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

NCT03097276 | Completed

• 1 other identifier: ORTEGA CGE 2016
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon and/or Rectal Resection With Anastomosis for Cancer

Outcome Measures

Primary Outcomes (1)

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

  45 days

Study Arms (1)

Patients who underwent open decompression surgery

OTHER

Procedure: blood sample; Radiation: CT scan

Interventions

blood sample PROCEDURE

blood sample will be collected

Patients who underwent open decompression surgery

CT scan RADIATION

CT scan

Patients who underwent open decompression surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Chu de Dijon

Dijon, 21079, France

Location

Related Publications (1)

• 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.

  PMID: 38908988 RESULT

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: March 31, 2017
• Study Start: April 17, 2017
• Primary Completion: October 1, 2021
• Study Completion: December 15, 2021
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

FR (1)