Hernia, InguinalNCT02083939
Prophylactic Antibiotic Treatment for Laparoscopic Inguinal Hernia Mesh Repair: Necessary or Not?
An observational study of Hernia, Inguinal, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hernia, Inguinal
- How many people
- 5 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2014to 17 Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Elective laparoscopic inguinal hernia repair, unilateral or bilateral
Who cannot join
- Those requiring antibiotics for the surgery;
- Those patients who have experienced surgical site infections from previous surgeries
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Keywords
- Inguinal hernia, Mesh repair, Prophylactic Antibiotics, Herniorrhaphy, Laparoscopic Inguinal Hernia Repair
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2014 (estimated)
- Study startMar 2014
- Primary completion17 Sep 2019
- Study completion17 Sep 2019
Why it stopped: Recruitment failed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hernia, InguinalStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Danny Rosin, MD, Sheba Medical Center
- Investigators
- Danny Rosin, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02083939
- Sponsor's protocol ID
- SHEBA-12-9550-DR-CTIL
- Status last verified
- Jun 2020
- First submitted
- 8 Mar 2014
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23052809Shah 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.
PubMed 23063084Wang 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.
PubMed 24120711
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Antibiotic Treatment for Laparoscopic Inguinal Hernia Mesh Repair: Necessary or Not?
- ClinicalTrials.gov ID
- NCT02083939
- Acronym / sponsor ID
- SHEBA-12-9550-DR-CTIL
- Conditions
- Hernia, Inguinal
- Keywords
- Inguinal hernia, Mesh repair, Prophylactic Antibiotics, Herniorrhaphy, Laparoscopic Inguinal Hernia Repair
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment failed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Mar 2014
- Primary completion
- 17 Sep 2019 (actual)
- Study completion
- 17 Sep 2019 (actual)
- First posted
- 11 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Elective laparoscopic inguinal hernia repair, unilateral or bilateral
Key exclusion criteria (2 listed)
- Those requiring antibiotics for the surgery;
- Those patients who have experienced surgical site infections from previous surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Recruitment failed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Background: PubMed 23052809Cabaluna 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.
- Background: PubMed 23063084Shah 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.
- Background: PubMed 24120711Wang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danny Rosin, MD principal investigator
Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hernia, Inguinal, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Recruitment failed). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of surgical site infection (time frame: One year post-operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02083939, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.