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Can preoperative Dexamethasone optimise surgical outcomes after laparoscopic inguinal hernia repair. - dexa

Can preoperative Dexamethasone optimise surgical outcomes after laparoscopic inguinal hernia repair. - dexa

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-019899-77-DK
Enrollment
80
Registered
2010-05-18
Start date
2010-06-21
Completion date
Unknown
Last updated
2021-04-19

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

Conditions

Postoperative pain, nausea, vomiting, general well-being and convalescence after laparoscopic groin hernia repair. MedDRA version: 12.1 Level: LLT Classification code 10019917 Term: Hernia inguinal MedDRA version: 12.1 Level: LLT Classification code 10054711 Term: Postoperative pain MedDRA version: 12.1 Level: LLT Classification code 10036901 Term: Prophylaxis against postoperative nausea and vomiting MedDRA version: 12.1 Level: LLT Classification code 10016256 Term: Fatigue

Interventions

Trade Name: Fortecontin Pharmaceutical Form: Solution for infusion CAS Number: 50-02-2 Other descriptive name: DEXAMETHASONE Concentration unit: mg milligram(s) Concentration type: equal Concentration

Sponsors

Mette Astrup Madsen
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: males 18-85 years elective laparoscopic groin hernia repair Unilateral ASA I-II Speak and write Danish 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Acute operation for groin hernia Poor compliance Endocrine disease (diabetes, adrenal insufficiens etc.) Fewer/signs of infection in the last 10 days before operation Patients treated with thiazides or loop diuretics Patients with manic episodes in history Daily preoperative continuous treatment (in the week before surgery) with psychotropic drugs of all kinds, opioids and anxiolytica Patients with complications (bladder or intestinal perforation, hospitalization in intensive department after surgery for any reason Conversion to open surgery Hypersensitivity to dexamethasone or other ingredients Patients who undergo surgery for another hernia with mesh under the same operation

Design outcomes

Primary

MeasureTime frame
Main Objective: Postoperative pain during coughing day 1;Secondary Objective: convalescence nausea vomiting general well-being fatigue;Primary end point(s): The primary endpoint is pain during coughing Day 1. Secondary examined the effect on general well-being, fatigue, convalescence, pain at rest and PONV.

Countries

Denmark

Outcome results

None listed

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