C-protein Reactive for the Detection of Anastomotic Leakage After Surgery for Digestive Cancer

Diagnosis Accuracy of the C-protein Reactive for the Detection of Anastomotic Leakage After Surgery for Digestive Cancer

The aim of this study is to investigate the diagnostic accuracy of the C Protein Reactive (CRP) for the detection of Anastomotic leakage after surgery for digestive cancer. The standard protocol in our unit is to measure the CRP on the second and fourth postoperative day.

The main aim of the study is to investigate the diagnostic accuracy of the ratio CRP on the fourth postoperative day on CRP on the second postoperative day (CRP_D4/CRP_D2). Secondary outcomes are the diagnosis accuracy of the CRP_D4 and CRP_D2.

Study Overview

• Status: Recruiting
• Conditions: Anastomotic Leak; Digestive System Neoplasm; C-Reactive Protein
• Intervention / Treatment: Diagnostic test: C-reactive protein

Detailed Description

The occurrence of anastomotic fistula (AF) is the most feared complication after digestive cancer surgery. It is responsible for high morbidity and accounts for more than a third of the deaths observed. The rate of anastomotic fistula reported in the literature varies between 1 and 40% according to the definition chosen by the authors. In the literature, the occurrence of the anastomotic fistula is responsible for a mortality rate of 4% and an overall morbidity of 35%. In the short term, the anastomotic fistula can put the patient's vital prognosis at risk by its septic consequences. Also, it is responsible for increasing the length of stay and costs. In the longer term, anastomotic fistula affects the functional prognosis of the patient as well as oncology in patients operated for cancer.

Early rehabilitation becomes a standard in colorectal surgery, with exits around the 5th postoperative day. Anastomotic fistulas and their complications may appear well beyond. The diagnosis is made on average around 6-7 postoperative days. At an early stage, clinical signs are inconsistent and not very specific. Anastomotic fistula can manifest itself in a variety of clinical presentations, ranging from no symptoms to life-threatening septic shock. Routine imaging is neither reliable nor cost-effective for the detection of anastomotic fistulas and has the disadvantage of radiation.

It is necessary to find an intraperitoneal infection marker with a high negative predictive value. This is particularly important in the era of early rehabilitation, allowing for safe patient discharge with a low risk of readmission. C-reactive protein (CRP) has already shown its utility in the early detection of infections after digestive surgery, however, because of conflicting results, no clear recommendations are established in the literature.

Our study aims are to investigate the diagnostic accuracy of the postoperative CRP trajectory as an approach to eliminate the diagnosis of anastomotic fistula and to try to establish an optimal threshold with high sensitivity and negative predictive value.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Anass Majbar, MD; Phone Number: +212668846573; Email: anass.majbar@um5s.net.ma
• Study Contact Backup: Name: Amine Souadka, MD; Phone Number: +212666953668; Email: A.souadka@um5s.net.ma

Study Locations

• Morocco
  • Rabat, Morocco, 10090
    • Recruiting
    • National Institute of Oncology
    • Contact: Anass Majbar, MD; Phone Number: +2126688465673; Email: anass.majbar@um5s.net.ma

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients who will undergo surgical resection for digestive cancer with the creation of anastomosis will be included. The standard protocol in our unit is to measure the CRP at the second and fourth postoperative days for early detection of anastomotic leakage.

The following information will be recorded: age, gender, type of surgery, type of anastomosis, postoperative morbidity according to Clavien Grade, anastomotic leakage occurrence, infectious complications.

Description

Inclusion Criteria:

• Surgical resection for digestive cancer
• Creation of anastomosis.
• at least one measurement of CRP at the second and/or fourth postoperative day.

Exclusion Criteria:

• Surgical resection without anastomosis creation
• No measurement of CRP on the second or the fourth postoperative day.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Main group; One groupe in the study	Diagnostic test: C-reactive protein; C-reactive protein at postoperative days four and two.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRP_D4/CRP_D2	Diagnosis accuracy of the ratio CRP at the fourth on the second postoperative day after surgical resection for digestive cancer, using the receiving operating curve, sensibility, specificity, positive predictive value, and negative predictive value.	30 days after surgery
CRP_D4/CRP_D2 Colorectal	Diagnosis accuracy of the ratio CRP at the fourth on the second postoperative day after surgical resection for colorectal cancer, using the receiving operating curve, sensibility, specificity, positive predictive value, and negative predictive value.	30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CRP_D4	Diagnosis accuracy of the ratio CRP at the fourth postoperative day after surgical resection for digestive cancer, using the receiving operating curve, sensibility, specificity, positive predictive value, and negative predictive value.	30 days after surgery
CRP_D4 colorectal	Diagnosis accuracy of the ratio CRP at the fourth postoperative day after surgical resection for colorectal cancer, using the receiving operating curve, sensibility, specificity, positive predictive value, and negative predictive value.	30 days after surgery
CRP_D2	Diagnosis accuracy of the ratio CRP at the second postoperative day after surgical resection for digestive cancer, using the receiving operating curve, sensibility, specificity, positive predictive value, and negative predictive value.	30 days after surgery
CRP_D2 colorectal	Diagnosis accuracy of the ratio CRP at the second postoperative day after surgical resection for colorectal cancer, using the receiving operating curve, sensibility, specificity, positive predictive value, and negative predictive value.	30 days after surgery

Collaborators and Investigators

• Sponsor: Moroccan Society of Surgery
• Investigators: Principal Investigator: Anass Majbar, MD, National Institute of Oncology

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2018
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: October 17, 2019
• First Submitted That Met QC Criteria: October 17, 2019
• First Posted (ACTUAL): October 21, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Postoperative Complications; Gastrointestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Anastomotic Leak
• Other Study ID Numbers: CRP_study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No