Management of Patients With High C-reactive Protein After... | NCT03097276

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

NCT03097276

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Completed

Last Update Posted

Feb 6, 2026Actual

Enrollment

105Actual

Phase

Not Applicable

Conditions

Colon and/or Rectal Resection With Anastomosis for Cancer

Interventions

blood sample
CT scan

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 17, 2017Actual

Primary Completion Date

Oct 1, 2021Actual

Completion Date

Dec 15, 2021Actual

First Submitted Date

Mar 27, 2017

First Submission Date that Met QC Criteria

Mar 27, 2017

First Posted Date

Mar 31, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2026

Last Update Posted Date

Feb 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

105Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients who underwent open decompression surgery	Other		Procedure: blood sample Radiation: CT scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood sample	Procedure	blood sample will be collected	Patients who underwent open decompression surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
proportion of patients with total hospitalization of less than 15 days during the first postoperative month		45 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Chu de Dijon		Dijon		21079	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38908988	Result	Gozalichvili D, Fournel I, Sow AK, Guiraud A, Moreno-Lopez N, Orry D, Facy O, Ortega-Deballon P. Management of patients with high C-reactive protein levels after elective colorectal surgery: Pilot study on a proactive diagnostic and therapeutic approach (GESPACE). J Visc Surg. 2024 Aug;161(4):237-243. doi: 10.1016/j.jviscsurg.2024.06.002. Epub 2024 Jun 21.

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis