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| Name | Class |
|---|---|
| Candys Foundation | UNKNOWN |
| Region Capital Denmark | OTHER |
| Odense University Hospital | OTHER |
| Aarhus University Hospital |
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This protocol investigates the effect of a high dose dexamethasone regimen in the treatment of postoperative pain following Transoral Robotic Surgery (TORS). The protocol consists of three substudies.
The morbidity after TORS has not yet been fully investigated, but a recent studies suggest that pain is one of the primary causes for unplanned readmission This issue has been investigated by Clayburgh D et al who found that a prolonged dexamethasone regime lowered the pain scores on day three after surgery. The patients treated with the prolonged dexamethasone regime also showed a significant improvement in the food consistency they were capable to swallow and had a shortened length of stay (LOS). Recently, a pilot-study showed, that an intensified dexamethasone regime among TORS patients reduced the pain level to that of a standard tonsillectomy. Besides an analgesic effect glucocorticoids furthermore poses an anti-inflammatory quality which can be used to lower the physiological stress and inflammatory response following surgery and may prevent organ dysfunctions and complications The analgesic effect of dexamethasone has been the topic of many clinical studies, and are well described in various surgical fields. However, the optimal dose and regime for glucocorticoids prescription has so far not been established. The evidence favoring one dosage regime and an optimal prescribed dose is restricted by the variance in the regimes used in various clinical trials and the fact that there is a need for clinical trial investigating steroids with pain as the primary endpoint Consequently, it is important to thoroughly investigate and optimize the analgesic regime after TORS.
Hospitalization So far when evaluating the long-term consequences of TORS, the main focus has been on oncological outcomes and quality of life with attention to functional outcomes, i.e. feeding tube dependency and dysphagia while the LOS following TORS and why the patient is hospitalized after the procedure have been sparsely studied.
The reason why TORS patients are still hospitalized after the procedure and which clinical and organizational factors contribute to the hospitalization have not yet been examined and understood but is highly relevant in order to understand and improve the postoperative care.
A method to assess the efficiency of a therapy have emerged from the cardiology field and is called Days Alive and Out of Hospital (DAOH). This has been used in investigations of heart failure patients and myocardial infarction patients. This outcome combines mortality and morbidity, and accounts for the number but also duration of several hospitalizations after the primary discharge.
DAOH has only sparse been used in the surgical field, and only in few studies in the cardiac surgery area. The measurement is a patient-centered outcome that provide better information to the patient and surgeon when planning surgery, and can be used for quality improvement studies since it accounts for effective and efficient care.
Therefore, the DAOH measurement applied to the evaluation of TORS treatment for SCCUP will benefit the insight in how the patient's life after treatment is affected.
The aims of this study comprising patients treated with TORS for SCCUP:
This project consists of four studies:
Study 1 - Corresponding to aim A. The investigators hypothesize that an intensified dexamethasone regime will lower patients' reported pain intensity following TORS. This will be investigated in a randomized (1:1) double-blinded clinical trial among SCCUP patients undergoing TORS and extrapolated to the entire TORS population.
Study 2 - Corresponding to aim B The investigators hypothesize that not much is known about the precise reasons for why patients are hospitalized following TORS. Hence, a prospective observational study regarding "why still in hospital after TORS?" will be conducted among all patients with SCCUP scheduled for TORS.
Study 3 - Corresponding to aim C The investigators hypothesize that TORS is an efficient procedure with a low morbidity. Hence, a prospective observational study regarding DAOH will be conducted among all SCCUP patients scheduled for TORS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | High dose Dexamethasone |
|
| Control | Placebo Comparator | Standard dexamethasone dosage and placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexamethasone | Drug | High-dose dexamethasone peroperative and postoperative on day 2 and 4 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported Pain intensity | Visual analog scale (VAS) ranging from 0-10. 0 being no pain and 10 being maximum pain. The patient will twice daily self-assess pain-intensity during both rest and activity (swallowing). The pain-intensity will be noted in a pain-diary | Postoperative day 1 until day 14 postoperatively |
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| Measure | Description | Time Frame |
|---|---|---|
| Why in hospital | A functional discharge criteria scheme will be used twice daily at 9 a.m. and 2 p.m. (± 2 hours) to decide whether the patient can be discharged. The scheme will be filled out by a doctor and/or nurse and used until discharge from the ward. This is an assessment of organizational and clinical factors contributing to hospitalization | Postoperative day 1 until discharge |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Otorhinolaryngology, Head and Neck Surgery & Audiology | Copenhagen | 2100 | Denmark |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| D006258 | Head and Neck Neoplasms |
| D009959 | Oropharyngeal Neoplasms |
| D009382 | Neoplasms, Unknown Primary |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| OTHER |
1:1 Randomization to either experimental or control treatment
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| Placebo | Drug | low dose dexamethasone peroperative and placebo postoperatively on day 2 and 4 |
|
|
| Days Alive and Out of Hospital | Days alive and out of hospital is a composite patient-centered endpoint. It is calculated by deducting the length of stay of the initial admission as well as any subsequently admissions and days after potential death from the total follow-up period. Days Alive and Out of Hospital will be investigated from the day of surgery with a 12 months follow-up period. | From the day of surgery and the first 12 postoperative months |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D011183 | Postoperative Complications |
| D010146 | Pain |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |