UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041565 |
|---|---|
| Receipt number | R000046673 |
| 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 |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2020/08/26 22:22:42 |
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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
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
shogot@yokohama-cu.ac.jp
Sponsor or person
Institute
Gastroenterological Center, Yokohama City University Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046673
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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