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

Phase 1

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

• Registration Number: EUCTR2010-019899-77-DK
• Lead Sponsor: Mette Astrup Madsen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-05-18
• Last Update Posted: 19 April 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 80

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified