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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-17

Study Completion Date

2021-12-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Colon and/or Rectal Resection With Anastomosis for Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients who underwent open decompression surgery

Group Type OTHER

blood sample

Intervention Type PROCEDURE

blood sample will be collected

CT scan

Intervention Type RADIATION

CT scan

Interventions

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blood sample

blood sample will be collected

Intervention Type PROCEDURE

CT scan

Intervention Type RADIATION

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No