UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Single-incision laparoscopic cholecystectomy vs. needlescopic cholecystectomy; which is better for both surgeons and patients?
Title of the study (Brief title)	Single-incision laparoscopic cholecystectomy vs. needlescopic cholecystectomy
Region	Japan

Condition
Condition	benign gallbladder diseases
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the surgical outcome for surgeons and postoperative pain and cosmetic outcome for patients between SILC and NSC.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The variables analyzed included age, sex, body mass index, operating time, blood loss, analgesic requirements, resumption of oral intake, length of hospital stay, postoperative complications, incisional pain scores, and cosmetic satisfaction scores.
Key secondary outcomes	Learning curve of the surgeon

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Sinlge incision laparoscopic cholecystectomy
Interventions/Control_2	Needlescopic 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	18 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	preoperative diagnosis of symptomatic cholelithiasis or gallbladder polyps scheduled for elective cholecystectomy at the Morioka Municipal Hospital in Morioka city, Japan,
Key exclusion criteria	(1) American Society of Anesthesiologists class IV and V; (2) general contraindication for laparoscopic surgery under pneumoperitoneum; (3) patients with Mirizzi syndrome; (4) patients with suspected malignancy; (5) patients with suspected presence of choledocholithiasis; (6) Grade III acute cholecystitis in Tokyo guidelines.
Target sample size	100

Research contact person
Name of lead principal investigator	Umemura Akira
Organization	Morioka Municipal Hospital
Division name	Department of Surgery
Address	5-15-1 Motomiya, Morioka
TEL	019-635-0101
Email	auau001@hotmail.com

Public contact
Name of contact person	Umemura Akira
Organization	Morioka Municipal Hospital
Division name	Department of Surgery
Address	5-15-1 Motomiya, Morioka
TEL	019-635-0101
Homepage URL
Email	auau001@hotmail.com

Sponsor
Institute	Morioka Municipal Hospital Department of Surgery
Institute
Department

Funding Source
Organization	Morioka Municipal Hospital
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 19 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 01 Day
Anticipated trial start date	2015 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.karger.com/Article/Abstract/486455
Results
Other related information

Management information
Registered date	2016 Year 05 Month 19 Day
Last modified on	2018 Year 08 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025773