Effect of Prophylactic Prosthesis Placement With Versus Without Omega-3 at the Umbilical Trocar Level on Surgical Site Infection and Herniation After Laparoscopic Cholecystectomy in Patients With Risk Factors.

Study Overview
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Brief Summary
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TITLE: Effect of prophylactic prosthesis placement with versus without omega-3 at the umbilical trocar level on surgical site infection and herniation after laparoscopic cholecystectomy in patients with risk factors. OBJECTIVE: To evaluate whether the placement of a synthetic prosthesis with omega-3 in its composition at the level of the umbilical trocar after laparoscopic cholecystectomy versus the placement of a synthetic umbilical prosthesis without omega-3 in its composition decreases the rate of surgical site infection (SSI) and trocar site hernia (TSH) in patients with risk factors for infection and herniation.

Detailed Description
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METHODS: A prospective study was conducted with 2 consecutive series of patients operated on for cholelithiasis who also had some of the following risk factors that increase the occurrence of SSI or TSH: BMI > 30 kg/m2, diabetes mellitus, age > 65 years and chronic obstructive pulmonary disease. A circular prosthesis with an omega-3 coating was placed in patients in group A, and a prosthesis without omega-3 in its composition was placed in patients in group B. The main variables evaluated were the occurrence of SSI and TSH.

Official Title
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Effect of Prophylactic Prosthesis Placement With Versus Without Omega-3 at the Umbilical Trocar Level on Surgical Site Infection and Herniation After Laparoscopic Cholecystectomy in Patients With Risk Factors.

Conditions
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Surgical Site Infection

Intervention / Treatment
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* Procedure: MESH WHIT OMEGA-3
* Procedure: MESH WITHOUT OMEGA-3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The included patients were between the ages of 18 and 90 years, underwent elective laparoscopic cholecystectomy for symptomatic cholelithiasis and had one of the following risk factors that increase the occurrence of SSI or TSIH: Obesity: with a body mass index (BMI) > 30 kg/m2. Diabetes Mellitus (insulin dependent or who take oral antidiabetic drugs), Age > 65 years and COPD treated with inhalers. Exclusion Criteria: Nonfulfillment of the inclusion criteria. Conversion to laparotomy during the surgical procedure Non-acceptance of participation in the study by the patient Loss to follow-up.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GROUP A. MESH WITH OMEGA-3<br>Group A - 6.4-cm diameter circular prosthesis C-QUR V-Patch with an omega-3 coating | Procedure: MESH WHIT OMEGA-3<br>* Mesh placement with Omega-3 at the umbilical trocar level after laparoscopic cholecystectomy in patients with risk factors for SSI and eventration.<br>|
| GROUP B. MESH WITHOUT OMEGA-3<br>Group B - 6.4-cm diameter circular prosthesis BARD Hernia Patch , without omega-3 in its composition | Procedure: MESH WITHOUT OMEGA-3<br>* Mesh placement without Omega-3 at the umbilical trocar level after laparoscopic cholecystectomy in patients with risk factors for SSI and eventration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SSI | Surgical Site Infection. | 1 year | 
| TSIH | Trocar site incisional hernia. | 1 year |