UMIN-CTR Clinical Trial

Basic information
Public title	Retrospective study of the proportion of working hours associated with bleeding in laparoscopic rectal resection.
Acronym	Retrospective study of the proportion of working hours associated with bleeding in laparoscopic rectal resection.
Scientific Title	Retrospective study of the proportion of working hours associated with bleeding in laparoscopic rectal resection.
Scientific Title:Acronym	Retrospective study of the proportion of working hours associated with bleeding in laparoscopic rectal resection.
Region	Japan

Condition
Condition	Rectal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To analyze required times of surgical process in detail especially bleeding and hemostasis from surgery video in patients who performed laparoscopic low anterior resection for rectal cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The proportion of working hours associated with bleeding in laparoscopic operation
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	For patients who meet all of the following criteria. 1) 20 years or older at surgical time with no age limit. 2) Regardless of gender. 3) Patients who underwent laparoscopic low anterior resection for rectal cancer diagnosed adenocarcinoma pathologically. 4) Regardless with or without distant metastasis. 5) Regardless with or without preoperative therapy (chemotherapy, radiotherapy, chemoradiotherapy).
Key exclusion criteria	Exclude patients who meet any of the following criteria. 1) Emergency surgery cases. 2) Patients determined to be inappropriate by the doctor's judgement.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Jun Middle name Last name Watanabe
Organization	Yokohama City University Medical Center
Division name	Gastroenterological Center
Zip code	232-0024
Address	4-57 Urafune-cho, Minami-ku, Yokohama city, Kanagawa prefecture, Japan
TEL	045-261-5656
Email	nabe-jun@comet.ocn.ne.jp

Public contact
Name of contact person	1st name Koki Middle name Last name Goto
Organization	Yokohama City University Medical Center
Division name	Gastroenterological Center
Zip code	232-0024
Address	4-57 Urafune-cho, Minami-ku, Yokohama city, Kanagawa prefecture, Japan
TEL	045-261-5656
Homepage URL
Email	kouki_go_to@yahoo.co.jp

Sponsor
Institute	Yokohama City University
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	Yokohama City University Center for Novel and Exploratory Clinical Trials
Address	1-1-1 Fukuura, Kanazawa-ku, Yokohama city, Kanagawa prefecture, Japan
Tel	045-370-7933
Email	ynext@yokohama-cu.ac.jp

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	2020 Year 03 Month 23 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	Enrolling by invitation
Date of protocol fixation	2019 Year 11 Month 15 Day
Date of IRB	2019 Year 11 Month 19 Day
Anticipated trial start date	2019 Year 11 Month 19 Day
Last follow-up date	2023 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2020 Year 03 Month 22 Day
Last modified on	2021 Year 09 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044542