Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04189107 |
| Other study ID # |
DexaCup |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
|
| Last updated |
|
| Start date |
August 18, 2020 |
| Est. completion date |
November 9, 2022 |
Study information
| Verified date |
March 2023 |
| Source |
Rigshospitalet, Denmark |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
1. Randomized double-blinded clinical trial assigning half of the participants to a
high-dose dexamethasone regimen while the other half will receive a low-dose
dexamethasone dosage and placebo in the first postoperative period.
2. A investigation of "Why in hospital?" following TORS. From the first postoperative day
until discharge reasons for continued hospitalization will be registered in order to
identify clinical and organizational factors contributing to hospitalization
3. An assessment of "Days Alive and Out of Hospital" following TORS. From the day of
surgery and the first 12 postoperative months all admissions to a hospital ward will be
registered along with admission reasons. Any death during the first 12 months will be
noted with a cause of death.
Description:
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:
1. To lower the patients pain intensity after the TORS procedure with an intensified
dexamethasone regimen.
2. To investigate the clinical and organizational factors contributing to hospitalization
after TORS, and with this knowledge to establish an optimized postoperative care
program.
3. To measure the efficiency and morbidity after TORS using DAOH as a descriptive
assessment 12 months postoperatively.
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.
- A routine surgical complications study will be performed and examine surgical
complications within the first 30 postoperative days.
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.
