Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05547568 |
| Other study ID # |
2022Ao002* |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 2012 |
| Est. completion date |
January 2022 |
Study information
| Verified date |
October 2022 |
| Source |
CHU de Reims |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
In this study, the investigators tend to highlight pre and peroperative factors that predict
major postoperative complication after a surgery for resection of peritoneal carcinomatosis.
Factors associated with major postoperative complications were used to elaborate un
predictive nomogram model. A score was assigned for each factor of the nomogram which
correspond to the weight of the association of the factor with the occurrence of the major
postoperative complication. The nomogram assessed the probability of major postoperative
complication after surgery by adding up the scores identified on the "Points" scale for each
factor. The total score projected from the "Total points" axis to the "Risk of major
postoperative complication" axis, indicated the probability of major postoperative
complication occurrence. A cut-off of total score was calculated to identify patients at low
or high risk for major postoperative complications. The developed nomogram may be a helpful
tool to adapt postoperative monitoring of patients after surgery of peritoneal carcinomatosis
resection according to the risk of occurrence of a major postoperative complication.
Description:
This is a retrospective study from a single center of a prospectively maintained database of
patients who underwent cytoreductive surgery with hyperthermic intraperitoneal chemotherapy
for peritoneal carcinomatosis of various primitives. The postoperative monitoring was carried
out by a daily clinical examination and laboratory tests were drawn every two days during the
first postoperative week. All patients had a CT-scan when a postoperative complication was
suspected or at postoperative day 7 before hospital discharge. All patients were followed up
to 90 postoperative days. Collected variables included age, gender and body mass index (BMI),
smoking, diabetes mellitus, American Society of Anesthesiology classification of physical
health (ASA), nutritional status (albuminemia ≤ 35mg/L), preoperative hemoglobin level, tumor
origin, synchronous/metachronous peritoneal carcinomatosis, preoperative chemotherapy and/or
biotherapy, presence of ascites at surgery, Peritoneal Cancer Index, type and number of
resected organs, type and number of anastomoses, and number of packed red blood cells
transfused. Wedge resection, cauterization, or superficial excisions of the bowel wall were
not recorded. Minor hepatectomy concerned wedge resections or resection of less than 3
hepatic. Postoperative complications, recorded up to postoperative day 90, were graded
according to Clavien-Dindo classification.
The endpoint of this study was the occurrence of a major postoperative complication that was
defined as a Clavien-Dindo ≥ 3 grade complication.
To build the multivariate model the investigators used a backward stepwise approach with
removal of individual variables one by one starting with the highest p-value until all
variables had a p-value lower than 0.05. Results were presented as Odds Ratio and 95%
confidence interval. Based on the multivariate model with identified risk factors, a nomogram
was constructed to predict major postoperative complication probability after cytoreductive
surgery with hyperthermic intraperitoneal chemotherapy. The coefficients derived from the
multivariate analysis were used as weights. The nomogram assessed the probability of major
postoperative complication after cytoreductive surgery with hyperthermic intraperitoneal
chemotherapy by adding up the scores identified on the "Points" scale for each factor. The
total score projected from the "Total points" axis to the "Risk of major postoperative
complication" axis, indicated the probability of major postoperative complication occurrence
after cytoreductive surgery with hyperthermic intraperitoneal chemotherapy. The calibration
curve of the prediction model was plotted to compare the predicted and actual probability of
major postoperative complication.
The concordance index (C-index) was reported as a measure of internal validation using both
10-fold cross-validations repeated for 20 times, and bootstrap validation of 200 resamples.
The area under the receiver operating characteristic (ROC) curve (AUC) was used to evaluate
the performance of the model. The AUC is an effective method for quantifying the
discriminatory capacity of a nomogram to correctly predict patients at low or high risk of
major postoperative complication.
The Youden Index, which maximizes the sum of sensitivity and specificity, was determined
according to the ROC curve. At this threshold, the sensitivity, the specificity, the
predictive positive value (PPV), the negative predictive value (NPV) and the overall
diagnostic accuracy (i.e., probability for a patient to be classified correctly by the
nomogram) were calculated. A calibration curve was used to show consistency between the
observation frequency and prediction probability.
