Elective Colorectal SurgeryPhase 2CORTICOLONNCT03437746
Impact of Preoperative Single Corticosteroid Flash on Morbidity After Colorectal Resection: Monocentric Prospective Pilot Study
A Phase 2 study testing injection of methylprednisolone at anesthetic induction and Blood samples in people with Elective Colorectal Surgery, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Complications due to infection after colorectal surgery are frequent, affecting up to 25% of patients. Infection increases mortality, lengthens hospital stays, increases costs and decreases long term survival for cancer patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Elective Colorectal Surgery
- What is being tested?
- injection of methylprednisolone at anesthetic induction and Blood samples
- Type of treatment
- Injection or infusion
- How many people
- 78 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2018to 24 Nov 2021
- Phase
- Phase 2
- 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
- Adult patient
- Patient undergoing elective colorectal surgery (diverticulitis, malignant or benign tumor, inflammatory intestinal disease, re-establishing continuity, endometriosis, or other)
- Bowel continuity is restored immediately after surgery, with or without a protective stoma.
- Patient with proper understanding who has been informed about the study, and who has consented to being part of the study
Who cannot join
- Adult under guardianship
- Patient who is not covered under the national health system
- Women who are pregnant or breastfeeding
- Colorectal resection with concomitant hyperthermic intraperitoneal chemotherapy
- Patient under long term corticosteroid therapy
- Preoperative natremia > 147 mmol/L
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- Hypokalemia (< 3,3 mmol/L)
- Patient with a contraindication to Methylprednisolone Mylan® :
- Active infection
- Active viral disease (namely hepatitis, herpes, varicella, shingles),
- A psychotic condition that is not currently treated with medication,
- Vaccination with a live vaccine or live attenuated within the last 3 months,
- Hypersensitivity to methylprednisolone or to any of the excipients found in Methylprednisolone Mylan®
Trial locations and contacts
1 site in 1 country.
About this study
Complications due to infection after colorectal surgery are frequent, affecting up to 25% of patients. Infection increases mortality, lengthens hospital stays, increases costs and decreases long term survival for cancer patients. Perioperative inflammation leads to hypercatabolism, denutrition and immunosuppression, all of which are associated to postoperative infection. Data from various sources suggests that modulating perioperative inflammatory response through the injection of corticosteroids would benefit the patient by reducing the number of postoperative complications after major surgery. Pre- or perioperative intravenous administration of a single corticosteroid flash is a means of modulating systemic inflammation that has been suggested for numerous types of surgeries, including pancreatic surgery. The objective of this study is to assess whether a preoperative single corticosteroid flash (methylprednisolone: 20 mg/kg IV at anesthetic induction) reduces the risk of serious complications after elective colorectal surgery.
- Conditions
- Elective Colorectal Surgery
- Being tested
- injection of methylprednisolone at anesthetic induction, Blood samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of methylprednisolone at anesthetic inductionDrug
intravenous administration : 20 mg/kg, over 30 minutes at anesthetic induction
Blood samplesBiological
Blood samples (D0, D1, D2, D3, D4)
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of postoperative complications, occuring up to 30 days post-operatively
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start1 Mar 2018
- Primary completion30 Sep 2021
- Study completion24 Nov 2021
Why it stopped: insufficient rate of inclusion
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 Elective Colorectal SurgeryStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 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
- NCT03437746
- Sponsor's protocol ID
- DOUSSOT AOI 2017
- Acronym
- CORTICOLON
- Status last verified
- Feb 2026
- First submitted
- 13 Feb 2018
- Last updated
- 4 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Evaluation of pre-operative high dose corticosteroids in elective colorectal surgery and effects on gut barrier function : A phase 2 clinical trial
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preoperative Single Corticosteroid Flash on Morbidity After Colorectal Resection: Monocentric Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT03437746
- Acronym / sponsor ID
- CORTICOLON / DOUSSOT AOI 2017
- Conditions
- Elective Colorectal Surgery
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: insufficient rate of inclusion
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 24 Nov 2021 (actual)
- First posted
- 19 Feb 2018 (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.
Complications due to infection after colorectal surgery are frequent, affecting up to 25% of patients. Infection increases mortality, lengthens hospital stays, increases costs and decreases long term survival for cancer patients. Perioperative inflammation leads to hypercatabolism, denutrition and immunosuppression, all of which are associated to postoperative infection. Data from various sources suggests that modulating perioperative inflammatory response through the injection of corticosteroids would benefit the patient by reducing the number of postoperative complications after major surgery. Pre- or perioperative intravenous administration of a single corticosteroid flash is a means of modulating systemic inflammation that has been suggested for numerous types of surgeries, including pancreatic surgery. The objective of this study is to assess whether a preoperative single corticosteroid flash (methylprednisolone: 20 mg/kg IV at anesthetic induction) reduces the risk of serious complications after elective colorectal surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patient
- Patient undergoing elective colorectal surgery (diverticulitis, malignant or benign tumor, inflammatory intestinal disease, re-establishing continuity, endometriosis, or other)
- Bowel continuity is restored immediately after surgery, with or without a protective stoma.
- Patient with proper understanding who has been informed about the study, and who has consented to being part of the study
Key exclusion criteria (13 listed)
- Adult under guardianship
- Patient who is not covered under the national health system
- Women who are pregnant or breastfeeding
- Colorectal resection with concomitant hyperthermic intraperitoneal chemotherapy
- Patient under long term corticosteroid therapy
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 |
|---|---|---|
| injection of methylprednisolone at anesthetic inductionintravenous administration : 20 mg/kg, over 30 minutes at anesthetic induction | Drug | – |
| Blood samplesBlood samples (D0, D1, D2, D3, D4) | Biological | – |
Primary outcome
Frequency of postoperative complications, occuring up to 30 days post-operatively
Time frame: Day 30
Results and safety
The study was stopped early (reason given: insufficient rate of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Results publicationEvaluation of pre-operative high dose corticosteroids in elective colorectal surgery and effects on gut barrier function : A phase 2 clinical trial
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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 Phase 2 study testing injection of methylprednisolone at anesthetic induction and Blood samples in people with Elective Colorectal Surgery, 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 13 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: stopped early, as of the sponsor's last update on 4 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: insufficient rate of inclusion). Results are not available in the source record.
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?
Frequency of postoperative complications, occuring up to 30 days post-operatively (time frame: Day 30). 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 NCT03437746, 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 4 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.