Steroids to patients before surgery for suspected of appendicitis.

Phase 1

Conditions: Patientns undergoing laparoscopy for suspected appendicitis
MedDRA version: 18.1Level: PTClassification code 10003011Term: AppendicitisSystem Organ Class: 10021881 - Infections and infestations
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

Registration Number: EUCTR2015-004800-46-DK

Lead Sponsor: Kirurgisk Afdeling, Nordsjællands Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): Fatigue<br>Quality of sleep<br>Use of morphine<br>Quality of recovery measured by QoR-15<br>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