Clinical trial NCT04345809: 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.
Official 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Site Infection
Lead sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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, included in general surgery consultations.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: SSI
timeFrame: 1 year
measure: TSIH
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
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