Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04290104 |
| Other study ID # |
HSU Konya HPRC |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
October 15, 2020 |
| Est. completion date |
December 31, 2020 |
Study information
| Verified date |
October 2020 |
| Source |
Konya Training and Research Hospital |
| Contact |
Kemal ARSLAN, MD |
| Phone |
+905059137791 |
| Email |
arslanka74[@]hotmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
