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临床试验/NCT04762381
NCT04762381已完成不适用

Effect of 24 mg Dexamethasone Preoperatively on Surgical Stress, Pain and Recovery in Robotic-assisted Laparoscopic Hysterectomy

Herning Hospital1 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2022年6月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
109
试验地点
1
主要终点
level of c-reactive protein (CRP)

研究概览

简要总结

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 appropriate way

详细描述

Background Robotic operations in gynecology is one of the fastest growing fields in applied robotic technology.

In Denmark 4000 hysterectomies are performed each year on benign indications and minimal invasive techniques has risen from 35 to 80%. These operations consist of vaginal, laparoscopic assisted und the latest robotic assisted hysterectomy. Hysterectomy and prostate operations are the most common robotic assisted operations as an alternative to conventional laparoscopy.

Robotic surgery on benign indications in gynecology is still a discussion on the cost vs. benefit due to increased cost and lack of evidence on superiority in surgical outcome compared to conventional laparoscopy. For minimal invasive surgery is but a part of a complex series of treatment in a strategy, the so-called multi-modal regimen (1-7,16). By this, the day of discharge has dramatically decreased without compromising safety during surgery and postoperative recovery. However, not all single elements are proven for efficacy, let alone the specific targets for effect (16).

To further improve the overall outcome of surgery the surgical stress response are investigated, which includes inflammatory components and are of importance of postoperative pain and recovery (8,9,16). Here amongst others, glucocorticoids have proven to relieve pain in a number of procedures, applied in general surgery on colon, gallbladder, and breast, in orthopedic surgery on knee and breast surgery, and in gynecology, too, in laparoscopic hysterectomy (1-10,15,16). The dose of steroid to provide significant analgesic effect is, at least, dexamethasone of 0.1-0.2 mg/kg or 15 mg, which is substantiated in some reduction in inflammatory response (7,15,16). Glucocorticoids are known for analgesic, opioid-sparing and antiemetic effects but procedure-specific outcome are lacking. Similarly, the specific anti-inflammatory and sites of surgical stress-related responses are not well elucidated.

Aim The PhD study evaluate the effects of a single dose of steroid on acute postoperative stress response and pain after hysterectomy. The evaluation is on clinical relevant outcome that directly benefit the patients. We will measure surgical stress by c-reactive protein and other inflammatory markers based on transcriptional profiling, register pain and medication needed during hospital stay and after discharge, and when work and sexual function could be resumed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

盲法说明

Blinded, results enteree into RedCap, logged and masked for participants

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Meno-metrorrhagia,
  • dysmenorrhea,
  • dysplasia,
  • dysmenorrhea,
  • ability in Danish writing

排除标准

  • current treatment with glucocorticoids, opioids and NSAID analgesics,
  • diabetes,
  • current treatment of malignant disease,
  • renal or hepatic disease,
  • unable to communicate in Danish language.

研究组 & 干预措施

Dexamethasone

Active Comparator

24 mg dexamethasone as single dose intravenously peroperatively

干预措施: Dexamethasone phosphate (Drug)

Placebo

Placebo Comparator

saline infusion intravenously in a single dose

干预措施: Placebo (Other)

结局指标

主要结局

level of c-reactive protein (CRP)

时间窗: 0-36 hours

c-reactive protein measured in mg/l

次要结局

  • level of IL-6(0-36 hours)
  • Number of steps count measured by pedometer(0-14 days)
  • Leucucytes(0-36 hours)
  • mRNA(0-36 hours)
  • Incontinence(0-14 days)
  • Sexual function(0-14 days)
  • work life checklist(0-14 days)

研究者

发起方
Herning Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Finn Lauszus

Associate Professor

Hospital of Southern Jutland

研究点 (1)

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