E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients undergoing laparoscopy for suspected appendicitis |
|
E.1.1.1 | Medical condition in easily understood language |
Patients who undergo keyhole surgery for suspected appendicitis |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10003011 |
E.1.2 | Term | Appendicitis |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To test whether preoperative dexamethason can reduce postoperativ nausea and vomiting and enhance postoperativ recovery after a laparoscopy for suspected appendicitis. |
|
E.2.2 | Secondary objectives of the trial |
To test whether preoperative dexamethason has a positiv impact on the health economic costs of a laparoscopy for suspected appendicitis. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Diagnostic laparoscopy for suspected appenditis.
18 years or older.
American Society of Anesthesiologits (ASA) class I-III. |
|
E.4 | Principal 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. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
50% reduction in postoperativ nausea and vomiting. |
|
E.5.1.1 | 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. |
|
E.5.2 | 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) |
|
E.5.2.1 | 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. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The trial ends when all included patients has finished the follow-up period. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |