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

• ClinicalTrials.gov Identifier: NCT01170780
• Recruitment Status: Completed
• First Posted: July 27, 2010
• Last Update Posted: January 31, 2012
• Sponsor: Mette Astrup Madsen
• Information provided by (Responsible Party): Mette Astrup Madsen, Zealand University Hospital

Tracking Information

• First Submitted Date: July 26, 2010
• First Posted Date: July 27, 2010
• Last Update Posted Date: January 31, 2012
• Study Start Date: August 2010
• Actual Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 26, 2010)

pain during coughing [ Time Frame: day 1 ]

Assessed with visual analog scale (VAS 0-100 mm)

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (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 (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: Dexamethasone Versus Placebo in Optimizing the Postoperative Period After Laparoscopic Inguinal Hernia Repair
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Prevention

Condition

• Inguinal Hernia
• Femoral Hernia

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 26, 2010): 80
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: August 2011
• Actual Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 85 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT01170780
• Other Study ID Numbers: dx3
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Mette Astrup Madsen, Zealand University Hospital
• Study Sponsor: Mette Astrup Madsen
• Collaborators: Not Provided

Investigators

• 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