Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06510452
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Antibiotic Prophylaxis in Metabolic Bariatric Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of Antibiotic Prophylaxis in Metabolic Bariatric Surgery A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ParametersEndpoints Compare the incidence of incisional and organspace SSIs within six weeks post-surgery between Group A and Group B to determine if omitting antibiotics affects infection rates
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 ParametersEndpoints Compare the incidence of incisional and organspace SSIs within six weeks post-surgery between Group A and Group B to determine if omitting antibiotics affects infection rates
Detailed Description:
Nature and Extent of the Burden and Risks
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 organspace 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
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 organspace 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None