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

NCT02083939 | Terminated

• 1 other identifier: SHEBA-12-9550-DR-CTIL
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Hernia, Inguinal

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Antibiotic Prophylaxis

This cohort will receive antibiotic prophylaxis prior to the hernia repair

No Antibiotic Prophylaxis

This cohort will not receive antibiotic prophylaxis prior to the surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

100 patients undergoing elective hernia repair will be assigned randomly to the control group; 100 patients will be assigned to the treatment group.

You may qualify if:

• Elective laparoscopic inguinal hernia repair, unilateral or bilateral

You may not qualify if:

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

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, Israel

Location

Related 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.

  PMID: 23052809 BACKGROUND

• 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.

  PMID: 23063084 BACKGROUND

• 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.

  PMID: 24120711 BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Danny Rosin, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Surgeon

Study Record Dates

• First Submitted: March 8, 2014
• First Posted: March 11, 2014
• Study Start: March 1, 2014
• Primary Completion: September 17, 2019
• Study Completion: September 17, 2019
• Last Updated: June 4, 2020

Record last verified: 2020-06

Locations

IL (1)