Port-site Hernia Clinical Trial
| Verified date | February 2013 |
| Source | Hospital General Universitario Elche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Spain: Ethics Committee |
| Study type | Interventional |
The incidence of port-site hernia in patients with risk factors (obesity, elderly, diabetes and lung disorders) can be reduced by the use of a prophylactic mesh in the closure of umbilical port site.
| Status | Completed |
| Enrollment | 106 |
| Est. completion date | December 2012 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 90 Years |
| Eligibility |
Inclusion Criteria: - Age > 65 years - BMI > 30 Kg/m2 - Diabetes mellitus - Lung disease - Elective laparoscopic cholecystectomy Exclusion Criteria: - Umbilical hernia - Previous laparotomy - Conversion to open procedure - Loss during the follow up |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital general Universitario de Elche | Elche | Alicante |
| Lead Sponsor | Collaborator |
|---|---|
| Hospital General Universitario Elche |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Incidence of port-site hernia | Comparison of incidence of port-site hernia between patiensts with and without prophylactic mesh placement | 12 months | Yes |
| Secondary | Postoperative pain | Evaluation of different pain perception in patients with and without prophylactic mesh placement, determined in the postoperative course and at 1, 6 and 12 months after surgery | 12 months | Yes |