Clinical Trials Logo

Clinical Trial Summary

Antibiotic resistance is a very serious and dangerous situation in modern world. Judicious use of antibiotics is therefore of extreme importance not just in preventing antibiotic resistance but also it decreases cost of the treatment and prevent side-effects of the antibiotics. No randomized trial is available in literature for antibiotic prophylaxis in patient undergoing donor hepatectomy. Currently, antibiotic regimen is based on individual institutional protocol. There have been studies, comparing short course vs long dose of antibiotics in hepatectomy patients, concluding equivalent efficacy in preventing infective complications. The investigators aim at proving that 3 doses of antibiotics are equally effective in preventing infective complications, when compared to 9 doses of antibiotics, in patients undergoing donor hepatectomy. So, a randomized trial is required to study the antibiotic duration in patient undergoing donor hepatectomy.


Clinical Trial Description

Antibiotic resistance is a very serious and dangerous situation in modern world. Judicious use of antibiotics is therefore of extreme importance not just in preventing antibiotic resistance but also it decreases cost of the treatment and prevent side-effects of the antibiotics. No randomized trial is available in literature for antibiotic prophylaxis in patient undergoing donor hepatectomy. Currently, antibiotic regimen is based on individual institutional protocol. So, a randomized trial is required to study the antibiotic duration in patient undergoing donor hepatectomy. The investigators aim to prove that, in preventing infective complications, 3 doses of antibiotics are equally effective as compared to 9 doses of antibiotics in patients of donor hepatectomy. Methodology: The present study will be an equivalence randomized control trial where data will be collected from patients who are undergoing donor hepatectomy. Donor evaluation will be done according to institutional protocol. Donor evaluation will be done step wise as tabulated below. Surgical technique After opening the abdomen through a J-shaped incision, cholecystectomy will be performed and intraoperative cholangiogram will be carried out through the cystic duct stump. The ipsilateral lobe will be mobilized and the hepatic vein will be looped. Hilar dissection will be performed and the ipsilateral portal vein and hepatic artery are defined. The transection plane will be determined by the line of demarcation obtained by temporary clamping of the ipsilateral portal vein and hepatic artery. Parenchymal transection will be performed without inflow occlusion by a Cavitron Ultrasonic Surgical Aspirator (CUSA_; Valleylab, Boulder, CO, USA). The last one-third of the transaction will be performed with a hanging maneuver. After completion of the transaction, the bile duct will be looped along with the sheath and a repeat cholangiogram will be performed by placing radio opaque markers at the proposed bile duct transection site. The bile duct will be divided between the markers. Intravenous heparin will be given (50 IU/kg); after waiting for 3 min, the hepatic artery, portal vein and hepatic vein will be divided between clamps and the graft will be taken out. Assumptions: - Prevalence of infective complications with 3 doses of antibiotic: 9% - Prevalence of infective complications with 9 doses of antibiotic: 7% The alpha error, the power of the study and the equivalence margin will be taken as 5%, 80% and 15% respectively. For this investigators will need to enroll a total of 108 patients, equally divided into 2 groups. Group A shall include 54 consecutive patients who are undergoing donor hepatectomy. These patients will be followed up closely in the post-operative period and would be serially sampled at pre-defined intervals. Patients will be assessed for infective complications. Antibiotics will be continued beyond 3 doses, if any sign of infection is present (Fever/ TLC more than 11,000/ Wound infection/others). Group B shall include 54 patients, who will receive antibiotics for 3 days. These patients will also be followed up closely in the post-operative period and would be serially sampled at pre-defined intervals. Patients will be assessed for infective complications. Antibiotics will be continued beyond 3 days, if any sign of infection is present (Fever/ TLC more than 11,000/ Wound infection/others). Infective complication rates / total duration of antibiotics/ cost of antibiotics and morbidity will be compared between the 2 cohorts. EXPECTED OUTCOME: To establish that 3 doses of antibiotics are equally effective in preventing infective complications, as compared to 9 doses of antibiotics, in patients undergoing donor hepatectomy. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03765645
Study type Interventional
Source Institute of Liver and Biliary Sciences, India
Contact
Status Completed
Phase N/A
Start date October 4, 2018
Completion date August 31, 2020

See also
  Status Clinical Trial Phase
Suspended NCT03990974 - Postoperative Antimicrobial Prophylaxis Versus Placebo for Infection Prevention in HCC After Liver Resection Phase 3
Recruiting NCT05021315 - Vaginal Cleaning Using Povidone Iodine Before CS to Reduce Postoperative Wound Infection Phase 3
Active, not recruiting NCT06177444 - Post-operative Antibiotics; Effects on Risk of Infection After Cochlear Implant Surgery
Completed NCT02713074 - Povidone-iodine Versus Saline in Vaginal Cleansing Before Office Hysteroscopy Phase 3
Completed NCT02591251 - Povidone-iodine Versus Normal Saline Solution in Vaginal Cleansing in Laparoscopy Phase 2
Withdrawn NCT02009098 - RCT of Postoperative Infections Following Caesarean Section Infections Following Caesarean Section Phase 4
Completed NCT01458223 - The Effect of Prolonged Postoperative Antibiotics Administration on Rate of Infection in Patients Undergoing Posterior Spine Surgery Requiring a Hemovac Drain Phase 4
Active, not recruiting NCT04994275 - Impact of Iron Deficiency on the Incidence of Postoperative Infections
Completed NCT01250574 - Neutrophil CD64 and Procalcitonin as Novel Biomarkers for Postoperative Infections
Terminated NCT03231228 - Safety of 1 g and 2 g of Cefazolin in Pediatric Subjects Phase 4
Completed NCT05236751 - Hyperglycemia in Neurosurgery
Completed NCT03926208 - Dilute Betadine Soak and Scrub for Foot and Ankle Surgery N/A
Completed NCT03289351 - Two Different Antibiotics Versus One Antibiotic for Pediatric Perforated Appendicitis Phase 4
Completed NCT01631448 - Fibrin Based Adhesive for the Prevention of Surgical Complications in the Kidney Transplantation Phase 3
Not yet recruiting NCT03249701 - Electrical Acupoint Stimulation for Postoperative Recovery N/A
Completed NCT02828475 - CALYPSO Pilot Study: Machine Learning Based Predictions of Surgical Complications
Completed NCT06265493 - Postoperative Infectious Complications Calculator for Elderly Patients
Completed NCT02436083 - Antibiotics in Free Flaps Reconstructions Phase 4
Recruiting NCT05052619 - Preventive Therapy of Postoperative Intra-abdominal Infection Based on Serum Lactate Changes N/A
Recruiting NCT03903354 - Intraoperative Hyperglycemia and Infections After Orthopedic Surgery