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.

NCT ID: NCT04345809

Last Updated: 2020-04-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 95 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-01-31

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.

Conditions

Surgical Site Infection

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

GROUP A. MESH WITH OMEGA-3

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

MESH WHIT OMEGA-3

Intervention Type: PROCEDURE

Mesh placement with Omega-3 at the umbilical trocar level after laparoscopic cholecystectomy in patients with risk factors for SSI and eventration.

GROUP B. MESH WITHOUT OMEGA-3

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

MESH WITHOUT OMEGA-3

Intervention Type: PROCEDURE

Mesh placement without Omega-3 at the umbilical trocar level after laparoscopic cholecystectomy in patients with risk factors for SSI and eventration.

Interventions

MESH 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.

Intervention Type: PROCEDURE

MESH 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.

Intervention Type: PROCEDURE

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.

• Conversion to laparotomy during the surgical procedure
• Non-acceptance of participation in the study by the patient
• Loss to follow-up.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Marta Bellón

FISABIO

Responsibility Role: PRINCIPAL_INVESTIGATOR

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Other Identifiers

AGHO MYL PRELIMI

Identifier Type: -

Identifier Source: org_study_id