Colon and/or Rectal Resection With Anastomosis for CancerGESPACENCT03097276
Management of Patients With High C-reactive Protein After Scheduled Resection of Colorectal Cancer
A study testing blood sample and CT scan in people with Colon and/or Rectal Resection With Anastomosis for Cancer, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon and/or Rectal Resection With Anastomosis for Cancer
- What is being tested?
- blood sample and CT scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteFrance
- Study dates
- 17 Apr 2017to 15 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Patients With High C-reactive Protein After Scheduled Resection of Colorectal Cancer: Pilot Study
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.
Read more
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.
- Being tested
- blood sample, CT scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleProcedure or surgery
blood sample will be collected
CT scanRadiation
CT scan
| Study group | Role | What they receive |
|---|---|---|
| Patients who underwent open decompression surgery | Other | Not described Receives: Procedure: blood sample; Radiation: CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of patients with total hospitalization of less than 15 days during the first postoperative month
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start17 Apr 2017
- Primary completion1 Oct 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon and/or Rectal Resection With Anastomosis for CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097276
- Sponsor's protocol ID
- ORTEGA CGE 2016
- Acronym
- GESPACE
- Status last verified
- Feb 2026
- First submitted
- 27 Mar 2017
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38908988
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Patients With High C-reactive Protein After Scheduled Resection of Colorectal Cancer: Pilot Study
- ClinicalTrials.gov ID
- NCT03097276
- Acronym / sponsor ID
- GESPACE / ORTEGA CGE 2016
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 17 Apr 2017 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 31 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who underwent open decompression surgery | Other | Procedure: blood sample, Radiation: CT scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampleblood sample will be collected | Procedure or surgery | Patients who underwent open decompression surgery |
| CT scanCT scan | Radiation | Patients who underwent open decompression surgery |
Primary outcome
proportion of patients with total hospitalization of less than 15 days during the first postoperative month
Time frame: 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Results publication: PubMed 38908988Gozalichvili 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample and CT scan in people with Colon and/or Rectal Resection With Anastomosis for Cancer, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
proportion of patients with total hospitalization of less than 15 days during the first postoperative month (time frame: 45 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03097276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.