UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047670 |
|---|---|
| Receipt number | R000054353 |
| Scientific Title | Prospective interventional study on a side-to-side intracorporeal anastomosis with circular stapler for colon cancer |
| Date of disclosure of the study information | 2022/05/06 |
| Last modified on | 2022/12/27 22:47:29 |
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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
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
ahamabe@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
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
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
5
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Case 5
A patient with cancer of the ascending colon underwent laparoscopic right hemicolectomy and anastomosis using a circular stapler.
On postoperative day 33, a colonoscopy was performed, and a pinhole-like stenosis at the anastomosis was observed, requiring endoscopic balloon dilation.
This case was considered a serious adverse event and the study was terminated.
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
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 | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054353
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| Registered date | File name |
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| Registered date | File name |
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