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

Hernia, Inguinal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02083939
• Other study ID #: SHEBA-12-9550-DR-CTIL
• Status: Terminated
• Start date: March 2014
• Est. completion date: September 17, 2019

Study information

• Verified date: June 2020
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: September 17, 2019
• Est. primary completion date: September 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (3)

Cabaluna ND, Uy GB, Galicia RM, Cortez SC, Yray MD, Buckley BS. A randomized, double-blinded placebo-controlled clinical trial of the routine use of preoperative antibiotic prophylaxis in modified radical mastectomy. World J Surg. 2013 Jan;37(1):59-66. doi: 10.1007/s00268-012-1816-5. — View Citation

Shah JN, Maharjan SB, Paudyal S. Routine use of antibiotic prophylaxis in low-risk laparoscopic cholecystectomy is unnecessary: a randomized clinical trial. Asian J Surg. 2012 Oct;35(4):136-9. doi: 10.1016/j.asjsur.2012.06.011. Epub 2012 Aug 22. — View Citation

Wang J, Ji G, Yang Z, Xi M, Wu Y, Zhao P, Wang L, Yu W, Wen A. Prospective randomized, double-blind, placebo controlled trial to evaluate infection prevention in adult patients after tension-free inguinal hernia repair. Int J Clin Pharmacol Ther. 2013 Dec;51(12):924-31. doi: 10.5414/CP201877. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of surgical site infection	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.	One year post-operation