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.|
|ClinicalTrials.gov Identifier: NCT03097276|
Recruitment Status : Recruiting
First Posted : March 31, 2017
Last Update Posted : January 27, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||105 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Patients who underwent open decompression surgery||
Procedure: blood sample
blood sample will be collected
Radiation: CT scan
- proportion of patients with total hospitalization of less than 15 days during the first postoperative month [ Time Frame: 45 days ]
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 ClinicalTrials.gov identifier (NCT number): NCT03097276
|Contact: Pablo ORTEGA DEBALLONfirstname.lastname@example.org|
|Chu de Dijon||Recruiting|
|Dijon, France, 21079|
|Contact: Pablo ORTEGA-DEBALLON 0380293747|