UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053741 |
|---|---|
| Receipt number | R000061326 |
| Scientific Title | A Comparative Study of Retroperitoneal Robotic and Pincer Laparoscopic Right Hemicolectomies with D3 Lymph Node Dissection |
| Date of disclosure of the study information | 2024/03/01 |
| Last modified on | 2024/02/29 20:30:59 |
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Basic information
Public title
A Comparative Study of Retroperitoneal Robotic and Pincer Laparoscopic Right Hemicolectomies with D3 Lymph Node Dissection
Acronym
Comparison of Robotic and Laparoscopic Right Hemicolectomy
Scientific Title
A Comparative Study of Retroperitoneal Robotic and Pincer Laparoscopic Right Hemicolectomies with D3 Lymph Node Dissection
Scientific Title:Acronym
Comparison of Robotic and Laparoscopic Right Hemicolectomy
Region
| Japan |
Condition
Condition
Cecal, ascending, and Transverse colon cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Our primary aim is to discern whether robotic right-sided colectomy can offer a better short-term outcome for cancer patients compared to the laparoscopic procedure. To begin our investigation, we initiated a retrospective comparison of lymph node dissection in robotic surgery versus that in laparoscopic surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative complication
Key secondary outcomes
The number of dissected lymph nodes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
In our study, we meticulously examined the medical records of 265(261?) consecutive patients who were diagnosed with right-sided colon cancer, which included cecal cancer, ascending colon cancer, and transverse colon cancer. These patients underwent surgical procedures including ileocecal resection, right hemicolectomy, or extended right hemicolectomy using either robotic or laparoscopic techniques.
Key exclusion criteria
Patients who meet inclusion criteria above.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Yanagita |
Organization
Nagoay City University
Division name
Gastroenterological Surgery
Zip code
4678602
Address
1 Kawasumi Mizuho-cho Mizuho ward Nagoya City Aichi prefecture
TEL
052-853-8226
tyanagi@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Secretary |
| Middle name | |
| Last name | GI surgery |
Organization
Nagoya City University
Division name
Gastroenterological Surgery
Zip code
4678602
Address
1 Kawasumi Mizuho-cho Mizuho ward Nagoya City Aichi prefecture
TEL
052-853-8226
Homepage URL
gesurgery.secretary@gmail.com
Sponsor or person
Institute
Takeshi Yanagita, gastroenterological surgery, Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya City University
Address
1 Kawasumi Mizuho-cho Mizuho ward Nagoya City
Tel
052-851-5511
tyanagi@med.nagoya-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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
265
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 02 | Month | 29 | Day |
Last modified on
| 2024 | Year | 02 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061326
