Skip to content

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN36979348
Enrollment
300
Registered
2008-01-14
Start date
2004-02-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary unilateral inguinal hernia in men Digestive System Inguinal hernia

Interventions

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 tw

Sponsors

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

Eligibility

Sex/Gender
Male

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Sweden

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 4, 2026