UMIN-CTR Clinical Trial

Basic information
Public title	Long-term outcomes of laparoscopic versus open colectomy for highly advanced colon cancer patients
Acronym	Laparoscopic colectomy for highly advanced cancer
Scientific Title	Long-term outcomes of laparoscopic versus open colectomy for pathological T4 and/or N2 colon cancer patients: multicenter study using propensity-score matched analysis
Scientific Title:Acronym	Laparoscopic colectomy for pT4/N2 cancer
Region	Japan

Condition
Condition	colon cancer
Classification by specialty	Surgery in general Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Comparison of overall survival after laparoscopic or open surgery for highly advanced colon cancer
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall survival
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	100 years-old >=
Gender	Male
Key inclusion criteria	Non-metastatic patients with pT4 or pN2 colon cancers who underwent curative primary tumor resection between April 2016 and December 2020 at six hospitals (Ureshino Medical Center, Nagasaki University Hospital, Sasebo City General Hospital, Nagasaki Medical Center, Isahaya General Hospital and Saiseikai Nagasaki Hospital)
Key exclusion criteria	Patients with only stoma construction, emergency surgery, synchronous colon cancer, robotic surgery, and Stage IV disease
Target sample size	255

Research contact person
Name of lead principal investigator	1st name Shintaro Middle name Last name Hashimoto
Organization	Nagasaki University Hospital
Division name	Department of Surgical Oncology
Zip code	8528105
Address	1-7-1
TEL	0958197304
Email	s.hashi12@outlook.jp

Public contact
Name of contact person	1st name Shintaro Middle name Last name Hashimoto
Organization	Nagasaki University Hospital
Division name	Surgical oncology
Zip code	852-8105
Address	1-7-1, Sakamoto, Nagasaki City, Nagasaki, Japan
TEL	0958197304
Homepage URL
Email	s.hashi12@outlook.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

Funding Source
Organization	Nagasaki University Hospital
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	Nagasaki University Hospital
Address	1-7
Tel	0958197304
Email	s.hashi12@outlook.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	2022 Year 10 Month 04 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	255
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	Completed
Date of protocol fixation	2022 Year 10 Month 04 Day
Date of IRB	2016 Year 06 Month 27 Day
Anticipated trial start date	2022 Year 10 Month 04 Day
Last follow-up date	2022 Year 10 Month 04 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We compared the survival outcomes after laparoscopic or open surgery for colon cancer.

Management information
Registered date	2022 Year 10 Month 04 Day
Last modified on	2022 Year 10 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055944