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

Completed

• Conditions: Incisional hernia; Digestive System; Other abdominal hernia

• Registration Number: ISRCTN88233610
• Lead Sponsor: Morales Meseguer Hospital (Spain)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-07
• Last Update Posted: 7 November 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1. Morbidity<br>2. Operating time (minutes)<br>3. Hospital stay (days)<br>4. Need for oral analgesia (days)<br>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.