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A study comparing the patients who were given and those who were not given prophylacyic antibiotics before a planned laparoscopic gallbladder surgery

Prophylactic antibiotic versus no antibiotic in patients undergoing elective laparoscopic cholecystectomy: a randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/071617
Enrollment
172
Registered
2024-07-31
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Normal saline: 10ml to be injected intravenously within 1 hour of start of surgery as placebo to group without prophylactic antibiotic Control Intervention1: Injection CEFTRIAXONE SULBA

Sponsors

Regional Institute of Medical Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Diagnosed case of Gall stone disease/ GB polyp/ Chronic cholecystitis 2.>=18 years of age

Exclusion criteria

Exclusion criteria: 1.Antibiotic use within 7 days of planned laparoscopic cholecystectomy 2.Mucocele, Empyema, Gangrenous gall bladder 3.Preoperative ERCP or concomitant choledocholithiasis 4.Medical comorbidities (e.g. Diabetes, Malignancy, Immunocompromised) 5.Patients requiring antibiotics for any other reasons 6.Intraoperative gall bladder rupture or biliary spillage

Design outcomes

Secondary

MeasureTime frame
Post operative infectious complicationsTimepoint: 1.Post Operative Day 1 2.Post Operative Day 2 3.Post Operative Day 7 4.Post operative Day 14 5.Post operative Day 21 6.Post operative Day 30—

Primary

MeasureTime frame
1.Surgical site infection 2.Duration of hospital stayTimepoint: 1.Post Operative Day 1 2.Post Operative Day 2 3.Post Operative Day 7 4.Post operative Day 14 5.Post operative Day 21 6.Post operative Day 30—

Countries

India

Contacts

Public ContactDr Suman Kumar Roy

Regional Institute of Medical Sciences, Imphal

cmaibam82@gmail.com9774524948

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 14, 2026