This trial is active, not recruiting.

Condition hernia, inguinal
Sponsor Sheba Medical Center
Start date March 2014
End date April 2016
Trial size 200 participants
Trial identifier NCT02083939, SHEBA-12-9550-DR-CTIL


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
This cohort will receive antibiotic prophylaxis prior to the hernia repair
This cohort will not receive antibiotic prophylaxis prior to the surgery

Primary Outcomes

Incidence of surgical site infection
time frame: One year post-operation

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Prophylactic Antibiotic Treatment for Laparoscopic Inguinal Hernia Mesh Repair: Necessary or Not?
Principal investigator Danny Rosin, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Sheba Medical Center.