)
Lipopolysaccharide-binding protein (LBP): Determine any presence of LBP in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
soluble CD14 subtype (sCD14-ST): Determine any presence of sCD14-ST in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
16 subunits of ribosomal ribonucleic acid (16s rRNA): Determine any presence of 16s rRNA in mesenteric lymph nodes by PCR method.
|
Malignant ABO
60 patients with malignant acute bowel obstruction
Lipopolysaccharide-binding protein (LBP): Determine any presence of LBP in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
soluble CD14 subtype (sCD14-ST): Determine any presence of sCD14-ST in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
16 subunits of ribosomal ribonucleic acid (16s rRNA): Determine any presence of 16s rRNA in mesenteric lymph nodes by PCR method.
|
Benign ABO
30 patients with benign acute bowel obstruction
Lipopolysaccharide-binding protein (LBP): Determine any presence of LBP in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
soluble CD14 subtype (sCD14-ST): Determine any presence of sCD14-ST in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
16 subunits of ribosomal ribonucleic acid (16s rRNA): Determine any presence of 16s rRNA in mesenteric lymph nodes by PCR method.
|
|---|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
30
|
|
Overall Study
COMPLETED
|
60
|
60
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Malignant ABO
n=60 Participants
60 patients with malignant acute bowel obstruction
LBP: Determine any presence of LBP in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
sCD14-ST: Determine any presence of sCD14-ST in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
16s rRNA: Determine any presence of 16s rRNA in mesenteric lymph nodes by PCR method.
TNM international classification of malignant neoplasm stages was used with grouping by stages I-IV according to the latest 8th revision of the classification.
|
CRC Without ABO (Control)
n=60 Participants
60 colorectal cancer patients without acute bowel obstruction (planned operations)
LBP: Determine any presence of LBP in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
sCD14-ST: Determine any presence of sCD14-ST in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
16s rRNA: Determine any presence of 16s rRNA in mesenteric lymph nodes by PCR method.
TNM international classification of malignant neoplasm stages was used with grouping by stages I-IV according to the latest 8th revision of the classification.
|
Benign ABO
n=30 Participants
30 patients with benign acute bowel obstruction
LBP: Determine any presence of LBP in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
sCD14-ST: Determine any presence of sCD14-ST in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
16s rRNA: Determine any presence of 16s rRNA in mesenteric lymph nodes by PCR method.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=60 Participants
|
0 Participants
n=60 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=150 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=60 Participants
|
26 Participants
n=60 Participants
|
20 Participants
n=30 Participants
|
72 Participants
n=150 Participants
|
|
Age, Categorical
>=65 years
|
34 Participants
n=60 Participants
|
34 Participants
n=60 Participants
|
10 Participants
n=30 Participants
|
78 Participants
n=150 Participants
|
|
Age, Continuous
|
67.5 years
n=60 Participants
|
66.5 years
n=60 Participants
|
59.5 years
n=30 Participants
|
66 years
n=150 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=60 Participants
|
26 Participants
n=60 Participants
|
15 Participants
n=30 Participants
|
80 Participants
n=150 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=60 Participants
|
34 Participants
n=60 Participants
|
15 Participants
n=30 Participants
|
70 Participants
n=150 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Kazakhstan
|
60 participants
n=60 Participants
|
60 participants
n=60 Participants
|
30 participants
n=30 Participants
|
150 participants
n=150 Participants
|
|
Stage of the tumor process
I
|
2 Participants
n=60 Participants • The stage of the tumor process (I-IV) is not applicable to the group "Benign ABO"
|
10 Participants
n=60 Participants • The stage of the tumor process (I-IV) is not applicable to the group "Benign ABO"
|
0 Participants
The stage of the tumor process (I-IV) is not applicable to the group "Benign ABO"
|
12 Participants
n=120 Participants • The stage of the tumor process (I-IV) is not applicable to the group "Benign ABO"
|
|
Stage of the tumor process
II
|
20 Participants
n=60 Participants • The stage of the tumor process (I-IV) is not applicable to the group "Benign ABO"
|
26 Participants
n=60 Participants • The stage of the tumor process (I-IV) is not applicable to the group "Benign ABO"
|
0 Participants
The stage of the tumor process (I-IV) is not applicable to the group "Benign ABO"
|
46 Participants
n=120 Participants • The stage of the tumor process (I-IV) is not applicable to the group "Benign ABO"
|
|
Stage of the tumor process
III
|
14 Participants
n=60 Participants • The stage of the tumor process (I-IV) is not applicable to the group "Benign ABO"
|
17 Participants
n=60 Participants • The stage of the tumor process (I-IV) is not applicable to the group "Benign ABO"
|
0 Participants
The stage of the tumor process (I-IV) is not applicable to the group "Benign ABO"
|
31 Participants
n=120 Participants • The stage of the tumor process (I-IV) is not applicable to the group "Benign ABO"
|
|
Stage of the tumor process
IV
|
24 Participants
n=60 Participants • The stage of the tumor process (I-IV) is not applicable to the group "Benign ABO"
|
7 Participants
n=60 Participants • The stage of the tumor process (I-IV) is not applicable to the group "Benign ABO"
|
0 Participants
The stage of the tumor process (I-IV) is not applicable to the group "Benign ABO"
|
31 Participants
n=120 Participants • The stage of the tumor process (I-IV) is not applicable to the group "Benign ABO"
|
PRIMARY outcome
Timeframe: Once (if any complication occurs during hospitalization - from 7 to 28 days)Аny infectious and inflammatory complications in post-operative period (wound suppuration, anastomotic leak, аbdominal abscesses, peritonitis, sepsis, etc.)
Outcome measures
| Measure |
Malignant ABO
n=60 Participants
60 patients with malignant acute bowel obstruction
LBP: Determine any presence of LBP in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
sCD14-ST: Determine any presence of sCD14-ST in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
16s rRNA: Determine any presence of 16s rRNA in mesenteric lymph nodes by PCR method.
|
CRC Without ABO (Control)
n=60 Participants
60 colorectal cancer patients without acute bowel obstruction (planned operations)
LBP: Determine any presence of LBP in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
sCD14-ST: Determine any presence of sCD14-ST in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
16s rRNA: Determine any presence of 16s rRNA in mesenteric lymph nodes by PCR method.
|
Benign ABO
n=30 Participants
30 patients with benign acute bowel obstruction
LBP: Determine any presence of LBP in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
sCD14-ST: Determine any presence of sCD14-ST in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
16s rRNA: Determine any presence of 16s rRNA in mesenteric lymph nodes by PCR method.
|
|---|---|---|---|
|
Change in Number of Participants With Post-operative Infectious and Inflammatory Complications
- Post-operative infectious complications
|
43 Participants
|
47 Participants
|
25 Participants
|
|
Change in Number of Participants With Post-operative Infectious and Inflammatory Complications
+ Post-operative infectious complications
|
17 Participants
|
13 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 1 hour before surgery, 72 hours after surgeryLBP levels will be compared between groups/ subgroups and in each group/subgroup in dynamic.
Outcome measures
| Measure |
Malignant ABO
n=60 Participants
60 patients with malignant acute bowel obstruction
LBP: Determine any presence of LBP in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
sCD14-ST: Determine any presence of sCD14-ST in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
16s rRNA: Determine any presence of 16s rRNA in mesenteric lymph nodes by PCR method.
|
CRC Without ABO (Control)
n=60 Participants
60 colorectal cancer patients without acute bowel obstruction (planned operations)
LBP: Determine any presence of LBP in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
sCD14-ST: Determine any presence of sCD14-ST in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
16s rRNA: Determine any presence of 16s rRNA in mesenteric lymph nodes by PCR method.
|
Benign ABO
n=30 Participants
30 patients with benign acute bowel obstruction
LBP: Determine any presence of LBP in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
sCD14-ST: Determine any presence of sCD14-ST in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
16s rRNA: Determine any presence of 16s rRNA in mesenteric lymph nodes by PCR method.
|
|---|---|---|---|
|
LBP Level in Serum Blood
LBP before surgery (ng/mL)
|
1164.4 ng/mL
Interval 826.4 to 1509.7
|
971.4 ng/mL
Interval 816.9 to 1277.5
|
1015.1 ng/mL
Interval 486.4 to 1543.3
|
|
LBP Level in Serum Blood
LBP on the 3rd day after surgery (ng/mL)
|
890.9 ng/mL
Interval 703.2 to 1213.7
|
897.9 ng/mL
Interval 712.5 to 1220.9
|
1180.0 ng/mL
Interval 687.1 to 1392.3
|
SECONDARY outcome
Timeframe: 1 hour before surgery, 72 hours after surgerysCD14-ST levels will be compared between groups/ subgroups and in each group/subgroup in dynamic.
Outcome measures
| Measure |
Malignant ABO
n=60 Participants
60 patients with malignant acute bowel obstruction
LBP: Determine any presence of LBP in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
sCD14-ST: Determine any presence of sCD14-ST in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
16s rRNA: Determine any presence of 16s rRNA in mesenteric lymph nodes by PCR method.
|
CRC Without ABO (Control)
n=60 Participants
60 colorectal cancer patients without acute bowel obstruction (planned operations)
LBP: Determine any presence of LBP in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
sCD14-ST: Determine any presence of sCD14-ST in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
16s rRNA: Determine any presence of 16s rRNA in mesenteric lymph nodes by PCR method.
|
Benign ABO
n=30 Participants
30 patients with benign acute bowel obstruction
LBP: Determine any presence of LBP in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
sCD14-ST: Determine any presence of sCD14-ST in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
16s rRNA: Determine any presence of 16s rRNA in mesenteric lymph nodes by PCR method.
|
|---|---|---|---|
|
sCD14-ST Level in Serum Blood
sCD14-ST before surgery (pg/mL)
|
571.7 pg/mL
Interval 342.5 to 990.0
|
245.7 pg/mL
Interval 167.9 to 403.4
|
485.2 pg/mL
Interval 277.9 to 771.0
|
|
sCD14-ST Level in Serum Blood
sCD14-ST on day 3 after surgery (pg/mL)
|
527.8 pg/mL
Interval 305.0 to 732.5
|
227.6 pg/mL
Interval 163.5 to 419.8
|
386.5 pg/mL
Interval 185.4 to 957.0
|
SECONDARY outcome
Timeframe: Once (MLN sampling in sterile conditions during surgery)Presence or absence of 16s rRNA in mesenteric lymph nodes will be compared between groups/subgroups.
Outcome measures
| Measure |
Malignant ABO
n=60 Participants
60 patients with malignant acute bowel obstruction
LBP: Determine any presence of LBP in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
sCD14-ST: Determine any presence of sCD14-ST in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
16s rRNA: Determine any presence of 16s rRNA in mesenteric lymph nodes by PCR method.
|
CRC Without ABO (Control)
n=60 Participants
60 colorectal cancer patients without acute bowel obstruction (planned operations)
LBP: Determine any presence of LBP in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
sCD14-ST: Determine any presence of sCD14-ST in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
16s rRNA: Determine any presence of 16s rRNA in mesenteric lymph nodes by PCR method.
|
Benign ABO
n=5 Participants
30 patients with benign acute bowel obstruction
LBP: Determine any presence of LBP in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
sCD14-ST: Determine any presence of sCD14-ST in blood serum by ELISA method 1 hour before surgery, 24 and 72 hours after it.
16s rRNA: Determine any presence of 16s rRNA in mesenteric lymph nodes by PCR method.
|
|---|---|---|---|
|
16s rRNA in Mesenteric Lymph Nodes
Presence of 16s rRNA
|
15 Count of Participants
|
16 Count of Participants
|
0 Count of Participants
|
|
16s rRNA in Mesenteric Lymph Nodes
Absence of 16s rRNA
|
45 Count of Participants
|
44 Count of Participants
|
5 Count of Participants
|
Adverse Events
Malignant ABO
Serious events: 0 serious events
Other events: 0 other events
Deaths: 12 deaths
CRC Without ABO (Control)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Benign ABO
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place