跳至主要内容
临床试验/NCT05547568
NCT05547568已完成不适用

A Nomogram to Predict Major Postoperative Complications After Cytoreductive Surgery and HIPEC Based on Pre and Peroperative Criteria: Which Patient Require Intensive Monitoring? A Cohort Retrospective Study.

CHU de Reims1 个研究点 分布在 1 个国家目标入组 219 人开始时间: 2012年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
CHU de Reims
入组人数
219
试验地点
1
主要终点
Major postoperative complications (Dindo-Clavien ≥ 3 grade)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with peritoneal carcinomatosis from various origins.
  • Suitable for curative surgery
  • With a ECOG performance status ≤ 2

排除标准

  • Age < 18 years old

结局指标

主要结局

Major postoperative complications (Dindo-Clavien ≥ 3 grade)

时间窗: Follow-up to 90 postoperative days

次要结局

未报告次要终点

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验