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.

April 11, 2020 updated by: Marta Bellón, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

95

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GROUP A. MESH WITH OMEGA-3
Group A - 6.4-cm diameter circular prosthesis C-QUR V-Patch with an omega-3 coating
Procedure: 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.
GROUP B. MESH WITHOUT OMEGA-3
Group B - 6.4-cm diameter circular prosthesis BARD Hernia Patch , without omega-3 in its composition
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

April 11, 2020

First Submitted That Met QC Criteria

April 11, 2020

First Posted (Actual)

April 14, 2020

Study Record Updates

Last Update Posted (Actual)

April 14, 2020

Last Update Submitted That Met QC Criteria

April 11, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AGHO MYL PRELIMI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

All individual patient data may be used by other researchers in terms of advancing research in this field.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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