Study Results
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Basic Information
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NOT_YET_RECRUITING
NA
3352 participants
INTERVENTIONAL
2024-10-01
2026-04-01
Brief Summary
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Objective: Evaluate the non-inferiority of omitting antibiotic prophylaxis in MBS. Compare postoperative outcomes between Group A (no antibiotics) and Group B (standard antibiotic care) to determine if omission increases complications, particularly wound infections.
Study Design: Randomized controlled trial (RCT), double-blind.
Study Population: Patients with obesity eligible for MBS.
Intervention:
* Group A (No Antibiotic Prophylaxis): Undergo MBS without antibiotics to test safety regarding postoperative complications, focusing on surgical site infections (SSIs).
* Group B (Standard Antibiotic Prophylaxis): Receive standard one-time antibiotics before incision.
Main Study Parameters/Endpoints: Compare the incidence of incisional and organ/space SSIs within six weeks post-surgery between Group A and Group B to determine if omitting antibiotics affects infection rates.
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Detailed Description
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Rationale:
1. Cost-Effectiveness: Reducing antibiotic use could lower surgical costs.
2. Resource Utilization: Simplifying protocols save hospital resources.
3. Antibiotic Resistance: Reducing use helps combat resistant bacteria.
4. Adverse Reactions: Fewer antibiotics may reduce side effects.
Risk Assessment:
1. Increased Infection Rates: Monitor SSI and organ/space SSI rates closely.
2. Anastomotic Leaks and Reoperations: Assess the impact on leaks and operations.
3. Readmissions and Postoperative Interventions: Evaluate the effect on readmission and intervention rates.
Group Relatedness:
Comparing groups with and without antibiotics provides evi-dence-based insights into the safety of modifying standard practices to optimize health outcomes and resource use.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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NACL0.9%
Group A will receive 100 ml NACL0.9% without any antibiotics in it.
NACL 0.9% 100 ml
receive 100 ml NACL0.9% without any antibiotics in it.
Cefazolin +Metronidazole
Group B will receive 2000 mg of Cefazolin and 500 mg of Metronidazole IV dissolved in 100 ml NACL0.9%. Both antibiotics will be administered at least 30 minutes before surgery to ensure adequate tissue concentrations at the time of incision.
2000 mg of Cefazolin
receive 2000 mg of Cefazolin and 500 mg of Metronidazole IV dissolved in 100 ml NACL0.9%.
500 mg of Metronidazole IV
receive 2000 mg of Cefazolin and 500 mg of Metronidazole IV dissolved in 100 ml NACL0.9%.
Interventions
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2000 mg of Cefazolin
receive 2000 mg of Cefazolin and 500 mg of Metronidazole IV dissolved in 100 ml NACL0.9%.
500 mg of Metronidazole IV
receive 2000 mg of Cefazolin and 500 mg of Metronidazole IV dissolved in 100 ml NACL0.9%.
NACL 0.9% 100 ml
receive 100 ml NACL0.9% without any antibiotics in it.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with a history of endocarditis require prophylactic antibiotics.
* Patients with known severe allergies to antibiotics.
* Patients with active infections or recently treated with antibiotics (within the last 30 days).
* Patients with compromised immune systems, including those with HIV/AIDS or undergoing chemotherapy.
* Patients with chronic liver or kidney disease.
* Patients with uncontrolled diabetes (HbA1c \> 9%).
* Patients with a history of previous metabolic bariatric surgery.
* Pregnant or breastfeeding women.
* Patients with any other medical condition that, in the opinion of the investigator, would compromise the patient's safety or the study's integrity.
18 Years
70 Years
ALL
Yes
Sponsors
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General Committee of Teaching Hospitals and Institutes, Egypt
OTHER_GOV
Responsible Party
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Mohamed Hany Ashour
head of bariatric surgery
Locations
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Madina Women's Hospital
Alexandria, , Egypt
WeightWorks clinics
Amersfoort, Utrecht, Netherlands
Countries
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Facility Contacts
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References
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CDC antimicrobial resistance. Available from: https://www.cdc.gov/drugresistance/about.html
Aktas A, Kayaalp C, Gunes O, Kirkil C, Tardu A, Aydin MC, Bag YM, Cayci HM, Arslan U, Sumer F, Aygen E. Surgical Site Infections after Laparoscopic Bariatric Surgery: Is Routine Antibiotic Prophylaxis Required? Surg Infect (Larchmt). 2021 Sep;22(7):705-712. doi: 10.1089/sur.2020.426. Epub 2021 Jan 8.
Dang JT, Tran C, Switzer N, Delisle M, Laffin M, Madsen K, Birch DW, Karmali S. Predicting surgical site infections following laparoscopic bariatric surgery: development of the BariWound tool using the MBSAQIP database. Surg Endosc. 2020 Apr;34(4):1802-1811. doi: 10.1007/s00464-019-06932-6. Epub 2019 Jun 24.
Shope TR, Cooney RN, McLeod J, Miller CA, Haluck RS. Early results after laparoscopic gastric bypass: EEA vs GIA stapled gastrojejunal anastomosis. Obes Surg. 2003 Jun;13(3):355-9. doi: 10.1381/096089203765887651.
Alasfar F, Sabnis A, Liu R, Chand B. Reduction of circular stapler-related wound infection in patients undergoing laparoscopic Roux-en-Y gastric bypass, Cleveland clinic technique. Obes Surg. 2010 Feb;20(2):168-72. doi: 10.1007/s11695-008-9708-3. Epub 2008 Oct 7.
Schauer PR, Ikramuddin S, Gourash W, Ramanathan R, Luketich J. Outcomes after laparoscopic Roux-en-Y gastric bypass for morbid obesity. Ann Surg. 2000 Oct;232(4):515-29. doi: 10.1097/00000658-200010000-00007.
Finks JF, Carlin A, Share D, O'Reilly A, Fan Z, Birkmeyer J, Birkmeyer N; Michigan Bariatric Surgery Collaborative from the Michigan Surgical Collaborative for Outcomes Research Evaluation. Effect of surgical techniques on clinical outcomes after laparoscopic gastric bypass--results from the Michigan Bariatric Surgery Collaborative. Surg Obes Relat Dis. 2011 May-Jun;7(3):284-9. doi: 10.1016/j.soard.2010.10.004. Epub 2010 Oct 16.
Mangram AJ, Horan TC, Pearson ML, Silver LC. Guideline for Prevention of Surgical Site Infection, 1999. 1999;27.
Bratzler DW, Dellinger EP, Olsen KM, Perl TM, Auwaerter PG, Bolon MK, Fish DN, Napolitano LM, Sawyer RG, Slain D, Steinberg JP, Weinstein RA; American Society of Health-System Pharmacists (ASHP); Infectious Diseases Society of America (IDSA); Surgical Infection Society (SIS); Society for Healthcare Epidemiology of America (SHEA). Clinical practice guidelines for antimicrobial prophylaxis in surgery. Surg Infect (Larchmt). 2013 Feb;14(1):73-156. doi: 10.1089/sur.2013.9999. Epub 2013 Mar 5. No abstract available.
Anderson DJ, Podgorny K, Berrios-Torres SI, Bratzler DW, Dellinger EP, Greene L, Nyquist AC, Saiman L, Yokoe DS, Maragakis LL, Kaye KS. Strategies to prevent surgical site infections in acute care hospitals: 2014 update. Infect Control Hosp Epidemiol. 2014 Sep;35 Suppl 2:S66-88. doi: 10.1017/s0899823x00193869. No abstract available.
De Luca M, Angrisani L, Himpens J, Busetto L, Scopinaro N, Weiner R, Sartori A, Stier C, Lakdawala M, Bhasker AG, Buchwald H, Dixon J, Chiappetta S, Kolberg HC, Fruhbeck G, Sarwer DB, Suter M, Soricelli E, Bluher M, Vilallonga R, Sharma A, Shikora S. Indications for Surgery for Obesity and Weight-Related Diseases: Position Statements from the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO). Obes Surg. 2016 Aug;26(8):1659-96. doi: 10.1007/s11695-016-2271-4. No abstract available.
Eisenberg D, Shikora SA, Aarts E, Aminian A, Angrisani L, Cohen RV, de Luca M, Faria SL, Goodpaster KPS, Haddad A, Himpens JM, Kow L, Kurian M, Loi K, Mahawar K, Nimeri A, O'Kane M, Papasavas PK, Ponce J, Pratt JSA, Rogers AM, Steele KE, Suter M, Kothari SN. 2022 American Society of Metabolic and Bariatric Surgery (ASMBS) and International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) Indications for Metabolic and Bariatric Surgery. Obes Surg. 2023 Jan;33(1):3-14. doi: 10.1007/s11695-022-06332-1.
Joint Task Force on Practice Parameters; American Academy of Allergy, Asthma and Immunology; American College of Allergy, Asthma and Immunology; Joint Council of Allergy, Asthma and Immunology. Drug allergy: an updated practice parameter. Ann Allergy Asthma Immunol. 2010 Oct;105(4):259-273. doi: 10.1016/j.anai.2010.08.002.
Jourdan A, Sangha B, Kim E, Nawaz S, Malik V, Vij R, Sekhsaria S. Antibiotic hypersensitivity and adverse reactions: management and implications in clinical practice. Allergy Asthma Clin Immunol. 2020 Jan 21;16:6. doi: 10.1186/s13223-020-0402-x. eCollection 2020.
WHO antimicrobial resistance. Available from: https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance
Mokrani D, Chommeloux J, Pineton de Chambrun M, Hekimian G, Luyt CE. Antibiotic stewardship in the ICU: time to shift into overdrive. Ann Intensive Care. 2023 May 6;13(1):39. doi: 10.1186/s13613-023-01134-9.
Other Identifiers
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AB-BAR-2024
Identifier Type: -
Identifier Source: org_study_id
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