Surgical Site Infection
Conditions
Brief summary
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
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.
Interventions
PROCEDUREMESH WHIT OMEGA-3
Mesh placement with Omega-3 at the umbilical trocar level after laparoscopic cholecystectomy in patients with risk factors for SSI and eventration.
PROCEDUREMESH WITHOUT OMEGA-3
Mesh placement without Omega-3 at the umbilical trocar level after laparoscopic cholecystectomy in patients with risk factors for SSI and eventration.
Sponsors
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SSI | 1 year | Surgical Site Infection. |
| TSIH | 1 year | Trocar site incisional hernia. |
Outcome results
None listed