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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010583
Receipt No. 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

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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
Email 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
Email hmnsj175@m.ehime-u.ac.jp

Sponsor
Institute Hepato-biliary-pancreatic and Breast Surgery, Ehime University Graduate School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012362

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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