Back to resultsManagement of Patients With High C-reactive Protein After Scheduled Resection of Colorectal Cancer (GESPACE)
Primary Purpose
Colon and/or Rectal Resection With Anastomosis for Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample
CT scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Colon and/or Rectal Resection With Anastomosis for Cancer
Eligibility Criteria
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
Sites / Locations
- Chu de Dijon
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Patients who underwent open decompression surgery
Arm Description
Outcomes
Primary Outcome Measures
proportion of patients with total hospitalization of less than 15 days during the first postoperative month
Secondary Outcome Measures
Full Information
NCT ID
NCT03097276
First Posted
March 27, 2017
Last Updated
April 15, 2022
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT03097276
Brief Title
Management of Patients With High C-reactive Protein After Scheduled Resection of Colorectal Cancer
Acronym
GESPACE
Official Title
Management of Patients With High C-reactive Protein After Scheduled Resection of Colorectal Cancer: Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
April 17, 2017 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
December 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon and/or Rectal Resection With Anastomosis for Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
105 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients who underwent open decompression surgery
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
blood sample
Intervention Description
blood sample will be collected
Intervention Type
Radiation
Intervention Name(s)
CT scan
Intervention Description
CT scan
Primary Outcome Measure Information:
Title
proportion of patients with total hospitalization of less than 15 days during the first postoperative month
Time Frame
45 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chu de Dijon
City
Dijon
ZIP/Postal Code
21079
Country
France
12. IPD Sharing Statement
Learn more about this trial
Management of Patients With High C-reactive Protein After Scheduled Resection of Colorectal Cancer
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