Condition category
Digestive System
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
18/11/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof J. Jeekel

ORCID ID

Contact details

Erasmus Medical Centre
Department of General Surgery
Molewaterplein 40
Rotterdam
3015 GD
Netherlands
+31 (0)10 463 3718
j.jeekel@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR221

Study information

Scientific title

Acronym

Study hypothesis

Non-inferiority hypothesis: observation is not inferior to operation with respect to the mean of pain and discomfort during 3 years follow-up.

Ethics approval

Received from the local medical ethics committee

Study design

Multicentre, randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Hernia Inguinal

Intervention

1. Operation
2. No intervention, observational management of the inguinal hernia

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The mean of 4 pain/discomfort scores during a follow-up period of 3 years.

Secondary outcome measures

Quality adjusted life years (QALY) with quality weights measured with the EuroQol and in a sensitivity analysis with a transformed 36-item short form (SF-36) utility weight, medical and non-medical costs and event-free survival at 2 years.

Overall trial start date

01/01/2006

Overall trial end date

01/01/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Unilateral inguinal hernia
2. Males
3. Medial or lateral inguinal hernia
4. Aged greater than or equal to 50 years
5. Description I or II of pain or discomfort interfering with daily activity
6. Primary or recurrent inguinal hernia
7. Informed consent (addendum V)

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

800

Participant exclusion criteria

1. Gender: female
2. Bilateral inguinal hernia
3. Femoral hernia
4. Description III or IV of pain or discomfort interfering with daily activity
5. Acute hernia complication (bowel obstruction, incarceration, strangulation, peritonitis or perforation)
6. Patient classified as American Society of Anaesthesiologist Class 4
7. Scrotal hernia (cannot be corrected laparoscopically)
8. Patient is unable to speak Dutch
9. Physical activity: patient travels regularly during which professional medical help is not always accessible
10. Inguinal hernia not apparent during ultrasonography

Recruitment start date

01/01/2006

Recruitment end date

01/01/2011

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Centre
Rotterdam
3015 GD
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (Netherlands)

Sponsor details

Dr Molewaterplein 40/50
Rotterdam
3000 CA
Netherlands

Sponsor type

University/education

Website

http://www.erasmusmc.nl/

Funders

Funder type

Research organisation

Funder name

The Netherlands Organisation for Health Research and Development (ZonMw) (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes