Glucocorticoids during robotoc-assisted hysterectomy

Effect of 24 mg dexamethasone preoperatively on surgical stress, pain and recovery in robotic-assisted laparoscopic hysterectomy - Glucocorticoids during robotoc-assisted hysterectomy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000874-28-DK

Enrollment

100

Registered

2021-04-20

Start date

2021-07-08

Completion date

Unknown

Last updated

2024-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

robotic- assisted hysterectomy

Interventions

Trade Name: Dexavit Product Name: Dexavit Product Code: H02AB02 Pharmaceutical Form: Concentrate and solvent for solution for infusion INN or Proposed INN: Dexavit CAS Number: 312-93-6 Other descripti

Eligibility

Sex/Gender

All

Inclusion criteria

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: 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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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 Pain and medication before admittance by hosptal cahrst 24-28 hours Pain, medication, work sexual function fours weeks after discharge by questionnaires and diary	—

Measure

Time frame

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 Pain and medication before admittance by hosptal cahrst 24-28 hours Pain, medication, work sexual function fours weeks after discharge by questionnaires and diary

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Countries

Denmark

Contacts

Public ContactGyn Dept., Aabenraa Hopsital

Gyn. Dept. Aabenraa Hospital, Sygehus Sønderjylland

finn.lauszus@rsyd.dk004579972192

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026