E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postoperative pain following transoral robotic surgery |
Postoperativ smerte ved transoral robotkirurgi |
|
E.1.1.1 | Medical condition in easily understood language |
squamous cell carcinoma of unknown primary |
Karcinommetastase på halsen fra ukendt primær tumor |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Ear, nose and throat diseases [C09] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036236 |
E.1.2 | Term | Postoperative pain relief |
E.1.2 | System Organ Class | 100000004865 |
|
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 investigate the effect of high dose steroids on the postoperative pain level measured by self-assessed VAS during rest and swallowing following transoral robotic surgery |
At undersøge højdosis steroids effekt på det postoperative smerteniveau efter transoral robotkirurgi |
|
E.2.2 | Secondary objectives of the trial |
Length of stay, surgical complications, use of PRN pain medications, postoperative nausea and vomitting, unplanned readmissions, food intake consistensy, weight difference between admission and discharge, HPV status, location of a found primary tumor |
Indlæggelsesvarighed, kirurgiske komplikationer, brug af p.n. smertestillende medicin, postoperativ kvalme og opkast, ikke-planlagte genindlæggelser, konsistens af føde, vægtforskel mellem indlæggelse og udskrivelse, HPV status. placering af ved fund af primær tumor |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• 18 years or older • Ability to provide a written informed consent • ECOG/WHO performance status 0-2 • Squamous cell carcinoma of unknown primary • Booked for TORS based on radiologic and clinical assessment by the surgeon • Negative Urine HCG pregnancy test for women in the fertile age.
|
1. 18 år eller ældre
2. I stand til at afgive informeret samtykke
3. WHO/ECOG-performance status 0-2
4. Karcinommetastase på halsen fra ukendt primærtumor 5. Booket til transoral robot kirurgi baseret på radiologiske og kliniske fund vurderet ved operatør 6. Negativ urin-HCG for kvinder i den fertile alder
|
|
E.4 | Principal exclusion criteria |
• Serious medical comorbidities (ECOG/WHO performance status >2). Other contraindications to surgery • Distant metastasis • Active Herpes zoster • Previous head and neck cancer • Significant trismus, maximum inter-incisal opening 35mm • Insulin dependent diabetes • Allergy to glucocorticoids • Preoperative use of systemic glucocorticoids <90 days before the surgery • Preoperative use of biological anti-inflammatory medication <90 days before the surgery • Suspected active gastric ulcer by in the opinion of the investigator • Pregnancy/Breastfeeding |
1. Alvorlig medicinske komorbiditet (WHO-performance status >2) eller andre kontraindikationer i forhold til kirurgi.
2. Fjernmetastaser.
3. Tidligere hoved-hals kræft.
4. Trismus (nedsat mundåbning ≤ 35mm).
5. Insulin afhængig diabetes 6. Glukokortikoid allergi 7. Brug af systemisk glukokortikoid <90 dage før operation 8. Brug af biologisk anti-inflammatorisk medicin <90 dage før operation 9. Mistænkt aktivt mavesår, vurderet af inkluderende læge. 10. Aktiv herpes zoster 11. Graviditet/amning |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Self assessed Pain intensity on a visual analoge scale (VAS) |
Selvvurderet smerteniveau på visuel smerteskale (VAS) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
During hospitalization and until 14 days after the procedure |
Under indlæggelse og indtil 14 dage postoperativt |
|
E.5.2 | Secondary end point(s) |
• Length of hospitalization • Use of PRN pain medication • Postoperative bleeding (Any postoperative bleeding during the primary hospitalization) • Postoperative infection (Any postoperative infection during the primary hospitalization - Pneumonia must be verified by radiological examination) • Hyperglycemia (A preoperatively blood sugar sample will be performed. Blood sugar measurements will be obtained again at day 2 and 4) • Postoperative nausea and vomiting (Self-assessed and noted in the patient’s pain dairy) • Number of reoperations • Number of tracheotomy procedures (Peroperatively and postoperative during the first 30 days) • Unplanned readmission (Unplanned readmission to an department of otorhinolaryngology during the first 30 postoperative days ) • Time to feeding tube removal if placed (Measured in days from tube placement until removal stated by a medical doctor - Additional feeding tube placement during the first 30 days will be noted in the patient CRF and are collected from the electronic journal ) • Self-assessed food intake consistency during the first 14 days • Weight difference (Between admission weight and discharge weight)
|
Indlæggelsesvarighed Brug af p.n smertestillende Postoperativ blødning Postoperativ infektion Postoperativ hyperglykæni Selvvurderet Postoperativ kvalme og opkast Reoperation Tracheostomi Genindlæggelse Tid til NG-sonde fjernelse selvvurderet konsistens af fødeindtag Vægtforskel mellem indlæggelsesvægt og vægt ved udskrivelsen |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
During hospitalization and until 14 days postoperatively |
Under indlæggelsen og indtil 14 dag postoperativt |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | 3 |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |