Text Size

Dexamethasone Versus Placebo in Optimizing the Postoperative Period After Laparoscopic Inguinal Hernia Repair

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mette Astrup Madsen, University Hospital Koge
ClinicalTrials.gov Identifier:
NCT01170780
First received: July 26, 2010
Last updated: January 26, 2012
Last verified: January 2012
History of Changes

July 26, 2010
January 26, 2012
August 2010
June 2011   (final data collection date for primary outcome measure)
pain during coughing [ Time Frame: day 1 ] [ Designated as safety issue: No ]
Assessed with visual analog scale (VAS 0-100 mm)
Same as current
Complete list of historical versions of study NCT01170780 on ClinicalTrials.gov Archive Site
  • pain during coughing [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    Assessed with VAS
  • pain at rest [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    Assessed with VAS
  • convalescence [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Registration of number of days after operation before returning to work and recreational activities.
  • pain at rest [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    Assessed with verbal rating scale (VRS:no pain, mild pain, severe pain, worst thinkable pain)
  • nausea [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    Assessed with verbal rating scale (VRS: no nausea, mild nausea, severe nausea, worst thinkable nausea)
  • vomiting [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    yes/no question. If yes, how many times have you been vomiting?
  • discomfort [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    Assessed with visual analog scale (VAS, 0-100 mm)
  • fatigue [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    Assessed with numeric rating scale (NRS, 1-10)
  • pain during coughing [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    Assessed with VAS
  • pain at rest [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    Assessed with VAS
  • convalescence [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    Registration of number of days after operation before returning to work and recreational activities.
  • pain at rest [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    Assessed with verbal rating scale (VRS:no pain, mild pain, severe pain, worst thinkable pain)
  • nausea [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    Assessed with verbal rating scale (VRS: no nausea, mild nausea, severe nausea, worst thinkable nausea)
  • vomiting [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    yes/no question. If yes, how many times have you been vomiting?
  • general well-being [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    Assessed with visual analog scale (VAS, 0-100 mm)
  • fatigue [ Time Frame: 4 days ] [ Designated as safety issue: No ]
    Assessed with numeric rating scale (NRS, 1-10)
Not Provided
Not Provided
 
Dexamethasone Versus Placebo in Optimizing the Postoperative Period After Laparoscopic Inguinal Hernia Repair
Dexamethasone Versus Placebo in Optimizing the Postoperative Period After Laparoscopic Inguinal Hernia Repair

Does corticosteroid (dexamethasone) have an effect on the postoperative period after laparoscopic hernia repair, when it comes to pain, postoperative nausea and vomiting and convalescence. This randomized, double-blinded study compares dexamethasone versus placebo. The patients are recommended one day of convalescence. The medicine or placebo is given before operation. The patients fill out questionnaire before operation and three hours after operation and in the following three days. The patients also register when they return to normal activities and work.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Inguinal Hernia
  • Femoral Hernia
  • Drug: Dexamethasone
    single use of dexamethasone IV 8 mg/2 ml
    Other Name: Fortecontin
  • Drug: Saline
    2 ml IV
    Other Name: Natriumchlorid, B. Braun 9 mg/ml
  • Placebo Comparator: Placebo
    Saline
    Intervention: Drug: Saline
  • Active Comparator: Dexamethasone
    Corticosteroid (Fortecontin 8 mg)
    Intervention: Drug: Dexamethasone
Tolver MA, Strandfelt P, Bryld EB, Rosenberg J, Bisgaard T. Randomized clinical trial of dexamethasone versus placebo in laparoscopic inguinal hernia repair. Br J Surg. 2012 Oct;99(10):1374-80. doi: 10.1002/bjs.8876.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
August 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients planned for elective laparoscopic hernia repair (TAPP)
  • Unilateral inguinal or femoral hernia
  • ASA class I-II
  • Read and speak Danish

Exclusion Criteria:

  • Acute hernia operation
  • Operation for other hernias with mesh during the same procedure
  • Endocrine disease (diabetes, adrenal insufficiency etc.)
  • fever/infection within the first 10 days before operation
  • Poor compliance
  • No signed consent form
  • Daily intake of opioids or anxiolytic drugs
  • Manic episodes
  • Use medicine against glaucoma
  • Use thiazide or loop diuretics
  • Vaccination within the last 14 days
Male
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01170780
dx3
Yes
Mette Astrup Madsen, University Hospital Koge
Mette Astrup Madsen
Not Provided
Principal Investigator: Mette A Tolver, M.D. University Hospital Koege
Principal Investigator: Thue Bisgaard, M.D. DMSc University Hospital Koege
University Hospital Koge
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP