UMIN-CTR Clinical Trial

Basic information
Public title	Prospective interventional study on a side-to-side intracorporeal anastomosis with circular stapler for colon cancer
Acronym	Prospective interventional study on a side-to-side intracorporeal anastomosis with circular stapler for colon cancer
Scientific Title	Prospective interventional study on a side-to-side intracorporeal anastomosis with circular stapler for colon cancer
Scientific Title:Acronym	Prospective interventional study on a side-to-side intracorporeal anastomosis with circular stapler for colon cancer
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the safety of intracorporeal anastomosis using a circular stapler for colon cancer
Basic objectives2	Others
Basic objectives -Others	Short-term outcomes including operative time, time for colon resection and reconstruction, and blood loss, and long-term outcomes including overall survival and recurrence rates
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Perioperative complication rates
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Comparison of short- and long-term outcomes in ileo-colon anastomosis or colon-colon anastomosis for colon cancer surgery between anastomoses with circular stapler and conventional linear stapler
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	(1) Patients with a preoperative histological diagnosis of colon cancer including adenocarcinoma, squamous cell carcinoma, adenosquamous carcinoma, and neuroendocrine tumor. (2) Patients who will undergo laparoscopic colectomy for colon cancer that is located on the cecum, ascending, transverse, descending, or sigmoid colon. (3) Patients whose tumor has a maximum diameter of 8 cm or less (4) Patients with a preoperative clinical diagnosis of Stage 0-III (5) ECOG Performance Status is 0-2. (6) Age 20 years or older (7) Written consent has been obtained.
Key exclusion criteria	(1) Patients who have undergone previous resection of colon or rectum. (2) Intestinal obstruction (3) Patients scheduled for simultaneous resection of multiple organs due to multiple cancers (4) Patients with to or more synchronous colorectal cancer that will require more than one anastomosis (5) Intra-abdominal infection (6) Uncontrollable serious comorbidity. (7) The study doctor deems that the patient is ineligible for this study. Translated with www.DeepL.com/Translator (free version)
Target sample size	15

Research contact person
Name of lead principal investigator	1st name Ichiro Middle name Last name Takemasa
Organization	Sapporo Medical University School of Medicine
Division name	Department of Surgery, Surgical Oncology and Science
Zip code	060-8543
Address	291 Minami-1-jo Nishi 16-chome, Chuo-ku, Sapporo City, Hokkaido, Japan
TEL	011-611-2111
Email	itakemasa@sapmed.ac.jp

Public contact
Name of contact person	1st name Atsushi Middle name Last name Hamabe
Organization	Sapporo Medical University School of Medicine
Division name	Department of Surgery, Surgical Oncology and Science
Zip code	060-8543
Address	291 Minami-1-jo Nishi 16-chome, Chuo-ku, Sapporo City, Hokkaido, Japan
TEL	011-611-2111
Homepage URL
Email	ahamabe@sapmed.ac.jp

Sponsor
Institute	Sapporo Medical University School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Sapporo Medical University School of Medicine
Address	291 Minami-1-jo Nishi 16-chome, Chuo-ku, Sapporo City, Hokkaido, Japan
Tel	011-611-2111
Email	ji-rskk <ji-rskk@sapmed.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	2022 Year 05 Month 06 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	2021 Year 09 Month 09 Day
Date of IRB	2021 Year 09 Month 09 Day
Anticipated trial start date	2021 Year 09 Month 09 Day
Last follow-up date	2028 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 05 Month 06 Day
Last modified on	2022 Year 05 Month 06 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054353

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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