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Dexamethasone and Robotic-assisted Hysterectomy

NCT04762381 · Herning Hospital · Updated 4 June 2024

What is being tested
Dexamethasone phosphate; Placebo
For
Inflammatory Response; Pain, Postoperative; Nausea, Postoperative; Incontinence; Sexual Behavior
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 18 years to 85 years. About 109 people. The full rules are on the registry page.
Where
Denmark
When
Starts or started 1 June 2022, ends 6 Feb 2024. Registered 21 Feb 2021.
Results
None posted yet.

In the researchers' words

Robotic-assisted hysterectomy is an alternative to laparoscopic surgery as part of a minimal invasive regimen. Several treatment strategies are followed to improve the overall outcome and minimize surgical stress. Glucocorticoids provide significant analgesic and antiemetic effects but its role in a fast-track, multi-modal setting is not settled when discharge is planned within 24-36 hours. This study will evaluate in a randomized trial the effect of a single dose of 24 mg dexamethasone on women undergoing robotic-assisted hysterectomy with regard to surgical stress measured by c-reactive protein as primary outcome and, further, other stress markers like white blood cells. The postoperative recovery will be registered in validated charts and questionnaires for pain and analgesic use, quality of recovery, incontinence, sexual and work life. Furthermore, in a sub-analysis, transcriptional profiling will be applied to explore, which parts of the innate and cellular immune system is activated to explore the mechanisms of surgical stress response. The hypothesis is that women undergoing robotic hysterectomy would benefit from peroperative glucocorticoid treatment on important life qualities like pain, fatigue, freedom of medications and resuming work and sexual activities. Further, future adjuvant peroperative regimens may be able to target the stress response in a more…
ClinicalTrials.gov, NCT04762381

Sites

  • Gyn. Dept.;Aabenraa Hospital, Sygehus SønderjyllandAabenraa, Denmark