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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02083939
Recruitment Status : Terminated (Recruitment failed)
First Posted : March 11, 2014
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
Dr. Danny Rosin, MD, Sheba Medical Center

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.

Condition or disease
Hernia, Inguinal

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.

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Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prophylactic Antibiotic Treatment for Laparoscopic Inguinal Hernia Mesh Repair: Necessary or Not?
Study Start Date : March 2014
Actual Primary Completion Date : September 17, 2019
Actual Study Completion Date : September 17, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics Hernia

Group/Cohort
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



Primary Outcome Measures :
  1. Incidence of surgical site infection [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02083939


Locations
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Israel
Sheba Medical Center
Tel Hashomer, Israel
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Danny Rosin, MD Sheba Medical Center
Publications:
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Responsible Party: Dr. Danny Rosin, MD, Attending Surgeon, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02083939    
Other Study ID Numbers: SHEBA-12-9550-DR-CTIL
First Posted: March 11, 2014    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Keywords provided by Dr. Danny Rosin, MD, Sheba Medical Center:
Inguinal hernia
Mesh repair
Prophylactic Antibiotics
Herniorrhaphy
Laparoscopic Inguinal Hernia Repair
Additional relevant MeSH terms:
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Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal