Is an Antibiotic Prescription Required After Laparoscopic Cholecystectomy

NCT ID: NCT04290104

Last Updated: 2020-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-15
• Study Completion Date: 2020-12-31

Brief Summary

The need for antibiotics to reduce surgical site infection after cholecystectomy for acute calculous cholecystitis is still controversial. The researchers aimed to investigate the effect of antibiotics prescribed on surgical site infection when discharged to patients undergoing laparoscopic cholecystectomy for acute calculous cholecystitis.

Detailed Description

Cholecystectomy is the definitive treatment for acute calculous cholecystitis (ACC). In the past, the timing of cholecystectomy has been the subject of debate. Early cholecystectomy performed within 72 hours at the beginning of the disease is preferred to first medical treatment and delayed cholecystectomy 6 to 10 weeks after recovery. In many studies, it suggests early cholecystectomy because it provides a definitive solution, faster recovery times, and more rapid return to work.

Surgical site infections (SSIs) are a significant cause of mortality and morbidity after surgery. In the United States alone, more than 300,000 surgical field infections are seen annually. Again, in the United States alone, the budget spent on surgical site infection reaches $ 10 billion. Antibiotic treatment in ACC patients to prevent surgical site infection is a standard practice in the hospital before and after surgery. However, there is controversy over the use of antibiotics to prevent surgical site infection after discharge. The researchers aimed to investigate the effect of antibiotics prescribed on surgical site infection when discharged to patients undergoing laparoscopic cholecystectomy (LC) for acute calculous cholecystitis.

Patients and Method Patients who were admitted to the General Surgery Clinic with the diagnosis of acute calculous cholecystitis and who underwent early Laparoscopic Cholecystectomy will be included in the study. Patients will be told in detail about the study protocol, and those who accept it will be included in the study. A study consent form, which is written and signed by patients in their handwriting, will be taken. The patients will be staged as Stage 1,2,3 according to the TG13 criteria accepted at the Tokyo 2013 consensus. The anesthesiologist will make ASA classification. Oral intake of the patients will be stopped, and parenteral fluid and anti biotherapy will be applied. The demographic characteristics, comorbidities of the patients, will be recorded in their files, whether they had previous ACC attacks. Patients will be operated within 12-72 hours after hospitalization. Amoxycillin / sulbactam 1 g will be administered parenterally three times a day to patients before and after surgery. Patients included in the post-operative study will be discharged within three days at the latest if the complication has not developed. Just before discharge, the clinical secretary will give a code to each patient with the help of a computer program, and block randomization will be made and divided into two groups. Those who received oral antibiotics (AB group) and those who did not receive antibiotics (HA group).

The primary purpose of antibiotic therapy in ACC is to limit both systemic septic response and local inflammation to prevent SSI in the superficial wound, fascia, and organ cavity. In this study, ampicillin/sulbactam will be used according to the TG18 guidelines (according to recommendation). If the patient is in the AB group, 1 g of ampicillin/sulbactam will be prescribed two times a day and will use for a total of 5-7 days. All demographic features and medical processes of the patients will be recorded electronically with the hospital medical computer program (Deva Data ®).

If SSI is detected by clinical examination and other diagnostic methods (laboratory, ultrasound, and tomography), the antibiotic regimen will be changed in the AB group, and ampicillin/sulbactam will be started in the NA group. Also, superficial and deep SSI will locally be drained, organ SSI will be drained by ultrasonography or tomography-guided.

Sample size calculation: As the reported rate of postoperative SSIs associated with ACC varies between 1% and 15%, it was estimated that 102 patients per group would allow detecting a 10% difference in the rate of complications with 80% power with a confidence interval of 5%. The estimated price of loss to follow-up was 10%; therefore, at least 112 patients were needed to be enrolled for each group.

Conditions

Cholecystitis; Acute, With Cholelithiasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1gr oral ampicillin/sulbactam group

The group to be prescribed 1 g oral ampicillin/sulbactam twice a day while discharged after laparoscopic cholecystectomy due to ACC.

Group Type: EXPERIMENTAL

1gr oral ampicillin/sulbactam group

Intervention Type: DRUG

Group prescribed 1 g oral ampicillin/sulbactam 2 times a day.

Antibiotic not prescribed group

Antibiotics not prescribed when discharged after laparoscopic cholecystectomy due to ACC.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

1gr oral ampicillin/sulbactam group

Group prescribed 1 g oral ampicillin/sulbactam 2 times a day.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Acute calculous cholecystitis patients over the age of 18 will be included.

Exclusion Criteria

• Laparoscopic cholecystectomy patients who have been elective for symptomatic cholelithiasis,
• Patients who are hospitalized with ACC and who undergo late LC, have decompensated systemic disease,
• Patients with ASA 4,
• Patients who underwent surgery for early LC due to ACC diagnosis and left laparoscopic method for reasons such as difficult dissection and underwent open cholecystectomy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Konya Meram State Hospital

OTHER

Sponsor Role: lead

Responsible Party

Alpaslan Şahin

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Konya Training and Research Hospital

Konya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Kemal ARSLAN, MD

Role: CONTACT

arslanka74@hotmail.com

+905059137791

Alpaslan ŞAHIN, MD

Role: CONTACT

drasahin@gmail.com

05052955095

Facility Contacts

Kemal ARSLAN, MD

Role: primary

arslanka74@hotmail.com

+905059137791

Gurcan Şimşek, MD

Role: backup

drgurcansimsek@gmail.com

+903322210000 ext. 7208

References

Magill SS, Edwards JR, Fridkin SK; Emerging Infections Program Healthcare-Associated Infections and Antimicrobial Use Prevalence Survey Team. Survey of health care-associated infections. N Engl J Med. 2014 Jun 26;370(26):2542-3. doi: 10.1056/NEJMc1405194. No abstract available.

Reference Type: BACKGROUND

PMID: 24963580 (View on PubMed)

Duncan CB, Riall TS. Evidence-based current surgical practice: calculous gallbladder disease. J Gastrointest Surg. 2012 Nov;16(11):2011-25. doi: 10.1007/s11605-012-2024-1. Epub 2012 Sep 18.

Reference Type: BACKGROUND

PMID: 22986769 (View on PubMed)

Other Identifiers

HSU Konya HPRC

Identifier Type: -

Identifier Source: org_study_id