Management of Patients With High C-reactive Protein After Scheduled Resection of Colorectal Cancer

Not Applicable

Completed

• Conditions: Colon and/or Rectal Resection With Anastomosis for Cancer
• Interventions: Procedure: blood sample; Radiation: CT scan

• Registration Number: NCT03097276
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

Anastomotic fistula is the most feared complication after surgical resection of colorectal cancer (CCR). It occurs in 6 to 15% of patients. Beyond the risk of death in the immediate postoperative period, the pain that it induces, the resources required for its management, the need for stomata with a negative impact on patients' quality of life and the prolongation of hospitalization, it also has a now-recognized adverse effect on long-term survival.

The early detection of this complication may limit its impact. C-reactive protein (CRP) has proved to be an early, reliable marker of the onset of infectious complications of colorectal surgery.

However, the diagnostic procedure to implement in these patients is not at all codified, since this population concerned by systematic CRP assay in the postoperative period is very recent.

The procedures to implement in these patients so that they can obtain the maximal benefit of an early diagnosis have not yet been established. An algorithm for the proactive clinical management must be drawn up to be able to confirm or rule out the presence of a fistula as soon as a high level of CRP is detected, and to propose a quick treatment to ensure that patients benefit from this early diagnosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-27
• Study First Submitted QC: 2017-03-27
• Study First Posted: 2017-03-31
• Study Start: 2017-04-17
• Primary Completion: 2021-10-01
• Study Completion: 2021-12-15
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-15
• Last Update Posted: 2022-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• patients aged 18 and older,
• with a CRP level > 140 mg/L at D3 or CRP > 125 mg/L at D4 following colon and/or rectal resection with anastomosis (protected or not by an upstream stoma)
• without clinical signs of severe peritonitis (fever, severe sepsis, generalized abdominal contracture)
• who have provided written informed consent.

Exclusion Criteria

• patients who have undergone intraperitoneal chemotherapy in the context of the surgical treatment for peritoneal carcinomatosis
• patients with a diagnosis of another infection that could explain the high CRP level,
• patients who underwent eventration repair at the time of the colorectal resection
• patients with an obvious indication for revisit surgery
• persons without health insurance cover
• adults under guardianship
• pregnant or beast-feeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients who underwent open decompression surgery	blood sample	-
Patients who underwent open decompression surgery	CT scan	-

Primary Outcome Measures

Name	Time	Method
proportion of patients with total hospitalization of less than 15 days during the first postoperative month	45 days

Trial Locations

Locations (1)

Chu de Dijon; 🇫🇷 Dijon, France