ClinicalTrials.Veeva

Menu

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

U

University Hospital Center (CHU) Dijon Bourgogne

Status

Completed

Conditions

Colon and/or Rectal Resection With Anastomosis for Cancer

Treatments

Radiation: CT scan
Procedure: blood sample

Study type

Interventional

Funder types

Other

Identifiers

NCT03097276
ORTEGA CGE 2016

Details and patient eligibility

About

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.

Enrollment

105 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

105 participants in 1 patient group

Patients who underwent open decompression surgery
Other group
Treatment:
Procedure: blood sample
Radiation: CT scan

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems