ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Inguinal Hernia Femoral Hernia Drug: Dexamethasone Drug: Saline Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Dexamethasone Versus Placebo in Optimizing the Postoperative Period After Laparoscopic Inguinal Hernia Repair
Study Start Date : August 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Placebo Comparator: Placebo
Saline
 Drug: Saline
2 ml IV
Other Name: Natriumchlorid, B. Braun 9 mg/ml
Active Comparator: Dexamethasone
Corticosteroid (Fortecontin 8 mg)
 Drug: Dexamethasone
single use of dexamethasone IV 8 mg/2 ml
Other Name: Fortecontin


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. pain during coughing [ Time Frame: day 1 ]
    Assessed with visual analog scale (VAS 0-100 mm)


Secondary Outcome Measures :
  1. pain during coughing [ Time Frame: 4 days ]
    Assessed with VAS

  2. pain at rest [ Time Frame: 4 days ]
    Assessed with VAS

  3. convalescence [ Time Frame: 1 month ]
    Registration of number of days after operation before returning to work and recreational activities.

  4. pain at rest [ Time Frame: 4 days ]
    Assessed with verbal rating scale (VRS:no pain, mild pain, severe pain, worst thinkable pain)

  5. nausea [ Time Frame: 2 days ]
    Assessed with verbal rating scale (VRS: no nausea, mild nausea, severe nausea, worst thinkable nausea)

  6. vomiting [ Time Frame: 2 days ]
    yes/no question. If yes, how many times have you been vomiting?

  7. discomfort [ Time Frame: 4 days ]
    Assessed with visual analog scale (VAS, 0-100 mm)

  8. fatigue [ Time Frame: 4 days ]
    Assessed with numeric rating scale (NRS, 1-10)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01170780


Locations
Denmark
University Hospital Koege
Koege, Denmark, 4600
Sponsors and Collaborators
Mette Astrup Madsen
Investigators
Principal Investigator: Mette A Tolver, M.D. University Hospital Koege
Principal Investigator: Thue Bisgaard, M.D. DMSc University Hospital Koege
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Mette Astrup Madsen, M.D., Zealand University Hospital
ClinicalTrials.gov Identifier: NCT01170780     History of Changes
Other Study ID Numbers: dx3
First Posted: July 27, 2010    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012

Keywords provided by Mette Astrup Madsen, Zealand University Hospital:
Inguinal hernia
Transabdominal preperitoneal hernia repair
TAPP
Dexamethasone
Pain

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Hernia, Femoral
Pathological Conditions, Anatomical
Hernia, Abdominal
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action