UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012654 |
|---|---|
| Receipt number | R000014694 |
| Scientific Title | Early versus early interval laparoscopic cholecystectomy for acute cholecystitis, a prospective randomized controlled trial |
| Date of disclosure of the study information | 2013/12/24 |
| Last modified on | 2013/12/23 11:38:13 |
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Basic information
Public title
Early versus early interval laparoscopic cholecystectomy for acute cholecystitis, a prospective randomized controlled trial
Acronym
Early versus early interval laparoscopic cholecystectomy for acute cholecystitis, a prospective randomized controlled trial
Scientific Title
Early versus early interval laparoscopic cholecystectomy for acute cholecystitis, a prospective randomized controlled trial
Scientific Title:Acronym
Early versus early interval laparoscopic cholecystectomy for acute cholecystitis, a prospective randomized controlled trial
Region
| Japan |
Condition
Condition
Acute cholecystitis
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the non-inferiority of early interval laparoscopic cholecystectomy for acute cholecystitis in terms of the operation time compared to early laparoscopic cholecystectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase III
Assessment
Primary outcomes
Operation time
Key secondary outcomes
(1) total operation time
(2) specific operation time
(3) intraoperative blood loss
(4) rate of conversion from laparoscopic to open cholecystectomy
(5) morbidity
(6) major bile duct injury
(7) injury of gallbladder wall
(8) decomplession of gallbladder
(9) using of closed suction drainage
(10) length of postoperative hospital stay
(11) length of total hospital stay
(12) total cost of admission
(13) subjective difficulty of the operation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
In the early group, patients undergo laparoscopic cholecystectomy within 72 h of admission.
Interventions/Control_2
In the early interval group, patients are treated with intravenous fluids and antibiotics until inflammation diminish (defined as the day of improvement). An elective laparoscopic cholecystectomy is scheduled within 7 d after the day of improvement.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 200 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Patients referred to our outpatient with a diagnosis of acute cholecystitis
(2) With a possibility of laparoscopic cholecystectomy within 72h after admission
(3) Written informed consent
Key exclusion criteria
(1) Sever cholecystitis (Based on TG13)
(2) ASA (American society of anesthesiologists) physical status 4 and 5
(3) perforation or abcess of the gallbladder
(4) co-existing common bile duct stones
(5) previous upper abdominal surgery
(6) life expectancy less than 48h
(7) pregnancy or breastfeeding
(8) contraindications against the antibiotic (PIPC/TZB) used in this trial
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masao Nakajima |
Organization
Yawatahama city general hospital
Division name
Surgery
Zip code
Address
1-638 Oohira, Ehime 796-8502, Japan
TEL
0894-22-3211
masao_yamasui@msn.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masao Nakajima |
Organization
Yawatahama city general hospital
Division name
Surgery
Zip code
Address
1-638 Oohira, Ehime 796-8502, Japan
TEL
0894-22-3211
Homepage URL
masao_yamasui@msn.com
Sponsor or person
Institute
Yawatahama city general hospital
Institute
Department
Personal name
Funding Source
Organization
Yawatahama city general hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
市立八幡浜総合病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 12 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2013 | Year | 12 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 25 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 25 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 25 | Day |
Date analysis concluded
| 2016 | Year | 04 | Month | 15 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 12 | Month | 23 | Day |
Last modified on
| 2013 | Year | 12 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014694
