Trials / Completed
CompletedNCT04345809
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.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 95 (actual)
- Sponsor
- Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana · Academic / Other
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2017-01-01
- Completion
- 2018-01-01
- First posted
- 2020-04-14
- Last updated
- 2020-04-14
Source: ClinicalTrials.gov record NCT04345809. Inclusion in this directory is not an endorsement.