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

NCT ID: NCT04133324

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2023-12-31

Brief Summary

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.

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.

Conditions

C-Reactive Protein; Anastomotic Leak; Digestive System Neoplasm

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Main group

One groupe in the study

C-reactive protein

Intervention Type: DIAGNOSTIC_TEST

C-reactive protein at postoperative days four and two.

Interventions

C-reactive protein

C-reactive protein at postoperative days four and two.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Moroccan Society of Surgery

OTHER

Sponsor Role: lead

Responsible Party

Anass Majbar

Study investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anass Majbar, MD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Oncology

Locations

National Institute of Oncology

Rabat, , Morocco

Site Status: RECRUITING

Countries

Morocco

Central Contacts

Anass Majbar, MD

Role: CONTACT

anass.majbar@um5s.net.ma

+212668846573

Amine Souadka, MD

Role: CONTACT

A.souadka@um5s.net.ma

+212666953668

Facility Contacts

Anass Majbar, MD

Role: primary

anass.majbar@um5s.net.ma

+2126688465673

Other Identifiers

CRP_study

Identifier Type: -

Identifier Source: org_study_id