Removal of gall bladder by laparoscope without antibiotics

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2022/11/047440

Lead Sponsor: Lady Hardinge Medical College

Brief Summary: Laparoscopic cholecystectomy (LC) is thestandard treatment for symptomatic cholelithiasis. The mainadvantages of LC include less postoperative pain, shorter hospital stays, lowermorbidity and mortality, and a lower rate of postoperative infection. Theincidence of post-operative infectious complications after LC is significantlylower compared with that of open cholecystectomy. The use of prophylacticantibiotics as a means of preventing surgical site infection (SSIs) is acommonly practiced culture in uncomplicated or complicated elective LC. Manysurgeons use and recommend the administration of prophylactic antibiotics. On the contrary, many surgeons believe that antibiotic prophylaxismay not be necessary in low-risk patients undergoing elective LC. Surgical site infections is a significant postoperative complication which canlead to considerable patient morbidity and mortality. Preventingpostoperative infection is an essential component in concluding the results ofsuccessful surgical procedures. One approach to prevent postoperative infectionis administration of prophylactic antibiotics. The benefits of prophylacticantibiotics is to reduce bacterial contamination during clean-contaminatedoperations such as elective cholecystectomy.

Even though there areguidelines which donâ€™t recommend antibiotic prophylaxis in electivelaparoscopic surgeries , it is not being followed in India due to variousreasons like Indian hospitals areconsidered to have presumed doubtful sterilization practices , medicolegalissues, possible increase in cost to bear long hospital stay due to anypostoperative infectious complications .

The aim of this study is toinvestigate the necessity of prophylactic antibiotics to prevent postoperativeinfectious complications in low-risk patients undergoing elective laparoscopiccholecystectomy. This will help reduce antibiotic resistance, irrational use,and unnecessary burden of cost, apart from promoting Antimicrobial StewardshipProgram.

There is no guidelines and minimalliterature available on evaluation of role of prophylactic antibiotics in lowrisk elective laparoscopic cholecystectomy in India . The study results on thistopic will benefit and contribute as an important quality index to hospitals inIndia and break the myth of presumed doubtful sterilization practices in Indianhospitals. This will also lead to rational antibiotic practices and promoteAntimicrobial Stewardship Program.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

All patients for elective laparoscopic cholecystectomy of either gender with ASA Grade 1.

Exclusion Criteria

Antibiotic intake in 7 days prior to surgery 2) Regular corticosteroid therapy, immunodeficiency 3) Pregnancy or lactation.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Odds ratio of patients who develop SSI with antibiotic prophylaxis	Post operative Day 7 and 30
2. Odds ratio of patients who develop SSI without antibiotic prophylaxis	Post operative Day 7 and 30

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Sucheta Kriplani Hospital
🇮🇳
Central, DELHI, India
Sucheta Kriplani Hospital
🇮🇳Central, DELHI, India
Dr Supriya Raj
Principal investigator
9958141815
supriyaraj3112@gmail.com