UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010583 |
|---|---|
| Receipt number | R000012362 |
| Scientific Title | Randomized study comparing quality of life after single-port versus conventional 4-port laparoscopic cholecystectomy |
| Date of disclosure of the study information | 2013/04/26 |
| Last modified on | 2016/07/25 13:56:31 |
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Basic information
Public title
Randomized study comparing quality of life after single-port versus conventional 4-port laparoscopic cholecystectomy
Acronym
QOL after single-port vs 4-port laparoscopic cholecystectomy
Scientific Title
Randomized study comparing quality of life after single-port versus conventional 4-port laparoscopic cholecystectomy
Scientific Title:Acronym
QOL after single-port vs 4-port laparoscopic cholecystectomy
Region
| Japan |
Condition
Condition
symptomatic cholelithiasis, gallbladder polyp, adenomyomatosis
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Four-port laparoscopic cholecystectomy has been established to date as the standard surgery for benign gallbladder diseases. Meanwhile single-port laparoscopic cholecystectomy is recently spreading with its cosmetic advantage over conventional 4-port method. It is still uncertain as to whether or not single-port laparoscopic cholecystectomy has the superiority as a minimally invasive surgery besides cosmesis. Therefore, we planned randomized study to compare quality of life after both cholecystectomies.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to regain QOL (SF36 Role Physical ) after cholecystectomy
Key secondary outcomes
Postoperative pain, time to resume work, operative time, bleeding, hospital stay, complications, postoperative inflammatory response and liver function
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 considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Single-port laparoscopic cholecystectomy
Interventions/Control_2
Conventional 4-port 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1)Patients who need to undergo laparoscopic cholecystectomy for either symptomatic cholelithiasis, gallbladder polyp, or adenomyomatosis
(2)Patients who are over 20 years of age at the time of consent
Key exclusion criteria
(1) Acute cholecystitis corresponding to the moderate and severe grade
(2) Severe cirrhosis
(3) Suspected cases of gallbladder cancer
(4) When performing another operation concurrently
(5) Obesity (BMI:Body Mass Index over 35)
(6) Suspected cases of pregnancy
(7) Patients with mental disorder or dementia
(8) Patients who are judged ineligible by the investigator and the attending surgeon
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasutsugu Takada |
Organization
Ehime University Graduate School of Medicine
Division name
Hepato-biliary-pancreatic and Breast Surgery
Zip code
Address
Shitsukawa, Toon, Ehime, Japan
TEL
089-960-5327
takaday@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eitaro Ito |
Organization
Ehime University Graduate School of Medicine
Division name
Hepato-biliary-pancreatic and Breast Surgery
Zip code
Address
Shitsukawa, Toon, Ehime, Japan
TEL
089-960-5327
Homepage URL
hmnsj175@m.ehime-u.ac.jp
Sponsor or person
Institute
Hepato-biliary-pancreatic and Breast Surgery, Ehime University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hepato-biliary-pancreatic and Breast Surgery, Ehime University Graduate School of Medicine
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
愛媛大学医学部附属病院（愛媛県）、市立宇和島病院（愛媛県）、愛媛県立中央病院（愛媛県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 03 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
| 2015 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 24 | Day |
Last modified on
| 2016 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012362
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
