Antibiotic Prophylaxis in Metabolic Bariatric Surgery

Summary

SUMMARY Rationale: Prophylactic antibiotics in laparoscopic surgeries, including Metabolic Bariatric Surgery (MBS), are routinely provided to reduce postoperative infections, especially at wound incision sites. However, since incisional wound infections in laparoscopic MBS are rare and morbidity is very low, the benefit of antibiotic prophylaxis is questionable. 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.

Timeline

Start

2024-10-01

Primary completion

2025-12-01

Completion

2026-04-01

Publications

• Background CDC antimicrobial resistance. Available from: https://www.cdc.gov/drugresistance/about.html
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results Mangram AJ, Horan TC, Pearson ML, Silver LC, Jarvis WR. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78; quiz 279-80. doi: 10.1086/501620. No abstract available.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results WHO antimicrobial resistance. Available from: https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance
• Results 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.

Drugs

Indications

No indication recorded.