UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized study comparing quality of life after single-port versus conventional 4-port laparoscopic cholecystectomy
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yasutsugu Takada
Organization	Ehime University Graduate School of Medicine
Division name	Hepato-biliary-pancreatic and Breast Surgery
Address	Shitsukawa, Toon, Ehime, Japan
TEL	089-960-5327
Email	takaday@m.ehime-u.ac.jp

Public contact
Name of contact person	Eitaro Ito
Organization	Ehime University Graduate School of Medicine
Division name	Hepato-biliary-pancreatic and Breast Surgery
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

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 03 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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