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Dexamethasone and Robotic-assisted Hysterectomy

NCT04762381 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2024-06-04

No results posted yet for this study

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. 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

Conditions

  • Inflammatory Response
  • Pain, Postoperative
  • Nausea, Postoperative
  • Incontinence
  • Sexual Behavior

Interventions

DRUG

Dexamethasone phosphate

24 mg dexamethasone infused peroperatively

OTHER

Placebo

Saline

Sponsors & Collaborators

  • Hospital of Southern Jutland

    collaborator OTHER

  • Herning Hospital

    lead OTHER

Principal Investigators

  • Britta Frederiksen, PhD · Gyn. Dept. Aabenraa Hospital, Sygehus Sønderjylland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2024-02-06
Completion
2024-02-06

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04762381 on ClinicalTrials.gov