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

NCT ID: NCT02083939

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2019-09-17

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.

Conditions

Hernia, Inguinal

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Antibiotic Prophylaxis

This cohort will receive antibiotic prophylaxis prior to the hernia repair

No interventions assigned to this group

No Antibiotic Prophylaxis

This cohort will not receive antibiotic prophylaxis prior to the surgery

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Danny Rosin, MD

Attending Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Danny Rosin, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Locations

Sheba Medical Center

Tel Litwinsky, , Israel

Countries

Israel

References

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.

Reference Type: BACKGROUND

PMID: 23052809 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23063084 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24120711 (View on PubMed)

Other Identifiers

SHEBA-12-9550-DR-CTIL

Identifier Type: -

Identifier Source: org_study_id