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OpenTrials
Completed

NCT Number: NCT03097276

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

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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Key information

Conditions

Colon and/or Rectal Resection With Anastomosis for Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu de Dijon

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample

Procedure

blood sample will be collected

CT Scan

Radiation

CT scan

Primary outcomes

  1. proportion of patients with total hospitalization of less than 15 days during the first postoperative month

    Time frame: 45 days

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

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

Acronym: GESPACE

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 31, 2017
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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