Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06318793
Status:
COMPLETED
Last Update Posted:
2024-03-20
First Post:
2024-03-12
Brief Title:
Preoperative Inflammatory Markers Predict Postoperative Complications After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Colorectal Carcinomatosis
Sponsor:
CHU de Reims
Organization:
CHU de Reims
Study Overview
Official Title:
Preoperative Inflammatory Markers Predict Postoperative Complications After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy for Peritoneal Colorectal Carcinomatosis
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A retrospective study of a single-center prospective database of patients who underwent curative CRS-HIPEC for peritoneal carcinomatosis PC of colo-rectal cancer CRC between September 2012 and July 2023 at Reims Hospital-University was conducted Inclusion criteria were patients older than 18 years with a performance status 2 who underwent complete no macroscopic residual disease CRS-HIPEC was performed Exclusion criteria were the presence of an infectious disease prior to surgery CRS without HIPEC incomplete CRS and expressed refusal to participate in the study
During the month prior to surgery patients underwent a thorough diagnostic workup including chest and abdominopelvic computed tomography CT scans complete haematological and biochemical tests and cytobacteriological analysis of urine Blood tests included leukocytes neutrophils lymphocytes platelet count albumin and CRP Within one week before surgery patients were examined by both the surgeon and the anaesthetist
Variables with a normal distribution are presented as mean-SD while those with a non-normal distribution are presented as median and range Categorical variables are presented as counts and percentages Chi-Square or Fishers exact test was used to compare qualitative variables Linear regression analysis was used to assess any association between preoperative inflammatory biomarkers and patient comorbidities and disease characteristics Preoperative levels of inflammatory biomarkers were compared between patients with no postoperative complication POC and patients with POC and major POC using the non-parametric Mann-Whitney U test Optimal cut-off values for significant inflammatory biomarkers were determined using the Youden index Receiver operating curves ROC were calculated to determine the area under the curve AUC Univariable and multivariable analyses including cut-off values of significant biomarkers were performed in a binary logistic regression analysis and expressed as odds ratios OR All tests were two-tailed and results were considered significant if the p-value was 005 Statistical analyses were performed using R software version 405
During the month prior to surgery patients underwent a thorough diagnostic workup including chest and abdominopelvic computed tomography CT scans complete haematological and biochemical tests and cytobacteriological analysis of urine Blood tests included leukocytes neutrophils lymphocytes platelet count albumin and CRP Within one week before surgery patients were examined by both the surgeon and the anaesthetist
Variables with a normal distribution are presented as mean-SD while those with a non-normal distribution are presented as median and range Categorical variables are presented as counts and percentages Chi-Square or Fishers exact test was used to compare qualitative variables Linear regression analysis was used to assess any association between preoperative inflammatory biomarkers and patient comorbidities and disease characteristics Preoperative levels of inflammatory biomarkers were compared between patients with no postoperative complication POC and patients with POC and major POC using the non-parametric Mann-Whitney U test Optimal cut-off values for significant inflammatory biomarkers were determined using the Youden index Receiver operating curves ROC were calculated to determine the area under the curve AUC Univariable and multivariable analyses including cut-off values of significant biomarkers were performed in a binary logistic regression analysis and expressed as odds ratios OR All tests were two-tailed and results were considered significant if the p-value was 005 Statistical analyses were performed using R software version 405
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None