Cholecystitis, AcuteNCT04661371
Necessity of Preoperative Empirical Antibiotic Use in Acute Cholecystitis
A study testing Laparoscopic cholecystectomy in people with Cholecystitis, Acute, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial summary
In this study, the investigators compared the surgical outcomes according to the type of antibiotics before surgery in patients who did not have evidence of systemic infection during acute cholecystitis. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Cholecystitis, Acute
- What is being tested?
- Laparoscopic cholecystectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Mar 2021to 30 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- among patients with mild acute cholecystitis (grade I by Tokyo guidelines) or moderate acute cholecystitis without evidence of gallbladder perforation(grade II)
- cholecystitis with a thickness of 4 mm or more on gallbladder in preoperative imaging
- Gallbladder with surrounding organs due to gallbladder inflammation
- Patients over 19 years of age, under 70 years of age
Who cannot join
- patients with elective gallbladder surgery (chronic cholecystitis)
- gallbladder disease not inflammatory disease (GB cancer, GB polyp)
- pregnant women, patients under 18 years of age, over 70 years of age
- patients with simultaneous surgery due to other organ diseases
- immunosuppressed patients; liver transplant patients, kidney transplant patients, acquired immunodeficiency syndrome patients
- patients with hemorrhagic tendency, or with hematologic diseases
- Patients who underwent percutaneous cholecystectomy (PTGBD)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of HBP Surgery, Seoul St. Mary's hospital
Seoul, Seocho-gu, Banopo-dong, 137-701
About this study
Official title: Necessity of Preoperative Empirical Antibiotic Use in Mild to Moderate Acute Inflammatory Gallbladder Disease; a Randomized Controlled Trial.
In this study, the investigators compared the surgical outcomes according to the type of antibiotics before surgery in patients who did not have evidence of systemic infection during acute cholecystitis.
The primary purpose of the study was to determine the type of preoperative antibiotics in patients who were scheduled for cholecystectomy, because of the mild (grade I) or moderate (grade 2) acute inflammatory gallbladder disease without gallbladder perforation. The investigators compared the incidence of postoperative complications according to the types of preoperative antibiotics(the first-generation vs second-generation cephalosporin).
The secondary purpose of the study was to confirm the clinical efficacy of first-generation cephalosporins following the use of empirical antibiotics. And the investigators compare with postoperative pain, postoperative hospital stay, re-hospitalization, and need for additional treatment. In addition, the investigators compare the postoperative complications, such as atelectasis and postoperative ileus.
Read the detailed description
- Background
- Code name of clinical trial drug or medical device or generic name of main ingredient, raw material drug (raw material in case of medical device) and its quantity, formulation (form / structure / number in case of medical device), etc
- Test drug : normal saline
- control drug : Cefazolin inj., 1 g, Cefazolin sodium, white crystal, vial injection with crystalline powder or lump
- Target disease Acute cholecystitis without evidence of gallbladder perforation among mild (Grade I) and severe (Grade II) classification of acute cholecystitis according to Tokyo guidelines
- Subject selection criteria, exclusion criteria, number of target subjects and their rationale
- Inclusion criteria
- among patients with mild acute cholecystitis (grade I by Tokyo guidelines) or moderate acute cholecystitis without evidence of gallbladder perforation(grade II)
- cholecystitis with a thickness of 4 mm or more on gallbladder in preoperative imaging
- Gallbladder with surrounding organs due to gallbladder inflammation
- Patients over 19 years of age
- Exclusion criteria
- patients with elective gallbladder surgery (chronic cholecystitis)
- gallbladder disease not inflammatory disease (GB cancer, GB polyp)
- pregnant women, patients under 18 years of age, over 70 years of age
- patients with simultaneous surgery due to other organ diseases
- immunosuppressed patients; liver transplant patients, kidney transplant patients, acquired immunodeficiency syndrome patients
- patients with hemorrhagic tendency, or with hematologic diseases
- Patients who underwent percutaneous cholecystectomy (PTGBD)
- Drain tube is required during surgery (eg. if delayed biliary leakage was concerned, hepatic duct injury was suspected or cystic duct ligation was incomplete during operation.)
- Calculation and basis of the number of target subjects In the previous studies, infectious complications after laparoscopic surgery for acute inflammatory gallbladder disease are reported as 2.5%, so it was designed as a non-inferiority experiment between the two groups.After assuming power 80% and 2-sided confidence level 95%, the dropout rate was 10%. Considering this, 90 people were assigned to each group.
- Random allocation schedule and operation Randomization was performed using block randomization without stratification, and a block size of 2, 4 or 6 was applied to complete the randomization table to maintain unpredictability, which was the basic principle of randomization. .
- Assignment bags with random assignment numbers and assigned groups were made of opaque material so that they could be blinded and remain sealed until random assignment was performed for each subject.
- The person in charge of the clinical trial or the person in charge of the clinical trial finally checked the exclusion criteria and, if it was a suitable subject, a random number was assigned and stored in the allocation bag. Thereafter, the management pharmacist receives the assignment bag with the assignment number, releases the seal of the assignment bag, and prescribes antibiotics according to the administration group assigned to the subject according to each random assignment number. Afterwards, the managed pharmacist brought the antibiotics according to the newly developed drug code for the clinical trial in accordance with the [Medical Clinical Trial Management Standards (related to Article 30, Paragraph 1)], and then administered to the patient. The management pharmacist should record the release information (release date and releaser) immediately after the release of the assignment bag which the random assignment enveloped, when it had already been released once, it could not reassign the randomization code to other subjects even if the subject withdraws consent.
- Clinical trial method (administration / dosage, administration / use method, administration / use period, combination therapy, etc.)
- Research Design Prospective randomized controlled trial in two groups
- Describe what treatment is performed for the experimental group / control group A. Clinical trial flow <!-- -->
- Before the patient's surgery, hematology, blood chemistry, blood coagulation, urine, Chest X-ray, EKG, and Abdomen CT were performed in accordance with current clinical practice guidelines.
- Select the patient group that met the diagnostic criteria according to the test results above.
- Select a random patient group to determine the type of empirical antibiotic to use before surgery
- For each selected group, intravenous antibiotics (Cefazolin inj., 1 g, Cefazolin sodium versus. normal saline) were used as before surgery.
- The clinical trial manager or the clinical trial manager finally checked the criteria for selection exclusion and, if it was a suitable subject, a random number was assigned and stored in the allocation bag. Thereafter, the management pharmacist received the assignment bag with the assignment number, released the seal of the assignment bag, and prescribed antibiotics according to the administration group assigned to the subject according to each random assignment number. Afterwards, the managed pharmacist brought the antibiotics according to the newly developed drug code for the clinical trial in accordance with the [Medical Clinical Trial Management Standards (related to Article 30, Paragraph 1)], and then administered to the patient.
- After surgery, both groups were discharged through the same recovery process after surgery.
- On the 1st day after surgery, hematology, blood chemistry, urine, blood clotting, and chest x-rays were performed. (Inspection and treatment were performed according to the current clinical pathway of gallbladder surgery)
- If there are no specifics, a fluid diet was performed starting from lunch on the first day after surgery.
- If there were no specifics, patient would be discharged on the second day after surgery.
- Stability and effectiveness were monitored during hospitalization and after discharge.
- Method of operation
- Surgery was started under general anesthesia
- A trocar of 10 mm was placed on the navel, 5 mm under the blade, and 5 mm trocar was placed on the right upper abdomen.
- Pneumoperitoneum was performed using CO2 gas in the abdominal cavity. - Double pressure through CO2 gas was maintained at 12mmHg / and 2L / min.
- Dissection started from Calot's triangle and the operation was performed by retrograde cholecystectomy.
- The cystic duct was ligated with a 10mm clip and the cystic artery was ligated with a 10mm clip as well.
- If the cystic duct was unstablely ligated, ligation was performed through an endoloop.
- After ligation, the gallbladder was dissected from the liver.
- Washed the surgical site.
- The excised gallbladder was placed in a laparoscopic pocket and extracted through the umbilicus.
- The trocar was removed, the skin was sutured, and the operation was completed. C. Discharge Principle <!-- -->
- When hematologically stable and vital signs were stable
- When the patient's condition was stable by proceeding to the normal diet
- characteristics of observational and clinical test <Observation test>
- Medical history investigation Before entering the clinical trial, checked the following items through interviews, chart and questions about the subject's background (demographic information), medical history, etc., and recorded them in the record. (1) Background investigation: Subject's initials, date of birth, sex, feasibility of pregnancy, pregnancy, lactation (2) medical history (3) History history: History of other diseases 2) Physical examination, vital signs examination Investigators checked whether the body organs were normal or abnormal through medical examination and examination and any significant findings found during the examination should be recorded in the physical examination column of the record sheet, and confirmed to be suitable for participation in the study. After surgery, the pain level was measured by questioning the patient himself using the VAS score, and the amount of analgesics (injection drugs; tramadol and oral drugs; ircodon) administered after surgery to the patient was recorded through medication records.
- Clinical examination It was performed during the hospitalization after decision to perform cholecystectomy. Blood sampling for the subjects was performed aseptically. Investigators recorded the test results, determined whether they were normal or abnormal, and record the opinions of researchers regarding abnormal values. Clinical tests included :
- Hematology tests: Hematocrit, Hemoglobin, MCV, MCH, MCHC, Platelet, WBC \& Differential count, ESR
- Blood coagulation test: PT INR, aPTT, BT
- Blood chemistry test: SGOT (AST), SGPT (ALT), alkaline phosphatase, γ-GTP, bilirubin (total / direct), fasting plasma glucose, BUN, creatinine, sodium, potassium, chloride, calcium, phosphorus, magnesium , total protein, albumin, uric acid, CPK, LDH, free fatty acid, CRP, HbA1c, CRP
- Urine test: Color, specific gravity, pH, Leucocytes, Nitrite, Protein, Glucose, Ketone, Urobilinogen, Bilirubin, Microscopy (RBC, WBC) 4) Imaging medical examination <!-- -->
- Before surgery, chest X-ray and electrocardiography were performed to evaluate whether surgery was possible.
- Imaging studies such as CT, Sonogram, and MRCP were conducted. 5) Postoperative hospital stay The day after surgery, hematology, blood chemistry, urine, blood clotting, Chest x-ray.
- Check for infection.
- Surgical site infection <!-- -->
- Confirmation at every patient visit. Troca insertion site was defined as superficial surgical site infection if there was redness, heat sensation and abscess.
- If there was fluid retention and abscess around the surgical site in the abdominal cavity, it was defined as deep surgical site infection.
- Distant infection
- Respiratory, urinary system infections and bacteremia or lymphangitis 7) Check for leakage of bile.
- Groups who had drainage catheter would be checked through the drainage pattern. In the group without drainage catheter, after surgery, if there is epigastric pain, indigestion, fever, and jaundice, a selective medical imaging test (CT, sonogram, MRCP) was performed.
- Surgery time, bleeding amount were described. 9) Postoperative complications (things other than those described above) were described.
- Predicted side effects and precautions
- Side effects that might occur in the experimental group (the first-generation cephalosporin use group)
- Wound infections and deep infections : Since antibiotics were used, the possibility was very low.
- Side effects of antibiotics (allergic reaction)
- Side effects that could be occurred in the control group (2nd generation cephalosporin use group)
- Extension of the period of stay
- Increased hospitalization costs
- Increase of multi-drug resistant bacteria
- Side effects of antibiotics (allergic reaction) (In the event of side effects, medical judgment was used to actively select a therapeutic method.)
- Stop or drop the test Dosing and testing should be discontinued if any of the following occurs, and the reasons for discontinuation and findings should be recorded.
- After surgery, when a side effect that was life-threatening, the investigator determined that it was necessary to stop
- When the patient refused or withdrew consent after starting the test
- If the patient was inadequate after starting the test
- After the start of the test, if patient had received treatment that might affect the course of treatment, such as other combination drugs and herbal treatments, without the permission of the test manager
- After the start of the test, it was judged that it was impossible to conduct inspection or investigation due to the circumstances
- After surgery, when surgery was required due to a disease of another organ not related to gallbladder surgery.
- Statistical analysis
- Analysis of validity variables A. Analysis of primary efficacy variables.
- During the postoperative hospital stay, the incidence of wound infection and deep infection rates in the group using the first-generation cephalosporin and normal saline as an empirical antibiotic before surgery was determined by the student's t-test or according to the satisfaction of the normal distribution assumption. Test using wilcoxn's rank sum test, and present the descriptive statistics (average, standard deviation, median, minimum, and maximum). Also, the difference in the incidence of infection between the two groups (test group-control group) was presented as the mean and 95% confidence interval, and if it was less than the non-inferiority limit of 13%, the group using the first-generation cephalosporin antibiotics was the second-generation cephalosporin. It was not inferior to the group using antibiotics. That was, it would decide that it was not inferior.
- Complications after surgery.
- Complications will be defined and analyzed through researchers' experience and review of existing literature.
- Fever after surgery: Fever of 37.5 ° C or more that lasts at least 48 hours after surgery. ② Surgical site infection: In case of seroma, hematoma, or abscess in the surgical incision. ③ Surgery wound wound: When the wound was opened and opened. ④ Coming, vomiting after surgery: If patient needed to use antiemetic after 24 hours of surgery, or if patient had vomited even once. ⑤ Sustained shoulder pain after surgery: If patient complained of a stiff shoulder until the outpatient follow-up examination (one week after discharge). ⑥ Bleeding after surgery: When the patient's vital signs change or there was a decrease in Hb 2.0 or higher on the hemoglobin test the day after surgery.
- Abscess in the abdominal cavity after surgery: When an abscess in the abdominal cavity was confirmed by image examination (ultrasound, CT, etc.) accompanied by fever and pain in the physical examination.
- Persistent bowel obstruction: If the meal could not be started even after 2 days of surgery.
- Analysis of secondary efficacy variables In the case of categorical variables for the length of stay, surgical time, and complication data obtained as secondary endpoints, n (%) was presented, and the ratio difference between the two groups was tested using Chi-square or Fisher's exact test. In addition, for continuous variables, the mean, standard deviation, median, minimum, and maximum values were presented, and the normality test was performed to test with Student's t-test for normal distribution, and for the non-normal distribution, Wilcoxon rank-sum test The difference between the two groups would be tested. All statistical analysis would use SPSS version 21.0, and it would be judged that it was statistically significant below the significance level of 0.05.
- Analysis target group <!-- -->
- intention to treat analysis group Randomization would be performed only if the selection criteria described above were met, and all randomized subjects would be included in statistical analysis.
- per protocol analysis group The Per protocol analysis group was defined as a patient who had undergone randomization and had undergone chest imaging the next day after surgery, and whose pain had been assessed.
- How to deal with missing values This study was a prospective study, and it was expected that there would be no missing values of the main or secondary endpoints during the experiment. However, if a missing value occurred, the missing value was substituted with the average value.
- How to deal with compliance Since the intervention applied to this study was an intervention performed during surgery while the patient had general anesthesia, there would be no difference in treatment compliance. In addition, postoperative thoracic imaging and pain assessment were also included in the clinical pathway for laparoscopic cholecystectomy, so there was no difference in treatment compliance.
- Safety evaluation of side effects and reporting method In the event of adverse reactions and adverse reactions after surgery, trained the subject to report to the researcher, checked and recorded the occurrence of adverse reactions at each visit, symptoms, appearance time, duration, severity of adverse reactions, and causal relationship with the test drug Record in the report. In the event of a serious adverse event or unexpected problem, the responsible researcher should report it to the clinical trial.
- Compensation Protocol of victim Laparoscopic cholecystectomy was a safe operation with a very low risk of surgery. Also, there are basically no additional risks accompanying the study. Antibiotics were drugs that had been used before, so there are no additional complications beyond the known complications. If patient got injury or illness by participating in this study, medical treatment would be provided. In order to receive medical treatment related to the clinical symptoms or signs, investigators would make a quick diagnosis and receive treatment when needed through consultation.
- Conditions
- Cholecystitis, Acute
- Being tested
- Laparoscopic cholecystectomy
- Keywords
- empirical antibiotics, postoperative complication
- Medical subject headings
- Cholecystitis, Acute, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic cholecystectomyProcedure or surgery
Also called hematology, blood chemistry, urine, blood clotting, and chest x-rays were performed
Method of operation
- Surgery was started under general anesthesia
- A trocar of 10 mm was placed on the navel, 5 mm under the blade, and 5 mm trocar was placed on the right upper abdomen.
- Pneumoperitoneum was performed using CO2 gas in the abdominal cavity.
- Dissection started from Calot's triangle and the operation was performed by retrograde cholecystectomy.
- The excised gallbladder was placed in a laparoscopic pocket and extracted through the umbilicus.
- The trocar was removed and the skin was sutured
On the 1st day after surgery, hematology, blood chemistry, urine, blood clotting, and chest x-rays were performed. (Inspection and treatment were performed according to the current clinical pathway of gallbladder surgery)
| Study group | Role | What they receive |
|---|---|---|
| The experimental group in acute cholecystitis | Experimental | inclusion criteria
1. among patients with mild acute cholecystitis (grade I by Tokyo guidelines) or moderate acute cholecystitis without evidence of gallbladder perforation(grade II)
2. cholecystitis with a thickness of 4 mm or more on gallbladder in preoperative imaging
3. Gallbladder with surrounding organs due to gallbladder inflammation
4. Patients over 19 years of age
normal saline (Isotonic Sodium Chloride Injection Daihan(50mL/bag)) was used before surgery. Receives: Procedure: Laparoscopic cholecystectomy |
| The controled group in acute cholecystitis | Experimental | 1. among patients with mild acute cholecystitis (grade I by Tokyo guidelines) or moderate acute cholecystitis without evidence of gallbladder perforation(grade II)
2. cholecystitis with a thickness of 4 mm or more on gallbladder in preoperative imaging
3. Gallbladder with surrounding organs due to gallbladder inflammation
4. Patients over 19 years of age
First-generation cephalosporin (Cefazolin inj., 1g, Cefazolin sodium, Chong-geun-dang pharm.co.) was used before surgery. Receives: Procedure: Laparoscopic cholecystectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Infectious Postoperative Complications
Incidence of infectious postoperative complications in patients who underwent a laparoscopic cholecystectomy due to grade I Tokyo guidelines for acute cholecystitis or grade II Tokyo guidelines for acute cholecystitis except the evidence of gallbladder perforation, with the first-generation cephalosporin and normal saline.
Measured: 30 days
Secondary outcomes (1)
Duration of hospitalization
The duration between the operation day and the day of discharge
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
2 Mar 202130 Dec 2021
- First posted10 Dec 2020
- Study start2 Mar 2021 (estimated)
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholecystitis, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taeho Hong, Seoul St. Mary's Hospital
- Investigators
- Sung eun Park, MD, Study director, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661371
- Sponsor's protocol ID
- Seoul-S9
- Status last verified
- Dec 2020
- First submitted
- 3 Dec 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Necessity of Preoperative Empirical Antibiotic Use in Mild to Moderate Acute Inflammatory Gallbladder Disease; a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04661371
- Acronym / sponsor ID
- Seoul-S9
- Conditions
- Cholecystitis, Acute
- Keywords
- empirical antibiotics, postoperative complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- 2 Mar 2021 (estimated)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the investigators compared the surgical outcomes according to the type of antibiotics before surgery in patients who did not have evidence of systemic infection during acute cholecystitis.
The primary purpose of the study was to determine the type of preoperative antibiotics in patients who were scheduled for cholecystectomy, because of the mild (grade I) or moderate (grade 2) acute inflammatory gallbladder disease without gallbladder perforation. The investigators compared the incidence of postoperative complications according to the types of preoperative antibiotics(the first-generation vs second-generation cephalosporin).
The secondary purpose of the study was to confirm the clinical efficacy of first-generation cephalosporins following the use of empirical antibiotics. And the investigators compare with postoperative pain, postoperative hospital stay, re-hospitalization, and need for additional treatment. In addition, the investigators compare the postoperative complications, such as atelectasis and postoperative ileus.
Detailed description
- Background
- Code name of clinical trial drug or medical device or generic name of main ingredient, raw material drug (raw material in case of medical device) and its quantity, formulation (form / structure / number in case of medical device), etc
- Test drug : normal saline
- control drug : Cefazolin inj., 1 g, Cefazolin sodium, white crystal, vial injection with crystalline powder or lump
- Target disease Acute cholecystitis without evidence of gallbladder perforation among mild (Grade I) and severe (Grade II) classification of acute cholecystitis according to Tokyo guidelines
- Subject selection criteria, exclusion criteria, number of target subjects and their rationale
- Inclusion criteria
- among patients with mild acute cholecystitis (grade I by Tokyo guidelines) or moderate acute cholecystitis without evidence of gallbladder perforation(grade II)
- cholecystitis with a thickness of 4 mm or more on gallbladder in preoperative imaging
- Gallbladder with surrounding organs due to gallbladder inflammation
- Patients over 19 years of age
- Exclusion criteria
- patients with elective gallbladder surgery (chronic cholecystitis)
- gallbladder disease not inflammatory disease (GB cancer, GB polyp)
- pregnant women, patients under 18 years of age, over 70 years of age
- patients with simultaneous surgery due to other organ diseases
- immunosuppressed patients; liver transplant patients, kidney transplant patients, acquired immunodeficiency syndrome patients
- patients with hemorrhagic tendency, or with hematologic diseases
- Patients who underwent percutaneous cholecystectomy (PTGBD)
- Drain tube is required during surgery (eg. if delayed biliary leakage was concerned, hepatic duct injury was suspected or cystic duct ligation was incomplete during operation.)
- Calculation and basis of the number of target subjects In the previous studies, infectious complications after laparoscopic surgery for acute inflammatory gallbladder disease are reported as 2.5%, so it was designed as a non-inferiority experiment between the two groups.After assuming power 80% and 2-sided confidence level 95%, the dropout rate was 10%. Considering this, 90 people were assigned to each group.
- Random allocation schedule and operation Randomization was performed using block randomization without stratification, and a block size of 2, 4 or 6 was applied to complete the randomization table to maintain unpredictability, which was the basic principle of randomization. .
- Assignment bags with random assignment numbers and assigned groups were made of opaque material so that they could be blinded and remain sealed until random assignment was performed for each subject.
- The person in charge of the clinical trial or the person in charge of the clinical trial finally checked the exclusion criteria and, if it was a suitable subject, a random number was assigned and stored in the allocation bag. Thereafter, the management pharmacist receives the assignment bag with the assignment number, releases the seal of the assignment bag, and prescribes antibiotics according to the administration group assigned to the subject according to each random assignment number. Afterwards, the managed pharmacist brought the antibiotics according to the newly developed drug code for the clinical trial in accordance with the [Medical Clinical Trial Management Standards (related to Article 30, Paragraph 1)], and then administered to the patient. The management pharmacist should record the release information (release date and releaser) immediately after the release of the assignment bag which the random assignment enveloped, when it had already been released once, it could not reassign the randomization code to other subjects even if the subject withdraws consent.
- Clinical trial method (administration / dosage, administration / use method, administration / use period, combination therapy, etc.)
- Research Design Prospective randomized controlled trial in two groups
- Describe what treatment is performed for the experimental group / control group A. Clinical trial flow <!-- -->
- Before the patient's surgery, hematology, blood chemistry, blood coagulation, urine, Chest X-ray, EKG, and Abdomen CT were performed in accordance with current clinical practice guidelines.
- Select the patient group that met the diagnostic criteria according to the test results above.
- Select a random patient group to determine the type of empirical antibiotic to use before surgery
- For each selected group, intravenous antibiotics (Cefazolin inj., 1 g, Cefazolin sodium versus. normal saline) were used as before surgery.
- The clinical trial manager or the clinical trial manager finally checked the criteria for selection exclusion and, if it was a suitable subject, a random number was assigned and stored in the allocation bag. Thereafter, the management pharmacist received the assignment bag with the assignment number, released the seal of the assignment bag, and prescribed antibiotics according to the administration group assigned to the subject according to each random assignment number. Afterwards, the managed pharmacist brought the antibiotics according to the newly developed drug code for the clinical trial in accordance with the [Medical Clinical Trial Management Standards (related to Article 30, Paragraph 1)], and then administered to the patient.
- After surgery, both groups were discharged through the same recovery process after surgery.
- On the 1st day after surgery, hematology, blood chemistry, urine, blood clotting, and chest x-rays were performed. (Inspection and treatment were performed according to the current clinical pathway of gallbladder surgery)
- If there are no specifics, a fluid diet was performed starting from lunch on the first day after surgery.
- If there were no specifics, patient would be discharged on the second day after surgery.
- Stability and effectiveness were monitored during hospitalization and after discharge.
- Method of operation
- Surgery was started under general anesthesia
- A trocar of 10 mm was placed on the navel, 5 mm under the blade, and 5 mm trocar was placed on the right upper abdomen.
- Pneumoperitoneum was performed using CO2 gas in the abdominal cavity. - Double pressure through CO2 gas was maintained at 12mmHg / and 2L / min.
- Dissection started from Calot's triangle and the operation was performed by retrograde cholecystectomy.
- The cystic duct was ligated with a 10mm clip and the cystic artery was ligated with a 10mm clip as well.
- If the cystic duct was unstablely ligated, ligation was performed through an endoloop.
- After ligation, the gallbladder was dissected from the liver.
- Washed the surgical site.
- The excised gallbladder was placed in a laparoscopic pocket and extracted through the umbilicus.
- The trocar was removed, the skin was sutured, and the operation was completed. C. Discharge Principle <!-- -->
- When hematologically stable and vital signs were stable
- When the patient's condition was stable by proceeding to the normal diet
- characteristics of observational and clinical test <Observation test>
- Medical history investigation Before entering the clinical trial, checked the following items through interviews, chart and questions about the subject's background (demographic information), medical history, etc., and recorded them in the record. (1) Background investigation: Subject's initials, date of birth, sex, feasibility of pregnancy, pregnancy, lactation (2) medical history (3) History history: History of other diseases 2) Physical examination, vital signs examination Investigators checked whether the body organs were normal or abnormal through medical examination and examination and any significant findings found during the examination should be recorded in the physical examination column of the record sheet, and confirmed to be suitable for participation in the study. After surgery, the pain level was measured by questioning the patient himself using the VAS score, and the amount of analgesics (injection drugs; tramadol and oral drugs; ircodon) administered after surgery to the patient was recorded through medication records.
- Clinical examination It was performed during the hospitalization after decision to perform cholecystectomy. Blood sampling for the subjects was performed aseptically. Investigators recorded the test results, determined whether they were normal or abnormal, and record the opinions of researchers regarding abnormal values. Clinical tests included :
- Hematology tests: Hematocrit, Hemoglobin, MCV, MCH, MCHC, Platelet, WBC \& Differential count, ESR
- Blood coagulation test: PT INR, aPTT, BT
- Blood chemistry test: SGOT (AST), SGPT (ALT), alkaline phosphatase, γ-GTP, bilirubin (total / direct), fasting plasma glucose, BUN, creatinine, sodium, potassium, chloride, calcium, phosphorus, magnesium , total protein, albumin, uric acid, CPK, LDH, free fatty acid, CRP, HbA1c, CRP
- Urine test: Color, specific gravity, pH, Leucocytes, Nitrite, Protein, Glucose, Ketone, Urobilinogen, Bilirubin, Microscopy (RBC, WBC) 4) Imaging medical examination <!-- -->
- Before surgery, chest X-ray and electrocardiography were performed to evaluate whether surgery was possible.
- Imaging studies such as CT, Sonogram, and MRCP were conducted. 5) Postoperative hospital stay The day after surgery, hematology, blood chemistry, urine, blood clotting, Chest x-ray.
- Check for infection.
- Surgical site infection <!-- -->
- Confirmation at every patient visit. Troca insertion site was defined as superficial surgical site infection if there was redness, heat sensation and abscess.
- If there was fluid retention and abscess around the surgical site in the abdominal cavity, it was defined as deep surgical site infection.
- Distant infection
- Respiratory, urinary system infections and bacteremia or lymphangitis 7) Check for leakage of bile.
- Groups who had drainage catheter would be checked through the drainage pattern. In the group without drainage catheter, after surgery, if there is epigastric pain, indigestion, fever, and jaundice, a selective medical imaging test (CT, sonogram, MRCP) was performed.
- Surgery time, bleeding amount were described. 9) Postoperative complications (things other than those described above) were described.
- Predicted side effects and precautions
- Side effects that might occur in the experimental group (the first-generation cephalosporin use group)
- Wound infections and deep infections : Since antibiotics were used, the possibility was very low.
- Side effects of antibiotics (allergic reaction)
- Side effects that could be occurred in the control group (2nd generation cephalosporin use group)
- Extension of the period of stay
- Increased hospitalization costs
- Increase of multi-drug resistant bacteria
- Side effects of antibiotics (allergic reaction) (In the event of side effects, medical judgment was used to actively select a therapeutic method.)
- Stop or drop the test Dosing and testing should be discontinued if any of the following occurs, and the reasons for discontinuation and findings should be recorded.
- After surgery, when a side effect that was life-threatening, the investigator determined that it was necessary to stop
- When the patient refused or withdrew consent after starting the test
- If the patient was inadequate after starting the test
- After the start of the test, if patient had received treatment that might affect the course of treatment, such as other combination drugs and herbal treatments, without the permission of the test manager
- After the start of the test, it was judged that it was impossible to conduct inspection or investigation due to the circumstances
- After surgery, when surgery was required due to a disease of another organ not related to gallbladder surgery.
- Statistical analysis
- Analysis of validity variables A. Analysis of primary efficacy variables.
- During the postoperative hospital stay, the incidence of wound infection and deep infection rates in the group using the first-generation cephalosporin and normal saline as an empirical antibiotic before surgery was determined by the student's t-test or according to the satisfaction of the normal distribution assumption. Test using wilcoxn's rank sum test, and present the descriptive statistics (average, standard deviation, median, minimum, and maximum). Also, the difference in the incidence of infection between the two groups (test group-control group) was presented as the mean and 95% confidence interval, and if it was less than the non-inferiority limit of 13%, the group using the first-generation cephalosporin antibiotics was the second-generation cephalosporin. It was not inferior to the group using antibiotics. That was, it would decide that it was not inferior.
- Complications after surgery.
- Complications will be defined and analyzed through researchers' experience and review of existing literature.
- Fever after surgery: Fever of 37.5 ° C or more that lasts at least 48 hours after surgery. ② Surgical site infection: In case of seroma, hematoma, or abscess in the surgical incision. ③ Surgery wound wound: When the wound was opened and opened. ④ Coming, vomiting after surgery: If patient needed to use antiemetic after 24 hours of surgery, or if patient had vomited even once. ⑤ Sustained shoulder pain after surgery: If patient complained of a stiff shoulder until the outpatient follow-up examination (one week after discharge). ⑥ Bleeding after surgery: When the patient's vital signs change or there was a decrease in Hb 2.0 or higher on the hemoglobin test the day after surgery.
- Abscess in the abdominal cavity after surgery: When an abscess in the abdominal cavity was confirmed by image examination (ultrasound, CT, etc.) accompanied by fever and pain in the physical examination.
- Persistent bowel obstruction: If the meal could not be started even after 2 days of surgery.
- Analysis of secondary efficacy variables In the case of categorical variables for the length of stay, surgical time, and complication data obtained as secondary endpoints, n (%) was presented, and the ratio difference between the two groups was tested using Chi-square or Fisher's exact test. In addition, for continuous variables, the mean, standard deviation, median, minimum, and maximum values were presented, and the normality test was performed to test with Student's t-test for normal distribution, and for the non-normal distribution, Wilcoxon rank-sum test The difference between the two groups would be tested. All statistical analysis would use SPSS version 21.0, and it would be judged that it was statistically significant below the significance level of 0.05.
- Analysis target group <!-- -->
- intention to treat analysis group Randomization would be performed only if the selection criteria described above were met, and all randomized subjects would be included in statistical analysis.
- per protocol analysis group The Per protocol analysis group was defined as a patient who had undergone randomization and had undergone chest imaging the next day after surgery, and whose pain had been assessed.
- How to deal with missing values This study was a prospective study, and it was expected that there would be no missing values of the main or secondary endpoints during the experiment. However, if a missing value occurred, the missing value was substituted with the average value.
- How to deal with compliance Since the intervention applied to this study was an intervention performed during surgery while the patient had general anesthesia, there would be no difference in treatment compliance. In addition, postoperative thoracic imaging and pain assessment were also included in the clinical pathway for laparoscopic cholecystectomy, so there was no difference in treatment compliance.
- Safety evaluation of side effects and reporting method In the event of adverse reactions and adverse reactions after surgery, trained the subject to report to the researcher, checked and recorded the occurrence of adverse reactions at each visit, symptoms, appearance time, duration, severity of adverse reactions, and causal relationship with the test drug Record in the report. In the event of a serious adverse event or unexpected problem, the responsible researcher should report it to the clinical trial.
- Compensation Protocol of victim Laparoscopic cholecystectomy was a safe operation with a very low risk of surgery. Also, there are basically no additional risks accompanying the study. Antibiotics were drugs that had been used before, so there are no additional complications beyond the known complications. If patient got injury or illness by participating in this study, medical treatment would be provided. In order to receive medical treatment related to the clinical symptoms or signs, investigators would make a quick diagnosis and receive treatment when needed through consultation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental group in acute cholecystitis | Experimental | Procedure: Laparoscopic cholecystectomyinclusion criteria 1. among patients with mild acute cholecystitis (grade I by Tokyo guidelines) or moderate acute cholecystitis without evidence of gallbladder perforation(grade II) 2. cholecystitis with a thickness of 4 mm or more on gallbladder in preoperative imaging 3. Gallbladder with surrounding organs due to gallbladder inflammation 4. Patients over 19 years of age normal saline (Isotonic Sodium Chloride Injection Daihan(50mL/bag)) was used before surgery. |
| The controled group in acute cholecystitis | Experimental | Procedure: Laparoscopic cholecystectomy1. among patients with mild acute cholecystitis (grade I by Tokyo guidelines) or moderate acute cholecystitis without evidence of gallbladder perforation(grade II) 2. cholecystitis with a thickness of 4 mm or more on gallbladder in preoperative imaging 3. Gallbladder with surrounding organs due to gallbladder inflammation 4. Patients over 19 years of age First-generation cephalosporin (Cefazolin inj., 1g, Cefazolin sodium, Chong-geun-dang pharm.co.) was used before surgery. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- among patients with mild acute cholecystitis (grade I by Tokyo guidelines) or moderate acute cholecystitis without evidence of gallbladder perforation(grade II)
- cholecystitis with a thickness of 4 mm or more on gallbladder in preoperative imaging
- Gallbladder with surrounding organs due to gallbladder inflammation
- Patients over 19 years of age, under 70 years of age
Key exclusion criteria (7 listed)
- patients with elective gallbladder surgery (chronic cholecystitis)
- gallbladder disease not inflammatory disease (GB cancer, GB polyp)
- pregnant women, patients under 18 years of age, over 70 years of age
- patients with simultaneous surgery due to other organ diseases
- immunosuppressed patients; liver transplant patients, kidney transplant patients, acquired immunodeficiency syndrome patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic cholecystectomyAlso: hematology, blood chemistry, urine, blood clotting, and chest x-rays were performedMethod of operation 1. Surgery was started under general anesthesia 2. A trocar of 10 mm was placed on the navel, 5 mm under the blade, and 5 mm trocar was placed on the right upper abdomen. 3. Pneumoperitoneum was performed using CO2 gas in the abdominal cavity. 4. Dissection started from Calot's triangle and the operation was performed by retrograde cholecystectomy. 5. The excised gallbladder was placed in a laparoscopic pocket and extracted through the umbilicus. 6. The trocar was removed and the skin was sutured On the 1st day after surgery, hematology, blood chemistry, urine, blood clotting, and chest x-rays were performed. (Inspection and treatment were performed according to the current clinical pathway of gallbladder surgery) | Procedure or surgery | The controled group in acute cholecystitis, The experimental group in acute cholecystitis |
Primary outcome
Number of Participants with Infectious Postoperative Complications
Time frame: 30 days
Incidence of infectious postoperative complications in patients who underwent a laparoscopic cholecystectomy due to grade I Tokyo guidelines for acute cholecystitis or grade II Tokyo guidelines for acute cholecystitis except the evidence of gallbladder perforation, with the first-generation cephalosporin and normal saline.
1 secondary outcome
Duration of hospitalization
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung eun Park, MD study director
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic cholecystectomy in people with Cholecystitis, Acute, run by Seoul St. Mary's Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tae ho Hong, MD. PhD (+82-10-5206-5266, gshth@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Infectious Postoperative Complications (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2020.