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.

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Status: Completed

Conditions: Surgical Site Infection

Treatments: Procedure: MESH WITHOUT OMEGA-3; Procedure: MESH WHIT OMEGA-3

Study type: Observational

Funder types: Other

Identifiers

NCT04345809

AGHO MYL PRELIMI

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 95 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

95 participants in 2 patient groups

GROUP A. MESH WITH OMEGA-3

Description:

Group A - 6.4-cm diameter circular prosthesis C-QUR V-Patch with an omega-3 coating

Treatment:

Procedure: MESH WHIT OMEGA-3

GROUP B. MESH WITHOUT OMEGA-3

Description:

Group B - 6.4-cm diameter circular prosthesis BARD Hernia Patch , without omega-3 in its composition

Treatment:

Procedure: MESH WITHOUT OMEGA-3