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Steroid flash before colon surgery: a shot at fewer complications?

NCT ID NCT03437746

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether giving a single high dose of the steroid methylprednisolone just before colorectal surgery could lower the risk of serious complications, especially infections. The trial planned to enroll 78 adults having elective colorectal surgery, but it was terminated early, so the results are not conclusive. The idea was to calm the body's inflammatory response to surgery, which might help prevent infections and speed recovery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
methylprednisolone (a corticosteroid)
What this could lead to
If it worked, this could point toward a simple way to lower infection risk after colorectal surgery.
What could go wrong
This was a small, early pilot study that was terminated, so we don't have clear evidence it works. Steroids can also have side effects like increased infection risk.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

78 people

The number who actually took part.

Started

Mar 2018

Finished

Nov 2021

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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®

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • CHU Dijon Bourgogne

    Dijon, 21000, France

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