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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01170780
Recruitment Status : Completed
First Posted : July 27, 2010
Last Update Posted : January 31, 2012
Sponsor:
Information provided by (Responsible Party):
Mette Astrup Madsen, Zealand University Hospital

Tracking Information
First Submitted Date  ICMJE July 26, 2010
First Posted Date  ICMJE July 27, 2010
Last Update Posted Date January 31, 2012
Study Start Date  ICMJE August 2010
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2010)
pain during coughing [ Time Frame: day 1 ]
Assessed with visual analog scale (VAS 0-100 mm)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2012)
  • pain during coughing [ Time Frame: 4 days ]
    Assessed with VAS
  • pain at rest [ Time Frame: 4 days ]
    Assessed with VAS
  • convalescence [ Time Frame: 1 month ]
    Registration of number of days after operation before returning to work and recreational activities.
  • pain at rest [ Time Frame: 4 days ]
    Assessed with verbal rating scale (VRS:no pain, mild pain, severe pain, worst thinkable pain)
  • nausea [ Time Frame: 2 days ]
    Assessed with verbal rating scale (VRS: no nausea, mild nausea, severe nausea, worst thinkable nausea)
  • vomiting [ Time Frame: 2 days ]
    yes/no question. If yes, how many times have you been vomiting?
  • discomfort [ Time Frame: 4 days ]
    Assessed with visual analog scale (VAS, 0-100 mm)
  • fatigue [ Time Frame: 4 days ]
    Assessed with numeric rating scale (NRS, 1-10)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2010)
  • pain during coughing [ Time Frame: 4 days ]
    Assessed with VAS
  • pain at rest [ Time Frame: 4 days ]
    Assessed with VAS
  • convalescence [ Time Frame: 1 month ]
    Registration of number of days after operation before returning to work and recreational activities.
  • pain at rest [ Time Frame: 4 days ]
    Assessed with verbal rating scale (VRS:no pain, mild pain, severe pain, worst thinkable pain)
  • nausea [ Time Frame: 2 days ]
    Assessed with verbal rating scale (VRS: no nausea, mild nausea, severe nausea, worst thinkable nausea)
  • vomiting [ Time Frame: 2 days ]
    yes/no question. If yes, how many times have you been vomiting?
  • general well-being [ Time Frame: 4 days ]
    Assessed with visual analog scale (VAS, 0-100 mm)
  • fatigue [ Time Frame: 4 days ]
    Assessed with numeric rating scale (NRS, 1-10)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexamethasone Versus Placebo in Optimizing the Postoperative Period After Laparoscopic Inguinal Hernia Repair
Official Title  ICMJE Dexamethasone Versus Placebo in Optimizing the Postoperative Period After Laparoscopic Inguinal Hernia Repair
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Inguinal Hernia
  • Femoral Hernia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Placebo
    Saline
    Intervention: Drug: Saline
  • Active Comparator: Dexamethasone
    Corticosteroid (Fortecontin 8 mg)
    Intervention: Drug: Dexamethasone
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 26, 2010)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01170780
Other Study ID Numbers  ICMJE dx3
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mette Astrup Madsen, Zealand University Hospital
Study Sponsor  ICMJE Mette Astrup Madsen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mette A Tolver, M.D. University Hospital Koege
Principal Investigator: Thue Bisgaard, M.D. DMSc University Hospital Koege
PRS Account Zealand University Hospital
Verification Date January 2012

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