UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002539 |
|---|---|
| Receipt number | R000003103 |
| Scientific Title | Randomized controlled trial to evaluate the superiority of the Single Port Chlecystectomy (SPC) on reduction of postoperative pain, compared with the conventional laparoscopic cholecystectomy at the single institution |
| Date of disclosure of the study information | 2009/09/24 |
| Last modified on | 2011/03/24 14:17:56 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Randomized controlled trial to evaluate the superiority of the Single Port Chlecystectomy (SPC) on reduction of postoperative pain, compared with the conventional laparoscopic cholecystectomy at the single institution
Acronym
Randomized controlled trial to evaluate the superiority of the Single Port Chlecystectomy (SPC)
Scientific Title
Randomized controlled trial to evaluate the superiority of the Single Port Chlecystectomy (SPC) on reduction of postoperative pain, compared with the conventional laparoscopic cholecystectomy at the single institution
Scientific Title:Acronym
Randomized controlled trial to evaluate the superiority of the Single Port Chlecystectomy (SPC)
Region
| Japan |
Condition
Condition
Patients undergoing cholecystectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this trial is to evaluate the surperiority of the Single port cholecystectomy on postoperative pain in cholecystectomy, compared with the conventional laparoscopic cholecystectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
pain score
Key secondary outcomes
Rate of the analgesic requirement, total operation time, cost of operation, blood examine, hospital stay
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Single Port Cholecystectomy
Interventions/Control_2
Conventional Laparoscopic Cholecystectomy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients, who are scheduled to undergo cholecystectomy at our institution, provide a written informed consent, and do not meet the below exclusion criteria.
Key exclusion criteria
1)Clinically-proven gallbladder cancer or choledocholithasis.
2)Cases with symptom caused by gallbladder
3)Serious coexisting illness
a; uncontrolled hypertension
b; history of myocardial infarction, unstable angina within 6 months prior to the registration
c; liver cirrhosis
d; severe pulmonary dysfunction
4) pregnant or nursing
5) severe mental disorders
6) not suitable for participating in the study for any other reason
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Asakuma |
Organization
Osaka Medical College
Division name
Depertment of General and Gastroenterological Surgery
Zip code
Address
2-7 Daigaku-machi, Takatsuki city Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Asakuma |
Organization
Osaka Medical College
Division name
Depertment of General and Gastroenterological Surgery
Zip code
Address
TEL
Homepage URL
sur105@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College, Depertment of General and Gastroenterological Surgery
Institute
Department
Personal name
Funding Source
Organization
none
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
大阪医科大学付属病院
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | 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
Completed
Date of protocol fixation
| 2009 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 24 | Day |
Last modified on
| 2011 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003103
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
