Glucocorticoids during robotoc-assisted hysterectomy

Phase 1

Conditions: robotic- assisted hysterectomy
Therapeutic area: Body processes [G] - Physical Phenomena [G01]

Registration Number: EUCTR2021-000874-28-DK

Lead Sponsor: Gyn.Dept, Aabenraa Hospital, Sygehus Sønderjylland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 100

Inclusion Criteria

women who are having a robotic hysterectomy for benign indications: Meno-metrorrhagia, dysmenorrhea, fibroma, dysplasia, dysmenorrhea, and ability in Danish writing

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Gucocorticoid treatment to amelirate surgical stress parameters;Secondary Objective: 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. ;Primary end point(s): 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. ;Timepoint(s) of evaluation of this end point: 24-48 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): other inflammatory markers based on transcriptional profiling, pain and the medication needed during hospital stay and after discharge, and when work and sexual function could be resumed.;Timepoint(s) of evaluation of this end point: Transcriptional factors: 2 days post surgery<br>Pain and medication before admittance by hosptal cahrst 24-28 hours<br>Pain, medication, work sexual function fours weeks after discharge by questionnaires and diary