Steroid before before keyhole surgery for suspected appenditis.

Phase 1

Conditions: Patients undergoing laparoscopy for suspected appendicitis
MedDRA version: 17.1Level: 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: EUCTR2014-005040-18-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 appenditis.
18 years or older.
American Society of Anesthesiologits (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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Known inflammartory bowel disease.
Known autoimmun disease.
Chronic pain patient.
Presumed poor compliance.
Pregnant or breastfeeding.
In systematic treament with glucocorticoids or other immunosuppressive treatment.
Known glaucoma.
Known ocular herpes simplex.
Known cushings disease.
Known myasthenia gravis.
Vaccination 14 days or less prior to operation.

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 dexamethason can reduce postoperativ nausea and vomiting and enhance postoperativ recovery after a laparoscopy for suspected appendicitis.;Secondary Objective: To test whether preoperative dexamethason has a positiv impact on the health economic costs of a laparoscopy for suspected appendicitis. ;Primary end point(s): 50% reduction in postoperativ nausea and vomiting.;Timepoint(s) of evaluation of this end point: Depending on the time of the operation the evaluation will be done 24 to 32 hours postoperativ.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Postoperativ pain.<br>Postoperativ fatigue.<br>Mobilazation.<br>Sleep quality<br>Consumption of analgetics<br>Consumption of antemitics<br>Duration of postoperativ hospitalization<br>Duration of time until resumption of work/education.<br>Duration of time until resumption of normal daily activities.<br>Quality of recovery (QoR-15D score);Timepoint(s) of evaluation of this end point: Depending on the time of operation this will be done approximately 6 (2-10) hours, 12 (8-16) hours, 24 (24-32) hours postoperativ, and on the 2nd, 3rd, 7th, 14th and 30th postoperative day.<br>Resumption of work/education and resumption of normal daily activities will be done on the day of resumption.