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

NCT01170780 | Completed Phase 3 DMC

• 1 other identifier: dx3
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Inguinal Hernia; Femoral Hernia

Keywords

Inguinal hernia; Transabdominal preperitoneal hernia repair; TAPP; Dexamethasone; Pain

Outcome Measures

Primary Outcomes (1)

• pain during coughing

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

  day 1

Secondary Outcomes (8)

• pain during coughing

  4 days

• pain at rest

  4 days

• convalescence

  1 month

• pain at rest

  4 days

• nausea

  2 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Saline

Drug: Saline

Dexamethasone

ACTIVE COMPARATOR

Corticosteroid (Fortecontin 8 mg)

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

single use of dexamethasone IV 8 mg/2 ml

Also known as: Fortecontin

Dexamethasone

Saline DRUG

2 ml IV

Also known as: Natriumchlorid, B. Braun 9 mg/ml

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mette Astrup Madsen: lead

Study Sites (1)

University Hospital Koege

Koege, 4600, Denmark

Location

Related Publications (1)

• 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.

  PMID: 22961516 DERIVED

MeSH Terms

Conditions

Hernia, Inguinal; Hernia, Femoral; Pain

Interventions

Dexamethasone; Sodium Chloride

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Mette A Tolver, M.D.

  University Hospital Koege

  PRINCIPAL INVESTIGATOR

• Thue Bisgaard, M.D. DMSc

  University Hospital Koege

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: July 26, 2010
• First Posted: July 27, 2010
• Study Start: August 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: August 1, 2011
• Last Updated: August 26, 2024

Record last verified: 2024-08

Locations

DK (1)