Steroid before before keyhole surgery for suspected appenditis.

Preoperativ dexamethasone for patients undergoing laparoscopy for suspected appendicitis.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005040-18-DK

Enrollment

Unknown

Registered

2014-12-22

Start date

2015-03-02

Completion date

Unknown

Last updated

2017-01-09

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

Conditions

Patients undergoing laparoscopy for suspected appendicitis MedDRA version: 17.1 Level: PT Classification code 10003011 Term: Appendicitis System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Dexamethason Krka 4 mg/ml solution for injection/infusion Pharmaceutical Form: Injection INN or Proposed INN: Dexamethasone phosphate CAS Number: 312-93-6 Other descriptive name: DEXAMETHA

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
Secondary end point(s): Postoperativ pain. Postoperativ fatigue. Mobilazation. Sleep quality Consumption of analgetics Consumption of antemitics Duration of postoperativ hospitalization Duration of time until resumption of work/education. Duration of time until resumption of normal daily activities. 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. Resumption of work/education and resumption of normal daily activities will be done on the day of resumption.	—

Measure

Time frame

Secondary end point(s): Postoperativ pain. Postoperativ fatigue. Mobilazation. Sleep quality Consumption of analgetics Consumption of antemitics Duration of postoperativ hospitalization Duration of time until resumption of work/education. Duration of time until resumption of normal daily activities. 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. Resumption of work/education and resumption of normal daily activities will be done on the day of resumption.

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Countries

Denmark

Contacts

Public ContactJakob Kleif

Kirurgisk afdeling, Nordsjællands Hospital

jakob.kleif@regionh.dk+4548292005

Outcome results

None listed

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