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

Primary Purpose

Inguinal Hernia, Femoral Hernia

Status

Completed

Phase

Phase 3

Locations

Denmark

Study Type

Interventional

Intervention

Dexamethasone

Saline

About this trial

This is an interventional prevention trial for Inguinal Hernia focused on measuring Inguinal hernia, Transabdominal preperitoneal hernia repair, TAPP, Dexamethasone, Pain

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

University Hospital Koege

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Dexamethasone

Arm Description

Saline

Corticosteroid (Fortecontin 8 mg)

Outcomes

Primary Outcome Measures

pain during coughing

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

Secondary Outcome Measures

pain during coughing

Assessed with VAS

pain at rest

Assessed with VAS

convalescence

Registration of number of days after operation before returning to work and recreational activities.

pain at rest

Assessed with verbal rating scale (VRS:no pain, mild pain, severe pain, worst thinkable pain)

nausea

Assessed with verbal rating scale (VRS: no nausea, mild nausea, severe nausea, worst thinkable nausea)

vomiting

yes/no question. If yes, how many times have you been vomiting?

discomfort

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

fatigue

Assessed with numeric rating scale (NRS, 1-10)

Full Information

NCT ID

NCT01170780

First Posted

July 26, 2010

Last Updated

January 26, 2012

Sponsor

Mette Astrup Madsen

1. Study Identification

Unique Protocol Identification Number

NCT01170780

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Completed

Study Start Date

August 2010 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Mette Astrup Madsen

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Inguinal Hernia, Femoral Hernia

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Saline

Arm Title

Dexamethasone

Arm Type

Active Comparator

Arm Description

Corticosteroid (Fortecontin 8 mg)

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Other Intervention Name(s)

Fortecontin

Intervention Description

single use of dexamethasone IV 8 mg/2 ml

Intervention Type

Drug

Intervention Name(s)

Saline

Other Intervention Name(s)

Natriumchlorid, B. Braun 9 mg/ml

Intervention Description

2 ml IV

Primary Outcome Measure Information:

Title

pain during coughing

Description

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

Time Frame

day 1

Secondary Outcome Measure Information:

Title

pain during coughing

Description

Assessed with VAS

Time Frame

4 days

Title

pain at rest

Description

Assessed with VAS

Time Frame

4 days

Title

convalescence

Description

Registration of number of days after operation before returning to work and recreational activities.

Time Frame

1 month

Title

pain at rest

Description

Assessed with verbal rating scale (VRS:no pain, mild pain, severe pain, worst thinkable pain)

Time Frame

4 days

Title

nausea

Description

Assessed with verbal rating scale (VRS: no nausea, mild nausea, severe nausea, worst thinkable nausea)

Time Frame

2 days

Title

vomiting

Description

yes/no question. If yes, how many times have you been vomiting?

Time Frame

2 days

Title

discomfort

Description

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

Time Frame

4 days

Title

fatigue

Description

Assessed with numeric rating scale (NRS, 1-10)

Time Frame

4 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mette A Tolver, M.D.

Organizational Affiliation

University Hospital Koege

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Thue Bisgaard, M.D. DMSc

Organizational Affiliation

University Hospital Koege

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Hospital Koege

City

Koege

ZIP/Postal Code

4600

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

22961516

Citation

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.

Results Reference

derived

Learn more about this trial

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

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