UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053839 |
|---|---|
| Receipt number | R000061288 |
| Scientific Title | Short term outcomes of Randomized Controlled Trial of Senhance Digital Laparoscopy System versus Laparoscopic colectomy for colon cancer |
| Date of disclosure of the study information | 2024/03/16 |
| Last modified on | 2024/03/12 17:40:13 |
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Basic information
Public title
Short term outcomes of Randomized Controlled Trial of Senhance Digital Laparoscopy System versus Laparoscopic colectomy for colon cancer
Acronym
Short term outcomes of randomized controlled trial of SenhanceDigitalLaparoscopySystem versus Laparoscopic colectomy for colon cancer
Scientific Title
Short term outcomes of Randomized Controlled Trial of Senhance Digital Laparoscopy System versus Laparoscopic colectomy for colon cancer
Scientific Title:Acronym
Short term outcomes of Randomized Controlled Trial of Senhance Digital Laparoscopy System versus Laparoscopic colectomy for colon cancer
Region
| Japan |
Condition
Condition
colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Short term outcomes
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative complications
Key secondary outcomes
Operarive times, blood loss, intraoperative complications, conversion rate, postoperative stays, pathlogical findings
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Senhance digital laparoscopy system
Interventions/Control_2
Laparoscopic surgery
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases with Informed Consent
Clinical stage 0-3 adenocarcinoma
Radical surgery is planned
Tumor site in cecum, ascending colon, sigmoid colon, or sigmoid rectum
Tumor length 4-0 cm or less
Patient age 20-80 years
Performance status ECOG 0-1.
No previous gastrointestinal surgery other than appendectomy
No organ dysfunction or hematologic abnormality
Key exclusion criteria
Multiple cancers
Active infectious disease
Previous psychiatric and/or central nervous system disorders
Pregnancy, lactation, or possible pregnancy
Serious concomitant illness (cardiopulmonary dysfunction, renal failure, intestinal paralysis, intestinal obstruction, uncontrolled disease, etc.)
(intestinal paralysis, intestinal obstruction, uncontrolled diabetes, renal failure, cirrhosis, chronic hepatitis B, chronic hepatitis C, etc.)
No history of organ transplantation
Receiving preoperative treatment for colorectal cancer (chemotherapy, radiation therapy, hormonal therapy, etc.)
Patients deemed unsuitable for study enrollment by the investigator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yasuhio |
| Middle name | |
| Last name | Ishiyama |
Organization
Saitama medical University Internatinal medical center
Division name
Gastroenterological surgery
Zip code
3501241
Address
1397-1 Yamane Hidaka city Saitama prefectual 350-1241
TEL
0429844111
cesarishimar1215@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Ishiyama |
Organization
Saitama medical university international medical center
Division name
Gastroenterological surgery
Zip code
3501241
Address
1397-1 Yamane Hidaka city Saitama prefectual 350-1241
TEL
0429844111
Homepage URL
cesarishimar1215@yahoo.co.jp
Sponsor or person
Institute
Saitama medical university international medical center
Institute
Department
Personal name
Funding Source
Organization
Saitama medical university international medical center
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
Saitama medical university international medical center
Address
1397-1, Yamane,Hidaka city,Saitama prefectual 350-1241
Tel
0429844111
cesarishimar1215@yahoo.co.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
| 2024 | Year | 03 | Month | 16 | 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
| 2024 | Year | 03 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 12 | Day |
Last modified on
| 2024 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061288
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
