Randomised controlled trial: groin hernia repair with titanium coated mesh compared to prolene mesh

ISRCTN	ISRCTN36979348
DOI	https://doi.org/10.1186/ISRCTN36979348
Protocol serial number	N/A
Sponsor	State Health Care in Ostergotland County (Landstingen i Ostergotland) (Sweden)
Funder	State Health Care in Ostergotland County (Landstingen i Ostergotland) (Sweden)

Submission date: 13/11/2007
Registration date: 14/01/2008
Last edited: 15/09/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Angelica Koch
Scientific

Djurgardsg 58
Linkoping
582 29
Sweden

Study information

Primary study design	Interventional
Study design	Randomised controlled clinical trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Ethics approval received from the Ethics Committee of (Forskningsetikkommitten) University Hospital on the 3rd December 2005 (ref: 03-428).
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	30/06/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Male
Target sample size at registration	300
Key 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.
Key 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.
Date of first enrolment	01/02/2004
Date of final enrolment	30/06/2006

Locations

Countries of recruitment

Sweden

Study participating centre

Djurgardsg 58

Linkoping
582 29
Sweden

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/10/2008		Yes	No