Steroids to patients before surgery for suspected of appendicitis.

Preoperative methylprednisolone to patients suspected of appendicitis undergoing laparoscopy. - Prednisolon study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004800-46-DK

Enrollment

Unknown

Registered

2015-11-20

Start date

2016-01-21

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patientns undergoing laparoscopy for suspected appendicitis MedDRA version: 18.1 Level: PT Classification code 10003011 Term: Appendicitis System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Solu-Medrol Pharmaceutical Form: Granules and solvent for suspension for injection INN or Proposed INN: Methylprednisolone Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnostic laparoscopy for suspected appendicitis Age 18 years or older American Society of Anesthesiologist (ASA) class I-III. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

Exclusion criteria: Known inflammatory bowel disease. Known autoimmune disease. Chronic pain patient. Presumed poor compliance. Pregnant or breastfeeding. In systematic treatment with glucocorticoids or other immunosuppressive treatment. Known renal disease, GFR<30. Known liver cirrhosis. Known heart faillure, EF<40%. Known glaucoma. Known ocular herpes simplex. Known cushings disease. Known myasthenia gravis. Vaccination 14 days or less prior to surgery.

Design outcomes

Primary

Measure	Time frame
Main Objective: To test whether preoperative methylprednisolone can reduce postoperative pain after laparoscopy for suspected appendicitis.;Secondary Objective: To test whether preoperative methylprednisolone can reduce postoperative fatigue, nausea and vomiting, duration of convalescence and increase overall quality of recovery after laparoscopy for suspected appendicitis.;Primary end point(s): 30% rduction in postoperative pain;Timepoint(s) of evaluation of this end point: Evaluation of primary endpoint approximately 6, 12, 24 hour and on postoperative day 2 and 3.	—

Measure

Time frame

Main Objective: To test whether preoperative methylprednisolone can reduce postoperative pain after laparoscopy for suspected appendicitis.;Secondary Objective: To test whether preoperative methylprednisolone can reduce postoperative fatigue, nausea and vomiting, duration of convalescence and increase overall quality of recovery after laparoscopy for suspected appendicitis.;Primary end point(s): 30% rduction in postoperative pain;Timepoint(s) of evaluation of this end point: Evaluation of primary endpoint approximately 6, 12, 24 hour and on postoperative day 2 and 3.

—

Secondary

Measure	Time frame
Secondary end point(s): Fatigue Quality of sleep Use of morphine Quality of recovery measured by QoR-15 Duration of convalescence;Timepoint(s) of evaluation of this end point: Evaluated approximately 6, 12, 24 hours postoperative, and on the 2nd, 3rd, 7th, 14th and 30th postoperative day	—

Countries

Denmark

Contacts

Public ContactJakob Kleif

Kirurgisk Afdeling, Nordsjællands Hospital

jakob.kleif@regionh.dk

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026