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Comparing titanium-coated lightweight mesh versus medium-weight composite mesh for laparoscopic hernia repair

Randomized clinical trial of laparoscopic hernia repair comparing titanium-coated lightweight mesh versus mediumweight composite mesh

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN88233610
Enrollment
150
Registered
2011-10-07
Start date
2005-01-01
Completion date
Unknown
Last updated
2016-11-07

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

Conditions

Incisional hernia Digestive System Other abdominal hernia

Interventions

Group A: laparoscopic hernia repair with lightweight (titanium-coated). Patients n=51 Group B: laparoscopic hernia repair with heavyweight (collagen-polyester composite), patients n=51

Sponsors

Morales Meseguer Hospital (Spain)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients who were at least 18 years old and diagnosed at the Abdominal Wall Unit of Morales Meseguer University Hospital of Murcia with an incisional hernia 1.1. In this study, incisional hernia was defined as any midline abdominal wall gap with a bulge in the area of a postoperative scar perceptible or palpable by clinical examination and imaging (localized between the xiphoid and pubic bone)

Exclusion criteria

Exclusion criteria: 1. Patients with non-midline hernias and a fascial defect greater than 10cm 2. Patients with incisional hernias repaired with a synthetic mesh 3. Those receiving corticosteroid therapy, radiotherapy or chemotherapy 4. Concurrent neoplasms 5. Proven mental illness or other circumstances that might compromise the patient?s cooperation as well as those who refused to give informed consent

Design outcomes

Primary

MeasureTime frame
1. Pain 1.1. Acute pain, defined as pain reported by a patient in the first 6 months after operation 1.2. Chronic pain, defined as pain that persisted for more than 12 months 1.3. Pain scores on a 10-cm visual analogue scale (VAS) were measured from 0 (no pain) to 10 (unbearable pain) 2. Recurrence, confirmed by clinical examination and computerised tomography (CT)

Secondary

MeasureTime frame
1. Morbidity 2. Operating time (minutes) 3. Hospital stay (days) 4. Need for oral analgesia (days) 5. The time it took to return to everyday activity (days). This period was defined as the time needed to be able to perform household activities, drive or walk painlessly. An increased analgesic requirement was defined as an analgesic intake which lasted for more than one day.

Countries

Spain

Outcome results

None listed

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