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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002539
Receipt No. 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

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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
Email

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
Email sur105@poh.osaka-med.ac.jp

Sponsor
Institute Osaka Medical College, Depertment of General and Gastroenterological Surgery
Institute
Department

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
Email

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
URL(English) https://upload.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


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