Dexamethasone and Robotic-assisted Hysterectomy

• Status: Not yet recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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, Il-6, cortisol, and creatinine kinase. 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 appropriate way

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Herning Hospital
• Collaborator: Hospital of Southern Jutland
• Treatments: Dexamethasone; Dexamethasone 21-phosphate; Glucocorticoids

Criteria

Inclusion Criteria:

• Meno-metrorrhagia,

• dysmenorrhea,

• fibroma,

• dysplasia,

• dysmenorrhea,

• ability in Danish writing

Exclusion Criteria:

• current treatment with glucocorticoids, opioids and NSAID analgesics,

• diabetes,

• current treatment of malignant disease,

• renal or hepatic disease,

• unable to communicate in Danish language.