Antibiotic Prophylaxis in Metabolic Bariatric Surgery

NCT06510452 | Not Yet Recruiting

• 1 other identifier: AB-BAR-2024
• Study Type: interventional
• Target: 3,352
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Antibiotic Reaction; Wound Infection Superficial; Wound Infection Deep; Bariatric Surgery Candidate; Complication,Postoperative

Keywords

anti-biotics; non-inferiority; surgical side infection

Outcome Measures

Primary Outcomes (1)

• Comparison of incidence of postoperative wound infections in both treatment arms

  Aims to evaluate the non-inferiority of foregoing antibiotic prophylaxis in MBS. The study will compare postoperative outcomes between two groups: Group A, which will not receive antibiotic prophylaxis, and Group B, which will receive standard care including a one-time administration of antibiotics, to test the hypothesis that omitting antibiotic prophylaxis does not significantly increase the incidence of postoperative complications, in particular wound infections.

  until 6 weeks post operative

Study Arms (2)

NACL0.9%

EXPERIMENTAL

Group A will receive 100 ml NACL0.9% without any antibiotics in it.

Drug: NACL 0.9% 100 ml

Cefazolin +Metronidazole

ACTIVE COMPARATOR

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.

Drug: 2000 mg of Cefazolin; Drug: 500 mg of Metronidazole IV

Interventions

2000 mg of Cefazolin DRUG

receive 2000 mg of Cefazolin and 500 mg of Metronidazole IV dissolved in 100 ml NACL0.9%.

Also known as: Kefzol

Cefazolin +Metronidazole

500 mg of Metronidazole IV DRUG

receive 2000 mg of Cefazolin and 500 mg of Metronidazole IV dissolved in 100 ml NACL0.9%.

Also known as: Flagyl

Cefazolin +Metronidazole

NACL 0.9% 100 ml DRUG

receive 100 ml NACL0.9% without any antibiotics in it.

Also known as: Saline

NACL0.9%

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ° Patients must be older than 18 and meet the eligibility criteria for MBS as outlined by the International Federation for the Surgery of Obesity and Metabolic Disorders (IFSO) and the Dutch Federation of Medical Specialists for the surgical treatment of obesity.

You may not qualify if:

• Patients undergoing immunotherapy or corticosteroid treatment for Crohn's disease or rheumatoid arthritis.
• 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.

Sponsors & Collaborators

• General Committee of Teaching Hospitals and Institutes, Egypt: lead

Study Sites (2)

Madina Women's Hospital

Alexandria, 21531, Egypt

Location

WeightWorks clinics

Amersfoort, Utrecht, Netherlands

Location

Related Publications (16)

• CDC antimicrobial resistance. Available from: https://www.cdc.gov/drugresistance/about.html

  BACKGROUND

• 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.

  PMID: 33416442 RESULT

• 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.

  PMID: 31236724 RESULT

• 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.

  PMID: 12841893 RESULT

• 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.

  PMID: 18839083 RESULT

• 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.

  PMID: 10998650 RESULT

• 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.

  PMID: 21126927 RESULT

• Mangram AJ, Horan TC, Pearson ML, Silver LC. Guideline for Prevention of Surgical Site Infection, 1999. 1999;27.

  RESULT

• 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.

  PMID: 23461695 RESULT

• 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.

  PMID: 25376070 RESULT

• 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.

  PMID: 27412673 RESULT

• 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.

  PMID: 36336720 RESULT

• 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.

  PMID: 20934625 RESULT

• 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.

  PMID: 31993070 RESULT

• WHO antimicrobial resistance. Available from: https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance

  RESULT

• 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.

  PMID: 37148398 RESULT

MeSH Terms

Conditions

Postoperative Complications

Interventions

Cefazolin; Metronidazole; Sodium Chloride

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: head of bariatric surgery

Study Record Dates

• First Submitted: July 15, 2024
• First Posted: July 19, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After the study been peer-reviewed for 20 years available.
• Access Criteria: contact the corresponding author

Locations

EG (1); NL (1)