Keywords
Anastomotic Leak - colonic surgery - post operative complications
Introduction
Anastomotic leak after a large bowel surgery is the most dreaded complication with
incidence ranging from 1.8%[1] to 15.9%.[2] AL is also associated with increased morbidity, mortality, length of hospital stays,
general quality of life, and oncological outcomes when surgery is done in malignant
diagnoses. A proximal diversion stoma is made when the risk of AL is anticipated to
be high in a certain set of patients. This estimated risk however is subjective, it
can change from surgeon to surgeon and is not highly reliable.
The risk of AL needs to be tailored for each patient separately – based on various
factors. These factors can be broadly categorized into – baseline characteristics
which include gender, age, nutritional status, comorbidities, diagnosis ; Intraoperative
factors which include duration of surgery, type of anastomosis, location of anastomosis,
surgical technique, intraoperative complications; post-operative factors which include
the hospital setting where the post operative recovery occurs, post operative blood
transfusions, if a leak occurs- how early was it diagnosed.
In the last two decades, there have been many studies which have been done, both prospectively
and retrospectively to identify the factors that have significant effect on the probability
of anastomotic leak in large bowel surgeries. Choi HK et al,[1] in 2004 published a study, where they prospectively analyzed 1417 patients who underwent
resection and anastomosis above the peritoneal reflection for colorectal carcinoma.
It was found that the duration of hospital stays (28 days vs 10 days, p < 0/01%),
and mortality rate (32% vs 4%) was significantly higher in patients who had an anastomotic
leak post operatively. They had also concluded that American Society of Anesthesiologists
grade, whether the procedure was emergent or elective, if the patient was a smoker
or an alcohol user pre-operatively were also independent risk factors for AL.
In 2006, Konishi et al,[3] had published a prospective study where the studied the incidence of ALs in a single
center where colorectal resections have been performed from 2000-2004 by a single
surgeon. 11 patients out of 391 (2.8%) had AL. Preoperative steroid use, longer intraoperative
time were independently predictive of the incidence of anastomotic leak.
When a patient gets diagnosed with a colonic pathology (benign or malignant), to make
a surgical treatment plan for the patient, multiple factors need to be taken into
consideration and the plan should be tailored to each patient separately, rather than
a community or an age group or a set of diagnoses.
However, most data and studies combine both colon and rectal surgeries, because of
this, factors specific to colon surgery are often obscured by risk factors which are
typical to rectal surgeries – like male sex, level of mesenteric artery ligation,
distance of the tumor form the anal verge, and the use of neoadjuvant radiotherapy
(which is more commonly done in rectal carcinomas).
Kraup PM et al,[4] in 2012 published a study in Denmark, where 9333 patients who underwent curative
colonic resection with a primary anastomosis without a stoma were studied. AL occurred
in 593 (6.4%) patients. Laparoscopic surgery, left hemicolectomy, sigmoid colectomy,
intraoperative blood loss and blood transfusions, and male gender were found to be
associated with an increased risk of AL.
Majority of the studies identify risk factors but don't provide an accurate instrument
to estimate the risk of AL in daily clinical practise. If a tool like that can be
made, patients at a higher risk of AL can be identified preoperatively, and their
surgical plan can be modified, a diversion stoma could be made, or an anastomosis
could be avoided, accordingly.
In 2015, the ANACO study group published a multicentric, prospective study done in
Spain from September 2011 to September 2012.[5]
They aimed to determine the pre-operative and intra-operative risk factors for anastomotic
leak after colon resection and to create a practical instrument to predict the leak.
They included 3193 patients, evaluated 42 pre-operative and intraoperative factors,
and studied the occurrence of AL in 60 days post-surgery. Using univariate and multivariate
analysis, they identified obesity, intra-op complications, pre-op serum protein levels,
male sex, hospital beds, and ongoing anticoagulants as statistically significant factors
for AL. Based on this, they developed a nomogram using a logistic regression model
which can be used to calculate the AL risk percentage for each patient.
This nomogram has been externally validated by multiple studies. Sammour et al, in
a retrospective analysis published in 2017,[6] compared this Anastomotic Leak Risk Calculator to American College of Surgeons National
Surgical Quality Improvement Program® (ACS NSQIP) calculator[7] and the colon leakage score (CLS) calculator for left colectomy. In another prospective
analysis, this calculator has been proven to be superior to the surgeon's estimate
of AL after colon cancer resection.[8]
In our study, the Anastomotic leak risk calculator[5] is being evaluated in colonic surgeries being performed in our institution.
Methodology
Aim:
To evaluate the Anastomotic Leak Risk Calculator in predicting the outcome of Colonic
Anastomosis in right-sided and left-sided colonic surgeries
Objectives:
-
To calculate and compare the Anastomotic Leak Risk Score pre-operatively and post-operatively
considering intraoperative complications as an independent variable
-
To identify pre-operative and intra-operative variables that are significant in predicting
anastomotic leak
Study Design
This is a prospective, observational study, done in a single center, from November
2022 to May 2024. The departments of General Surgery, Surgical Oncology, Gastrointestinal
Surgery, at Kasturba Medical College, Manipal were included. Our study was a time-bound
study, and it included all the patients who fit the inclusion criteria admitted during
the study duration, hence, the sample size was 89.
Inclusion and Exclusion Criteria
Inclusion and Exclusion Criteria
Inclusion Criteria
Patients who underwent colectomy on an emergency/elective basis with or without a
protective stoma between November 2022 to May 2024
Exclusion Criteria
Materials and Methods-
Prior approval was sought from the institutional ethics committee. After obtaining
informed consent from the patient, information was collected in a proforma. The data
was then used to derive the Anastomotic Leak Risk Score using the Anastomotic Leak
Risk Calculator (www.anastomoticleak.com).[5] This calculator was chosen for the study as it is widely used with multiple validation
studies and has also been included in the European Society of Coloproctology (ESCP)
driven 2019 Safe-anastomosis Programme in Colorectal Surgery (EAGLE).[9] The variables included in this calculator are gender, BMI, on anticoagulants, intra
operative complications, serum protein level, hospital size (number of beds).
Outcome
The outcome was to look for anastomotic leak 30 days post operatively
Definitions
“Leak of luminal contents from a surgical join between 2 hollow viscera” diagnosed
-
(1) radiologically, by a radiographic enema with hydro-soluble contrast or by computerized tomography
(CT) with presence of intra- abdominal collection adjacent to the anastomosis
-
(2) clinically, with evidence of extravasation of bowel content or gas through a wound or drain
-
(3) by endoscopy
-
(4) intraoperatively.
Data Analysis
Categorical data was summarized by frequency and percentages. Quantitative data was
summarized by mean and standard deviation. Comparison of categorical data was performed
by Chi-square test and Fisher's exact test. Quantitative data was compared by t-test.
SPSS 23 software was used to analyze the data. The level of significance was 5%. A
multivariate regression analysis has not been performed as our primary objective was
to evaluate the Anastomotic leak risk calculator in predicting the risk of ALs. Had
the objective been to develop a nomogram to predict ALs in our study setting, a multivariate
regression analysis may have been used.
Results
The descriptive statistics of the study population are tabulated below ([Table 1]):
Table 1
Descriptive statistics of the study population
|
Variables
|
N (%)
|
Baseline Characteristics
|
Gender
|
Male
|
55 (61.8%)
|
Female
|
34 (38.2%)
|
Anticoagulant usage
|
Not on anticoagulants
|
78 (87.6%)
|
Taking but stopped preoperatively
|
7 (7.9%)
|
Taking at the time of surgery
|
4 (4.5%)
|
Age
|
30 years and below
|
9 (10.1%)
|
31 - 50 years
|
25 (28.1%)
|
51 - 70 years
|
39 (43.8%)
|
Above 70 years
|
16 (18%)
|
Diagnosis
|
Malignancy
|
60 (67.4%)
|
Benign
|
26 (29.2%)
|
Mesenteric ischemia
|
3 (3.4%)
|
Variables related to the surgery
|
Name of the surgery
|
Emergency
|
17 (19.1%)
|
Elective
|
72 (80.9%)
|
Type of the surgery
|
Open
|
63 (71%)
|
Laparoscopic
|
22 (25%)
|
Laparoscopic converted to open
|
4 (4%)
|
Site of the anastomosis
|
Colo-colic (left side)
|
28 (31.5%)
|
Ileo-colic (right side)
|
61 (68.5%)
|
Type of the anastomosis
|
End to end
|
17 (19.1%)
|
Side to side
|
70 (78.7%)
|
End to side
|
2 (2.2%)
|
Handsewn vs stapled
|
Handsewn
|
40 (45%)
|
Stapled
|
49 (55%)
|
Covering stoma
|
No
|
82 (92.1%)
|
Yes
|
7 (7.9%)
|
Intraoperative complications
|
Yes
|
33 (37%)
|
Post operative outcomes
|
Time from surgery to discharge
|
3 - 5 days
|
37 (41.5%)
|
6 - 10 days
|
30 (33.7%)
|
Above 10 days
|
22 (24.7%)
|
[Table 2] summarizes the values of BMI.
Table 2
BMI range in the study population
BMI
|
Number (total = 89)
|
%
|
>30 kg/m2
|
10
|
11.2%
|
<30kg/m2
|
79
|
88.8%
|
([Graph 1])
Graph 1 summarizes the serum protein distribution in the study population.
[Table 3] summarizes the quantitative data analyzed in the study.
Table 3
Quantitative data analysed in the study
|
N
|
Minimum
|
Maximum
|
Mean
|
Std Deviation
|
BMI
|
89
|
13.15
|
38.46
|
23.93
|
5.18
|
Serum protein
|
89
|
4.5
|
8.4
|
6.71
|
0.934
|
Time from surgery to discharge
|
89
|
3
|
46
|
9.66
|
6.403
|
Age
|
89
|
19
|
88
|
53.87
|
16.221
|
Anastomotic Leak-
[Tables 4], [5], [6] summarize the incidence of anastomotic leak in our study population, mode of diagnosis
of AL and treatment for the AL.
Table 4
Incidence of AL in the study population
Anastomotic Leak Diagnosed
|
Number (n = 89)
|
Percentage
|
No
|
83
|
93.3%
|
Yes – Disruption of Anastomosis
|
4
|
4.5%
|
6.7%
|
Yes – Enterocutaneous fistula
|
2
|
2.2%
|
Table 5
Mode of diagnosis of AL
Mode of diagnosis
|
Number
|
Percentage
|
Clinical
|
2
|
33.4%
|
Radiological
|
4
|
66.6%
|
Intra-operatively
|
0
|
0%
|
Endoscopic
|
0
|
0%
|
Table 6
Treatment given for AL
Treatment
|
Number
|
Percentage
|
Re-operation
|
4
|
66.6%
|
Antibiotics
|
2
|
33.4%
|
Variables Compared with the Incidence of Anastomotic Risk
Variables Compared with the Incidence of Anastomotic Risk
[Table 7] summarizes the baseline characteristics of the study population compared with incidence
of AL.
Table 7
Baseline characteristics of the study population compared with the incidence of AL
|
Variables compared with the incidence of
Anastomotic leak
|
N (%)
|
Anastomotic leak
|
Number (% in category)
|
Percentage in total anastomotic
leak
|
p-value
|
Baseline characteristics
|
Gender
|
Male
|
55 (61.8%)
|
Present
Absent
|
2 (3.6%)
53 (96.4%)
|
2 out of 6 ALs (33.3%) occurred in Males
|
0.137 (Chi-square) (NS)
|
Female
|
34 (38.2%)
|
Present
Absent
|
4 (11.8%)
30 (88.2%)
|
4 out of 6 ALs (66.6%) occurred in females
|
Anticoagulant usage
|
Not on anticoagulants
|
78 (87.5%)
|
Present
Absent
|
5 (6.4%)
73 (93.6%)
|
5 out of 6 ALs (83.3%) occurred in patients not on anticoagulants
|
0.267 (Fisher's exact) (NS)
|
Taking but stopped preoperatively
|
7 (7.9%)
|
Present
Absent
|
0 (0%)
7 (100%)
|
|
Taking at the time of surgery
|
4 (4.5%)
|
Present
Absent
|
1 (25%)
3 (75%)
|
1 out 6 ALs (16.6%) occurred in patients taking anticoagulants
|
Age
|
30 years and below
|
9 (10.1%)
|
Present
Absent
|
1 (11.1%)
8 (88.9%)
|
1 out of 6 ALs (16.6%) occurred in patients of age 30 yrs and below
|
0.476 (Fisher's exact) (NS)
|
31-50 years
|
25 (28.1%)
|
Present
Absent
|
1 (4%)
24 (96%)
|
1 out of 6 ALs (16.6%) occurred in patients of age 31-50 yrs
|
51-70 years
|
39 (43.8%)
|
Present
Absent
|
4 (10.3%)
35 (89.7%)
|
4 out of 6 ALs (66.6%) occurred in patients between 51-70 yrs
|
Above 70 years
|
16 (18%)
|
Present
Absent
|
0 (0%)
16 (100%)
|
0%
|
Diagnosis
|
Malignancy
|
60 (67.4%)
|
Present
Absent
|
2 (3.3%)
58 (96.7%)
|
2 out of 6 ALs (33.3%) occurred in malignant conditions
|
0.066 (Fisher's exact) (NS)
|
Benign
|
26 (29.2%)
|
Present
Absent
|
3 (11.5%)
23 (88.5%)
|
3 out of 6 ALs (50%) occurred in benign conditions
|
Mesenteric ischemia
|
3 (3.4%)
|
Present
Absent
|
1 (33.3%)
2 (66.7%)
|
1 out of 6 ALs (16.6%) occurred in mesenteric ischemia
|
[Table 8] summarizes the operative variables of the study population compared with incidence
of AL.
Table 8
Variable related to the surgery compared with the incidence of AL
|
Variables compared with the incidence of anastomotic leak
|
N (%)
|
Anastomotic leak
|
Number (% in category)
|
% of total leaks
|
p-value
|
Variables related to the surgery
|
Name of the surgery
|
Emergency
|
17 (19.1%)
|
Present
Absent
|
0 (0%)
17 (100%)
|
0 out of 6 ALs occurred in emergency
surgeries
|
0.218 (Chi-square test) (NS)
|
Elective
|
72 (80.9%)
|
Present
Absent
|
6 (8.3%)
66 (91.7%)
|
6 out 0f 6 ALs
(100%) occurred in elective surgeries
|
Type of the surgery
|
Open
|
63 (71%)
|
Present
Absent
|
6 (9.5%)
57 (90.5%)
|
6 out of 6 ALs occurred in open procedures (100%)
|
0.265 (Fisher's exact test) (NS)
|
Laparoscopic
|
22 (25%)
|
Present
Absent
|
0 (0%)
22 (100%)
|
Laparoscopic converted to open
|
4 (4%)
|
Present
Absent
|
0 (0%)
4 (100%)
|
Site of the anastomosis
|
Colo-colic (left side)
|
28 (31.5%)
|
Present
Absent
|
4 (14.3%)
24 (85.7%)
|
4 out of 6 ALs (66.6%) occurred in left sided
anastomosis
|
0.004
(Fisher's exact test) (HS)
|
Ileo-colic (right side)
|
61 (68.5%)
|
Present
Absent
|
2 (3.2%)
59 (96.8%)
|
2 out of 6 ALs (33.3%) occurred in
left sided anastomosis
|
Type of the anastomosis
|
End to end
|
17 (19.1%)
|
Present
Absent
|
2 (11.8%)
15 (88.2%)
|
2 out of 6 (33.3%) ALs occurred in E-E
|
0.624
(Fisher's exact test) (NS)
|
Side to side
|
70 (78.7%)
|
Present
Absent
|
4 (5.7%)
66 (94.3%)
|
4 out of 6 (66.6%) ALs occurred in S-S
|
End to side
|
2 (2.2%)
|
Present
Absent
|
0 (0%)
2 (100%)
|
|
Handsewn vs stapled
|
Handsewn
|
40 (45%)
|
Present
Absent
|
4 (10%)
36 (90%)
|
4 out of 6 ALs
(66.6%) occurred in handsewn
|
0.218 (Chi
square test) (NS)
|
Stapled
|
49 (55%)
|
Present
Absent
|
2 (4.1%)
47 (95.9%)
|
2 out of 6 ALs
(33.3%) occurred in stapled
|
Covering stoma
|
No
|
82 (92.1%)
|
Present
Absent
|
6 (7.3%)
76 (92.7%)
|
6 out of 6 ALs occurred in patients without stoma
|
0.459
(Fisher's exact test) (NS)
|
Yes
|
7 (7.9%)
|
Present
Absent
|
0 (0%)
7 (100%)
|
|
Intraoperative complications
|
Yes
|
33 (37%)
|
Present
Absent
|
2 (6%)
31 (94%)
|
Only 2 of the 6 ALs
(33.3%) had intraoperative complications
|
0.890
(Chi-square test) (NS)
|
[Table 9] summarizes the post operative outcomes of the study population compared with incidence
of AL.
Table 9
Post operative outcomes compared with the incidence of AL
|
Variables compared with the incidence of anastomotic leak
|
N (%)
|
Anastomotic leak
|
Number (% in category)
|
% of total
leaks
|
p-value
|
Post operative outcomes
|
Time from surgery to discharge
|
3-5 days
|
37 (41.5%)
|
Present
Absent
|
0 (0%)
37 (100%)
|
0%
|
0.002 (Chi-square test) (HS)
|
6-10 days
|
30 (33.7%)
|
Present Absent
|
1 (3.3%)
29 (96.7%)
|
1 out of 6 ALs had hospital stay over 5 days
|
Above 10 days
|
22 (24.7%)
|
Present Absent
|
5 (22.7%)
17 (77.3%)
|
5 out of 6 ALs had hospital stay over 10 days
|
Anastomotic Leak Risk Scores
Anastomotic Leak Risk Scores
Preoperatively Calculated Anastomotic Leak Risk Score
Preoperative anastomotic leak scores are categorized in [Table 10]
Table 10
Preoperative Anastomotic Leak Risk Score
Preoperative anastomotic leak risk score
|
Number (n =89)
|
Percentage
|
Less than 5%
|
34
|
38.2%
|
5% - 10%
|
38
|
42.7%
|
11% - 20%
|
16
|
18%
|
Above 20%
|
1
|
1.1%
|
Post-Operatively Calculated Anastomotic Leak Risk Score
Post operative anastomotic leak scores are categorized in [Table 11]
Table 11
Postoperative Anastomotic Leak Risk Score
Post-operative anastomotic leak risk score
|
Number (n =89)
|
Percentage
|
Less than 5%
|
25
|
28.1%
|
5% - 10%
|
33
|
37.1%
|
11% - 20%
|
23
|
25.8%
|
Above 20%
|
8
|
9%
|
([Graph 2])
Graph 2 shows the comparison between preoperative and post operative anastomotic leak risk
scores.
The preoperative and post operative anastomotic leak risk scores were compared with
the incidence of AL. the summary of this is depicted in [Table 12].
Table 12
Comparision of preoperative and postoperative anastomotic leak risk score with incidence
of AL
Anastomotic leak diagnosed
|
N
|
Mean
|
Std. Deviation
|
t test p value
|
|
pre op score (%)
|
Yes
|
6
|
8.83
|
3.19
|
0.483
|
NS
|
No
|
83
|
7.69
|
3.89
|
post op score (%)
|
Yes
|
6
|
11.17
|
5.04
|
0.661
|
NS
|
No
|
83
|
9.98
|
6.46
|
Using t test, comparing the preoperative anastomotic leak risk score and Incidence
of Anastomotic leak, p-value was determined to be 0.483, which is statistically not
significant. Using the t-test, comparing the post operative anastomotic leak risk
score and Incidence of Anastomotic leak, p-value was determined to be 0.661, which
is statistically not significant
Intra Operative Complications and Anastomotic Leak Risk Score
Using occurrence of intra operative complications as an independent variable, pre-operative
and post operative Anastomotic leak risk scores were calculated and data was analyzed.
Results are shown in [Table 13], [14].
Table 13
Intraoperative complications and Anastomotic Leak Risk Score (Preoperatively)
Pre-operative Anastomotic Leak Risk Score
|
Intra operative complications - Yes
|
Intra operative complications - No
|
Number
|
Percentage
|
Number
|
Percentage
|
Less than 5%
|
11
|
32.4%
|
23
|
67.6%
|
5% - 10%
|
14
|
36.8%
|
24
|
63.2%
|
11% - 20%
|
7
|
43.8%
|
9
|
56.3%
|
More than 20%
|
0
|
0%
|
1
|
100%
|
Table 14
Intraoperative complications and Anastomotic leak risk score (Postoperatively)
Post operative Anastomotic Leak Risk Score
|
Intra operative complications - Yes
|
Intra operative complications - No
|
Number
|
Percentage
|
Number
|
Percentage
|
Less than 5%
|
2
|
8%
|
23
|
92%
|
5% - 10%
|
19
|
27.3%
|
24
|
72.7%
|
11% - 20%
|
14
|
60.9%
|
9
|
39.1%
|
More than 20%
|
7
|
87.5%
|
1
|
12.5%
|
Using Chi square test, the significance of the effect of presence of Intraoperative
complications on the post operative anastomotic leak risk score has been assessed.
p-value was determined to be <0.001 which is highly significant
Outcome at 30 Days in the Study Population
Outcome at 30 Days in the Study Population
[Table 15] summarizes the outcome of the study population at 30 days post-surgery
Table 15
Outcome at 30 days
Outcome at 30 days
|
Number (n = 89)
|
Percentage
|
Discharged
|
78
|
87.6%
|
Leak present – treated by reoperation
|
2
|
2.2%
|
Leak present – treated by Antibiotics
|
2
|
2.2%
|
Death
|
7
|
7.9%
|
Out of the seven deaths, 2 deaths (28.6% of total deaths) were due to anastomotic
leak.
Whereas 5 deaths (71.4% of total deaths) were due to other causes. (2 deaths – ARDS,
1 death – Intractable seizures, 1 death – Severe metabolic acidosis, 1 death – urosepsis,
Congestive cardiac failure.
Using Fisher's exact test, comparing the outcome at 30 days and Incidence of Anastomotic
leak, p-value was determined to be < 0.001, which is statistically highly significant
Discussion
The anastomotic leak risk calculator[5] has been validated by two studies as described earlier.[6]
[8] In April 2022, Izel Omen at al published a multicenter prospective study using data
collected from 2016–2019 at 14 hospitals in Australia and Netherlands.[10] The broadly included 643 patients who underwent colonic surgery with an anastomosis.
They have concluded that the anastomotic leak risk calculator[5] could not be validated in their study population. Low pre-operative hemoglobin,
intraoperative hypothermia, contamination of the operative field and use of epidural
analgesia were identified as independent risk factors for AL. In retrospection, the
reasons for failure of the Anastomotic leak risk calculator in predicting ALs in our
study population could be due to two factors, one – the lower number of study population,
two – the shorter follow up period. Since this study was a single center study, it
included only patients from a single tertiary care center which would, had it been
a multicentered study, it would have been possible to achieve a more sample size which
is representative of the population. The previous studies which validated the anastomotic
leak risk calculator have been tested only on right sided colonic surgeries[6]
[8] whereas our study had considered both right and left sided colonic anastomoses which
could have led to variation in the results. Since the follow up period in our study
has been only 30 days, delayed presentations such as an enterocutaneous fistula could
have been missed.
There have been many scores developed in the literature, using various factors that
affect the healing of an anastomosis as variables. Notable ones have been compared
to the current calculator.
Frasson et al.[5] did a study where 42 pre-/intraoperative variables, related to patient, tumor, surgical
procedure, and hospital, were analyzed as potential independent risk factors for anastomotic
leak with a 60 day follow up. A nomogram was created to easily predict the risk of
anastomotic leak for a given patient. Anastomotic leak significantly increased mortality
and length of hospitalization. In the multivariate analysis, obesity, preoperative
serum total proteins, male sex, ongoing anticoagulant treatment, intraoperative complication,
and number of hospital beds were identified to be independent risk factors for predicting
AL.
Mc. Kenna[11] et al published a study with the data from ACS- NSQIP from 2012-2016 amongst patients
undergoing elective left sided colon resection for a malignant or a benign disease.
Independent risk factors for anastomotic leak included younger age, male sex, tobacco
use, and omission of combined bowel preparation.
Rencyzogullari A, et al. developed a nomogram using the ACS-NSQIP data amongst elderly
patients undergoing colectomy.[12] The duration of follow up post OT was 30 days. Based on unadjusted analysis, factors
associated with an increased risk of an anastomotic leak were ASA score III and IV,
chronic obstructive pulmonary disease, diabetes mellitus, smoking history, weight
loss, previously infected wound, omitting mechanical bowel preparation and/or preoperative
oral antibiotic use, and wounds classified as contaminated or dirty/infected. Patients
who developed an anatomic leak had a longer length of hospital stay and operative
time. A multivariate model and nomogram were created.
Rojas Machado et al, developed a PROCOLE score using a meta-analysis of observational
studies of risk factors for predicting AL in patients undergoing colorectal cancer
surgery.[13] The study involved a comprehensive review of observational studies to identify risk
factors for AL. Based on the meta-analysis, significant risk factors for AL were selected.
The PROCOLE index was created by incorporating these risk factors into a scoring system.
Each risk factor was assigned a weight based on its association with AL. The PROCOLE
index was validated using data from a separate cohort to assess its predictive accuracy
and clinical utility. Risk Factors identified were – age, comorbidities, and nutritional
status, type of anastomosis, surgical technique, and operative time, tumor location
and stage. The index showed good performance metrics, including sensitivity, specificity,
and an area under the receiver operating characteristic (ROC) curve.
Pasic et al, developed a score to predict AL after elective colorectal cancer surgery.[14] A total of 159 patients were divided into test (79 patients) and validation (40
patients) groups to identify the risk factors and construct the predictive score.
The remaining 40 patients (intervention group) were prospectively evaluated with the
application of protective measures guided by risk stratification according to the
predictive score. The study identified several significant predictors of AL, including
age, and nutritional status, type of anastomosis, operative time, and intraoperative
complications, tumor location and stage. The predictive score combined these risk
factors into a numerical value that estimates the risk of AL. The predictive score
was used to guide decisions about implementing protective measures, such as creating
an ostomy, for high-risk patients.
Our study was performed in a single center, prospectively, included 89 patients undergoing
elective/emergent colonic surgeries (benign / malignant). Cases which had colorectal
resection were excluded. The statistical analysis has revealed that the site of anastomosis
(whether it is right sided or left side) significantly effects the anastomotic leak
probability (p = 0.004). The incidence of AL significant influences the duration of
hospital stays (p = 0.002) and 30 day outcomes (p < 0.001).
The comparisons of these studies have been made in [table 16] below:
Table 16
Comparision of similar studies
Summary
|
Current study
|
Frasson et al
|
McKenna et al
|
Rencyzogullari A et al
|
Rojas Machado et al
|
Pasic et al
|
Year
|
2024
|
2015
|
2019
|
2017
|
2016
|
2013
|
Country
|
India
|
Spain
|
USA
|
USA
|
Spain
|
Bosnia
|
Retrospective/
Prospective
|
Prospective
|
Prospective
|
Retrospective
|
Retrospective
|
Meta analysis, systematic review
|
Prospective
|
Single vs multicentric
|
Single center
|
Multicentric
|
Multicentric
|
Multicentric
|
Multicentric
|
Single center
|
Score name
|
−
|
Anastomotic leak risk score
|
−
|
−
|
PROCOLE
|
−
|
No. of patients included
|
89
|
3193
|
38475
|
10,392
|
Various factors were weighed in, not patients
|
159
|
Type of surgery included
|
Right and left colonic surgeries (excl rectal)
|
Right and left colonic surgeries (excl rectal)
|
Left sided colonic surgery
|
All colorectal surgery
|
All colorectal surgery
|
All colorectal surgery
|
AL %
|
6.7%
|
8.7%
|
3.3%
|
3.2%
|
|
8.7%
|
Conclusion
Anastomotic leak percentage in our study – 6.7% (6 out of 89 patients). The anastomotic
leak risk calculator has not proven to be significant in predicting the risk of anastomotic
leaks in our study population. The occurrence of intraoperative complications has
a significant effect on the post operative anastomotic leak risk score. There is significant
effect of the Site of anastomosis – left sided or right sided on the probability of
occurrence of AL. The time from surgery to discharge of the patient is significantly
affected by the occurrence of anastomotic leak. The incidence of AL significantly
affects the 30-day outcome of the patient post-surgery. However, studies with a longer
study duration and a longer follow up period are indicated to further analyze and
evaluate the Anastomotic leak risk calculator.
Bibliographical Record
Varsha Chinta, Badareesh Lakshminarayana, Roshen Samuel. Anastomotic Leak Risk Calculator
– Can it be Used to Predict Anastomotic Leaks in Colonic Surgeries?. Journal of Coloproctology
2025; 45: s00451804914.
DOI: 10.1055/s-0045-1804914