Acute CholecystitisNCT02490293
Is it Fair to Use Antibiotics After Laparoscopic Cholecystectomy for the Patients With Acutely Inflamed Gallbladder?
A study testing Cephalosporin in people with Acute Cholecystitis, run by Taeho Hong at 1 site in South Korea.
Trial summary
During the laparoscopic cholecystectomy for acute cholecystitis, most surgeons routinely use the postoperative antibiotics after surgery. However, there is no consensus regarding the actual need of postoperative antibiotics in these cases and the use of postoperative antibiotics remains controversial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Cholecystitis
- What is being tested?
- Cephalosporin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 198 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2015to Jun 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- grade I Tokyo guideline for acute cholecystitis
- grade II Tokyo guideline for acute cholecystitis without the evidence of gallbladder perforation
Who cannot join
- chronic cholecystitis
- gallbladder polyp or gallbladder cancer
- the patient who underwent reduced port surgery
- the patient who underwent common bile duct exploration during the operation
- the patient who underwent concurrent operation
- the patient who had past history of upper abdominal surgery
Show all 11Show fewer
- the patient who had a immunodeficiency state
- the case which had a suspicion of delayed bile leakage
- the case which had a incomplete cystic duct ligation
- the patient who underwent open conversion surgery during the operation
- the patient who had a high risk of bleeding
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul St. Mary's hospital
Seoul, Seocho-gu, Banopo-dong, 137-701
About this study
Official title: Is it Fair to Use Antibiotics After Laparoscopic Cholecystectomy for the Patients With Acutely Inflamed Gallbladder?; a Multicenter Randomized Controlled Trial
During the laparoscopic cholecystectomy for acute cholecystitis, most surgeons routinely use the postoperative antibiotics after surgery. However, there is no consensus regarding the actual need of postoperative antibiotics in these cases and the use of postoperative antibiotics remains controversial.
Investigators will compare the surgical outcomes after laparoscopic cholecystectomy to the patients who has no evidence of systemic infection, according to the usage of postoperative antibiotics or not. The investigators expect that the routine use of postoperative antibiotics after laparoscopic cholecystectomy for acute cholecystitis gallbladder will have no effects on the postoperative morbidity.
Read the detailed description
Primary outcome of this study is the confirmation of safety in the cases of acute cholecystitis without postoperative antibiotics usage after laparoscopic cholecystectomy. For this purpose, the investigators compare the surgical infectious outcomes including the wound infection or abdominal infections according to the usage of postoperative antibiotics after laparoscopic cholecystectomy.
Secondary outcome of this study is the confirmation of efficacy according to skip the use of postoperative antibiotics after laparoscopic cholecystectomy.
The investigators estimate the efficacy using the comparing the outcomes such as duration of hospitalization according to the use of postoperative antibiotics or not.
- Conditions
- Acute Cholecystitis
- Being tested
- Cephalosporin, Placebo
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CephalosporinDrug
Also called 'Pacetin'
During the hospitalization, intake of pacetin, 2nd generation cephalosporin. 3 g per day divided into 3 times via intravenous route until the day of discharge.
After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days.
PlaceboDrug
Also called normal saline and vitamin C
During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.
After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days.
| Study group | Role | What they receive |
|---|---|---|
| Group A (cephalosporin) | Experimental | During the period of hospitalization, intake of active drug ('pacetin', 2nd generation cephalosporin). 3 g per day divided into 3 times via intravenous route until the day of discharge.
After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days. Receives: Drug: Cephalosporin |
| Group B (placebo) | Placebo comparator | During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.
After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days. Receives: Drug: Placebo |
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 antibiotics or placebo
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.
- First posted3 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute CholecystitisStudies 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
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taeho Hong
- Sponsor type
- University, hospital or other
- Collaborators
- Incheon St.Mary's Hospital, Bucheon St. Mary's Hospital, Uijeongbu St. Mary Hospital, Catholic University of Korea Saint Paul's Hospital
- Responsible party
- Sponsor-investigator, Taeho Hong, Seoul St. Mary's Hospital
- Investigators
- Taeho Hong, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490293
- Sponsor's protocol ID
- Seoul-05
- Status last verified
- Feb 2017
- First submitted
- 15 Jun 2015
- Last updated
- 7 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is it Fair to Use Antibiotics After Laparoscopic Cholecystectomy for the Patients With Acutely Inflamed Gallbladder?; a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02490293
- Acronym / sponsor ID
- Seoul-05
- Conditions
- Acute Cholecystitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Taeho HongUniversity, hospital or other
- Collaborators
- Incheon St.Mary's Hospital, Bucheon St. Mary's Hospital, Uijeongbu St. Mary Hospital, Catholic University of Korea Saint Paul's Hospital
- Study start
- Jun 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 3 Jul 2015 (estimated)
- Results
- Posted 7 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During the laparoscopic cholecystectomy for acute cholecystitis, most surgeons routinely use the postoperative antibiotics after surgery. However, there is no consensus regarding the actual need of postoperative antibiotics in these cases and the use of postoperative antibiotics remains controversial.
Investigators will compare the surgical outcomes after laparoscopic cholecystectomy to the patients who has no evidence of systemic infection, according to the usage of postoperative antibiotics or not. The investigators expect that the routine use of postoperative antibiotics after laparoscopic cholecystectomy for acute cholecystitis gallbladder will have no effects on the postoperative morbidity.
Detailed description
Primary outcome of this study is the confirmation of safety in the cases of acute cholecystitis without postoperative antibiotics usage after laparoscopic cholecystectomy. For this purpose, the investigators compare the surgical infectious outcomes including the wound infection or abdominal infections according to the usage of postoperative antibiotics after laparoscopic cholecystectomy.
Secondary outcome of this study is the confirmation of efficacy according to skip the use of postoperative antibiotics after laparoscopic cholecystectomy.
The investigators estimate the efficacy using the comparing the outcomes such as duration of hospitalization according to the use of postoperative antibiotics or not.
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 |
|---|---|---|
| Group A (cephalosporin) | Experimental | Drug: CephalosporinDuring the period of hospitalization, intake of active drug ('pacetin', 2nd generation cephalosporin). 3 g per day divided into 3 times via intravenous route until the day of discharge. After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days. |
| Group B (placebo) | Placebo comparator | Drug: PlaceboDuring the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge. After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- grade I Tokyo guideline for acute cholecystitis
- grade II Tokyo guideline for acute cholecystitis without the evidence of gallbladder perforation
Key exclusion criteria (11 listed)
- chronic cholecystitis
- gallbladder polyp or gallbladder cancer
- the patient who underwent reduced port surgery
- the patient who underwent common bile duct exploration during the operation
- the patient who underwent concurrent operation
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 |
|---|---|---|
| CephalosporinAlso: 'Pacetin'During the hospitalization, intake of pacetin, 2nd generation cephalosporin. 3 g per day divided into 3 times via intravenous route until the day of discharge. After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days. | Drug | Group A (cephalosporin) |
| PlaceboAlso: normal saline and vitamin CDuring the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge. After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days. | Drug | Group B (placebo) |
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 antibiotics or placebo
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
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Cholecystitis
Not yet recruitingObservational study
SnapChole: An International, Time-Bound Prospective Platform Study of Management Strategies and Outcomes in Acute Calculous Cholecystitis
Cholecystitis, Acute
Not yet recruiting
Percutaneous Drainage Versus EUS-guided Gallbladder Drainage in Poor Surgical Patients With Cholecystitis
Cholecystitis, Acute
RecruitingObservational study
Influence of Gut Microbiome in Gallstone Disease
Gall Stone, Gall Stones, Common Bile Duct
Recruiting
Repeat Biliary Point of Care Ultrasound for Detecting Early Acute Cholecystitis
Cholecystitis, Acute, Biliary Diseases
Not yet recruiting
Implementation of RICA (ERAS) Guidelines in Grade II Acute Cholecystitis Undergoing Early Laparoscopic Cholecystectomy
Cholecystitis, Acute, Cholecystectomy, Laparoscopic
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.
Taeho Hong principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cephalosporin in people with Acute Cholecystitis, run by Taeho Hong 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 2 inclusion and 11 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: finished, as of the sponsor's last update on 7 Apr 2017. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 7 Apr 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 7 Apr 2017.