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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03097276
Recruitment Status : Recruiting
First Posted : March 31, 2017
Last Update Posted : January 27, 2020
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Colon and/or Rectal Resection With Anastomosis for Cancer Procedure: blood sample Radiation: CT scan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Management of Patients With High C-reactive Protein After Scheduled Resection of Colorectal Cancer: Pilot Study
Actual Study Start Date : April 17, 2017
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Patients who underwent open decompression surgery Procedure: blood sample
blood sample will be collected

Radiation: CT scan
CT scan

Primary Outcome Measures :
  1. proportion of patients with total hospitalization of less than 15 days during the first postoperative month [ Time Frame: 45 days ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03097276

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Contact: Pablo ORTEGA DEBALLON +33380293747

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Chu de Dijon Recruiting
Dijon, France, 21079
Contact: Pablo ORTEGA-DEBALLON    0380293747      
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
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Responsible Party: Centre Hospitalier Universitaire Dijon Identifier: NCT03097276    
Other Study ID Numbers: ORTEGA CGE 2016
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases