Prophylactic Antibiotic Treatment for Laparoscopic Inguinal Hernia Mesh Repair: Necessary or Not?

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02083939

Enrollment

Registered

2014-03-11

Start date

2014-03-31

Completion date

2019-09-17

Last updated

2020-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hernia, Inguinal

Keywords

Inguinal hernia, Mesh repair, Prophylactic Antibiotics, Herniorrhaphy, Laparoscopic Inguinal Hernia Repair

Brief summary

The purpose of this study is to find out whether it is necessary to prophylactically treat patients undergoing laparoscopic inguinal hernia repairs with antibiotics. Our hypothesis is that it is not necessary to pretreat patients with antibiotics if the operation is minimally invasive with a mesh placed at the defect.

Detailed description

The investigators plan to follow up at least 100 patients who did not receive antibiotics prior to their inguinal hernia repair and compare their outcome to 100 patients who did receive prophylaxis. The investigators mainly will be analyzing the incidence of surgical site infections as evidenced by swelling, redness, pain, warmth or other signs deemed by the surgeon.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Elective laparoscopic inguinal hernia repair, unilateral or bilateral

Exclusion criteria

* Those requiring antibiotics for the surgery; * Those patients who have experienced surgical site infections from previous surgeries

Design outcomes

Primary

Measure	Time frame	Description
Incidence of surgical site infection	One year post-operation	The investigators will interview the patient at one week, at one month, and at one year post-operation and assess for any signs of infection around the location of hernia repair.

Countries

Israel

Outcome results