Is an Antibiotic Prescription Required After Laparoscopic Cholecystectomy

October 2, 2020 updated by: Alpaslan Şahin, Konya Meram State Hospital

Is an Antibiotic Prescription Required After Laparoscopic Cholecystectomy for Acute Calculous Cholecystitis?

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

2

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Turkey
      • Konya, Turkey, 42090
        • Konya Training and Research Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Kemal ARSLAN, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 1gr oral ampicillin/sulbactam group
Group prescribed 1 g oral ampicillin/sulbactam 2 times a day.
No Intervention: Antibiotic not prescribed group
Antibiotics not prescribed when discharged after laparoscopic cholecystectomy due to ACC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
surgical site infections
Time Frame: one month
The development of SSI in the operational area or other parts of the body is considered the primary outcome. All patients will be followed up for a postoperative month. It is classified as incisional SSI, CDC guidelines, and superficial, deep, and organ infections.
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konya Meram State Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 15, 2020

Primary Completion (Anticipated)

November 30, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

February 24, 2020

First Submitted That Met QC Criteria

February 27, 2020

First Posted (Actual)

February 28, 2020

Study Record Updates

Last Update Posted (Actual)

October 5, 2020

Last Update Submitted That Met QC Criteria

October 2, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSU Konya HPRC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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