UMIN-CTR Clinical Trial

Basic information
Public title	A multicenter randomized controlled trial to evaluate the length of hospital stay of intracorporeal versus extracorporeal anastomosis in laparoscopic colectomy for colon cancer
Acronym	CONNECT study
Scientific Title	A multicenter randomized controlled trial to evaluate the length of hospital stay of intracorporeal versus extracorporeal anastomosis in laparoscopic colectomy for colon cancer
Scientific Title:Acronym	CONNECT study
Region	Japan

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

Objectives
Narrative objectives1	To examine the superiority of postoperative hospital stay for intracorporeal anastomosis in comparison to extracorporeal anastomosis.
Basic objectives2	Others
Basic objectives -Others	Comparing the anastomosis times of intracorporeal end-to-end anastomosis and intracorporeal side-to-side anastomosis.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Phase III

Assessment
Primary outcomes	length of postoperative stay
Key secondary outcomes	time required for anastomosis

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	intracorporeal end-to-end anastomosis
Interventions/Control_2	intracorporeal side-to-side anastomosis
Interventions/Control_3	extracorporeal anastomosis
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 preoperative histologically diagnosed colon cancer (including adenocarcinoma, squamous cell carcinoma, adenosquamous cell carcinoma, and neuroendocrine tumors) (2) Patients with tumors in the cecum, ascending colon, transverse colon, descending colon, or sigmoid colon and scheduled for laparoscopic colon resection. (3) Patients with a maximum tumor diameter of 8 cm or less (4) Patients with a preoperative clinical diagnosis of Stage I-III (5) Patients with ECOG Performance Status of grade 0 to 2
Key exclusion criteria	(1) Patients who have had a previous colorectal resection (2) Patients who are scheduled to undergo anastomosis with the Double Stapling Technique (3) Patients who are scheduled to have a stoma (or who will have a stoma remaining after the operation if it was already in place before the operation) (4) Patients with bowel obstruction (5) Patients scheduled to undergo simultaneous resection of multiple organs due to duplicate cancer (6) Patients scheduled to have more than one anastomosis due to multiple colorectal cancers. (7) Patients with active intra-abdominal infections (8) Patients with uncontrolled severe comorbidity (9) Other patients who are deemed by the attending physician to be unable to participate in the research.
Target sample size	300

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-shi, Kanagawa
TEL	045-261-5656
Email	jun0926@yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Shogo Middle name Last name Takei
Organization	Yokohama City University Medical Center
Division name	Gastroenterological Center
Zip code	232-0024
Address	4-57 Urafune-cho, Minami-ku, Yokohama-shi, Kanagawa
TEL	045-261-5656
Homepage URL
Email	shogot@yokohama-cu.ac.jp

Sponsor
Institute	Gastroenterological Center, Yokohama City University Medical Center
Institute
Department

Funding Source
Organization	MEDTRONIC JAPAN CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Clinical Trial Review Committee, Yokohama City University Hospital
Address	3-9 Fukuura, Kanazawa-ku, Yokohama-shi, 236-0004
Tel	045-787-2714
Email	chiken@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	横浜市立大学附属市民総合医療センター(神奈川県)、横浜市立大学附属病院(神奈川県)、横須賀共済病院(神奈川県)

Other administrative information
Date of disclosure of the study information	2020 Year 09 Month 01 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	Preinitiation
Date of protocol fixation	2020 Year 07 Month 12 Day
Date of IRB	2020 Year 08 Month 25 Day
Anticipated trial start date	2020 Year 09 Month 01 Day
Last follow-up date	2028 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 08 Month 26 Day
Last modified on	2020 Year 08 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046673