Condition category
Digestive System
Date applied
13/11/2007
Date assigned
14/01/2008
Last edited
15/09/2008
Prospective/Retrospective
Retrospectively 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

Dr Angelica Koch

ORCID ID

Contact details

Djurgardsg 58
Linkoping
582 29
Sweden

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Lightweight titanium-coated mesh gives a faster time of convalescence and return to work and normal activity compared to standard heavyweight mesh prolene.

Ethics approval

Ethics approval received from the Ethics Committee of (Forskningsetikkommitten) University Hospital on the 3rd December 2005 (ref: 03-428).

Study design

Randomised controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Primary unilateral inguinal hernia in men

Intervention

A tension free repair using the Lichtenstein technique is performed, with local anaesthetics administered into the wound peroperatively.The basic principle is one unit, one surgeon, one method, and two meshes (randomised):
1. Lightweight titanium-coated mesh
2. Heavyweight prolene mesh

All operations are done in the same outpatient clinic under general anaesthesia. The surgeon is highly specialised, performing more than 500 hernia repairs a year and has over 30 years of operative experience.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Short-term convalescence, is evaluated by using a validated questionnaire in form of a diary assessing postoperative symptoms and recovery at rest and some other activities, which the patients after completion return by mail. It includes Visual Analogue Scales (VAS) ranging from 0 (no pain) to 100 mm (worst imaginable pain) to estimate preoperative pain, and experienced pain on day 1, 2, 3, 4, and 8 weeks after the operation. It also includes questions about time to return to work and normal activity.

Secondary outcome measures

One-year follow-up results:
1. Testicular atrophy, recurrence and chronic pain and discomfort (VAS) are assessed at the clinical visit
2. Quality of life is assessed using the Short Health Scale (SHS), regarding the intensity of symptoms, how much worries they cause and how they affect daily life and general well-being

Overall trial start date

01/02/2004

Overall trial end date

30/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Men in the age from 20 to 75 years with an elective Lichtenstein repair of a unilateral primary inguinal hernia were eligible to participate in the study. The patients were recruited and had their surgery in a clinic specialised in elective out-patient operations.

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

300

Participant exclusion criteria

Patients who were unable to walk 500 metres or unlikely to participate in the follow up (for example owing to language difficulties) were excluded.

Recruitment start date

01/02/2004

Recruitment end date

30/06/2006

Locations

Countries of recruitment

Sweden

Trial participating centre

Djurgardsg 58
Linkoping
582 29
Sweden

Sponsor information

Organisation

State Health Care in Ostergotland County (Landstingen i Ostergotland) (Sweden)

Sponsor details

S:t Larsg 49 B
Linkoping
582 24
Sweden
+46 (0)13 222000
landstinget@lio.se

Sponsor type

Government

Website

http://www.lio.se

Funders

Funder type

Government

Funder name

State Health Care in Ostergotland County (Landstingen i Ostergotland) (Sweden)

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

Results in http://www.ncbi.nlm.nih.gov/pubmed/18763243

Publication citations

  1. Results

    Koch A, Bringman S, Myrelid P, Smeds S, Kald A, Randomized clinical trial of groin hernia repair with titanium-coated lightweight mesh compared with standard polypropylene mesh., Br J Surg, 2008, 95, 10, 1226-1231, doi: 10.1002/bjs.6325.

Additional files

Editorial Notes