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 |
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E.1.1.1 | Medical condition in easily understood language |
squamous cell carcinoma of unknown primary Obstructive sleep apnea |
Karcinommetastase på halsen fra ukendt primær tumor obstruktiv søvn apnø |
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E.1.1.2 | Therapeutic area | Diseases [C] - Ear, nose and throat diseases [C09] |
MedDRA Classification |
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 |
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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 |
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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 or obstructive sleep apnea • Booked for TORS based on radiologic and clinical assessment by the surgeon o TORS for obstructive sleep apnea must be preceded by a Drug-induced sleep endoscopy (DISE) examination • Negative Urine HCG pregnancy test for women in the fertile age.
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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 eller obstruktiv søvn apnø 5. Booket til transoral robot kirurgi baseret på radiologiske og kliniske fund vurderet ved operatør TORS til obstruktiv søvn apnø patienter skal være forudgået af DISE-undersøgelse 6. Negativ urin-HCG for kvinder i den fertile alder
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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 |
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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) |
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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 |
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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)
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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 |
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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 |
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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
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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 |