Senior Consultant, PhD student
Karsten Kaiser
Gynecology Department
| Projekt styring | ||
| Projekt status | Open | |
| Data indsamlingsdatoer | ||
| Start | 30.05.2022 | |
| Slut | 01.05.2025 | |
Effect of 24 mg Dexamethasone Preoperatively on Surgical Stress, Pain and Recovery in Robotic-assisted Laparoscopic Hysterectomy
Short summary
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
Rationale
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
Description of the cohort
Included are women above 18 years of age with no cognitive disabilities who are having a robotic hysterectomy for benign indications: Meno-metrorrhagia, dysmenorrhea, fibroma, dysplasia, and ability in Danish writing Exclusion criteria are current treatment with glucocorticoids, opioids and NSAID analgesics, diabetes, current treatment of malignant disease, renal or hepatic disease, and unable to communicate in Danish language.
Data and biological material
The primary endpoint is reduction of postoperative c-reactive protein (crp) after robotic hysterectomy as an objective measurement of the stress amelioration by the given steroid. The rise postoperatively will be ascertained by two baseline measurements and every 4-6 hours after operation as long as the women is not discharged. The crp is not expected to be dependent on each operation team eagerness to perform well or the postoperative care to reach certain standards. As secondary outcome we register pain scores from baseline to 24 h and later on, the postoperative analgesics medication from baseline to discharge and later on, quality of recovery (QoR-15D) in the latest 24 hours (12). Further, after discharge incontinence (ICIQ-UI), start of sexual life (PISQ-12/31), inflammatory markers, and resumption to recreational and work life will be ascertained in a diary. The baseline and early acute postoperative pain scores (visual analog scale, VAS) at rest and at movement (0-4 h postoperatively), late acute postoperative pain scores (VAS) at rest and at movement (24 h postoperatively); and cumulative opioid consumption (up to 24 h) will be registered. A part of blood will be stored for analysis of the cellular inflammatory systems by NanoString to explore the innate system and cellular activation (19,20). NanoString has the capacity to demonstrate activation of immune-related genes in the bloodstream during inflammatory induction and highlight an exciting role of immune competent cell in linking peripheral inflammation with immune activation and possibly anti-nociception. NanoString methodology investigates gene expression and currently quantifies the expression of 770 genes by determining the amount of messenger RNA (mRNA). mRNA is the end-product of gene transcription and, therefore, allows the study of gene up-regulation.
Collaborating researchers and departments
Department of Surgery, Køge