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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03097276
Acronym
GESPACE
Enrollment
105
Registered
2017-03-31
Start date
2017-04-17
Completion date
2021-12-15
Last updated
2026-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon and/or Rectal Resection With Anastomosis for Cancer

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.

Interventions

PROCEDUREblood sample

blood sample will be collected

RADIATIONCT scan

CT scan

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
proportion of patients with total hospitalization of less than 15 days during the first postoperative month45 days

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026