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

NCT04133324 | Unknown

• 1 other identifier: CRP_study
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

C-Reactive Protein; Anastomotic Leak; Digestive System Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• CRP_D4

  30 days after surgery

• CRP_D4 colorectal

  30 days after surgery

• CRP_D2

  30 days after surgery

• CRP_D2 colorectal

  30 days after surgery

Study Arms (1)

Main group

One groupe in the study

Diagnostic Test: C-reactive protein

Interventions

C-reactive protein DIAGNOSTIC_TEST

C-reactive protein at postoperative days four and two.

Main group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Moroccan Society of Surgery: lead

Study Sites (1)

National Institute of Oncology

Rabat, 10090, Morocco

RECRUITING

MeSH Terms

Conditions

Anastomotic Leak; Digestive System Neoplasms

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Digestive System Diseases

Study Officials

• Anass Majbar, MD

  National Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anass Majbar, MD

CONTACT

+212668846573; anass.majbar@um5s.net.ma

Amine Souadka, MD

CONTACT

+212666953668; A.souadka@um5s.net.ma

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study investigator

Study Record Dates

• First Submitted: October 17, 2019
• First Posted: October 21, 2019
• Study Start: April 1, 2018
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 6, 2022

Record last verified: 2022-04

Locations

MO (1)