UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058932 |
|---|---|
| Receipt number | R000067155 |
| Scientific Title | Robotic Lateral versus Medial Approach for Left-Sided Colorectal Cancer: A Multicenter Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/08/29 |
| Last modified on | 2025/08/29 16:32:09 |
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Basic information
Public title
Robotic Lateral versus Medial Approach for Left-Sided Colorectal Cancer: A Multicenter Randomized Controlled Trial
Acronym
RoLAT Study
Scientific Title
Robotic Lateral versus Medial Approach for Left-Sided Colorectal Cancer: A Multicenter Randomized Controlled Trial
Scientific Title:Acronym
RoLAT Study
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate, in a multicenter randomized phase III trial, whether the lateral approach shortens mesocolic dissection time compared with the medial approach in robotic-assisted surgery for left-sided colorectal cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time from the initiation of medial or lateral peritoneal incision to the completion of mesocolic mobilization, including central vascular ligation.
Key secondary outcomes
1.Surgical outcomes
Operative time (minutes)
Dissection time (minutes)
Blood loss (mL)
Intraoperative complications (yes/no)
Conversion rate to laparoscopic or open surgery
Quality of dissection (video assessment)
2. Postoperative course
Postoperative hospital stay (days)
Postoperative complications within 30 days (Clavien Dindo classification)
Readmission within 30 days (yes/no)
Reoperation within 30 days (yes/no)
3.Long term outcomes
Recurrence (yes/no)
Site of recurrence
Time to recurrence (months from surgery)
Survival status (overall survival, recurrence free survival)
4.Learning curve evaluation
Changes in operative time and dissection time according to case sequence for each surgeon
Analysis using CUSUM method
5.Surgeon stress assessment
Evaluated immediately after surgery using the SURG TLX questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Patients undergoing robotic-assisted left-sided colorectal cancer surgery using the lateral approach, in which mesocolic dissection is initiated by incising the lateral peritoneum.
Interventions/Control_2
Patients undergoing robotic-assisted left-sided colorectal cancer surgery using the medial approach, in which mesocolic dissection is initiated near the central vessels.
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 scheduled to undergo robotic-assisted colorectal resection with D3 lymphadenectomy (including high ligation of the inferior mesenteric artery) for sigmoid colon cancer or rectal cancer (or suspected cases).
2) Patients with a clinical tumor depth of cT1 to cT3.
3) Patients with an ECOG Performance Status of 0 to 2.
4) Patients who are willing to participate in this study, have provided written informed consent, and are 20 years of age or older at the time of consent.
Key exclusion criteria
1. Pregnant or breastfeeding patients, or those with a possibility of pregnancy
2. Patients in whom lymph node dissection is not performed
3. Patients diagnosed with multiple colorectal cancers
4. Patients with a history of colorectal resection
5. Patients diagnosed preoperatively with bowel obstruction, perforation, or penetration
6. Patients diagnosed preoperatively with PDM
7. Patients scheduled for robot-assisted surgery but converted preoperatively to open or laparoscopic surgery
8. Patients whose consent cannot be obtained due to inability to confirm their own will (e.g., dementia, impaired consciousness)
9. Patients with poorly controlled diabetes mellitus
10. Patients with unstable angina (angina pectoris that developed within the past 3 weeks or has worsened recently) or a history of myocardial infarction within the past 6 months
11. Patients with poorly controlled valvular disease, dilated cardiomyopathy, or hypertrophic cardiomyopathy
12. Patients receiving continuous systemic administration of steroids or other immunosuppressive drugs
13. Patients with a history of chemotherapy or radiotherapy
14. Any other patients deemed unsuitable for participation in this study by the principal investigator or co-investigators
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Takahisa |
| Middle name | |
| Last name | Hirokawa |
Organization
Kariya Toyota General Hospital
Division name
Department of Gastrointestinal Surgery
Zip code
448-8505
Address
Kariya Toyota General Hospital 5-15 Sumiyoshi-cho, Kariya City, Aichi 448-8505, Japan
TEL
0566-25-2950
inakin1208inakin@gmail.com
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Fujii |
Organization
Kariya Toyota General Hospital
Division name
Department of Gastrointestinal Surgery
Zip code
448-8505
Address
5-15 Sumiyoshi-cho, Kariya City, Aichi 448-8505, Japan
TEL
0566-25-2950
Homepage URL
inakin1208inakin@gmail.com
Sponsor or person
Institute
Department of Gastrointestinal Surgery, Kariya Toyota General Hospital
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
Nagoya City University West Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kariya Toyota General Hospital
Address
Department of Gastrointestinal Surgery, Kariya Toyota General Hospita
Tel
0566-21-2450
inakin1208inakin@gmail.com
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
刈谷豊田総合病院（愛知県） 名古屋市立大学付属西部医療センター（愛知県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 08 | Month | 29 | 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
| 2025 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2031 | 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
| 2025 | Year | 08 | Month | 29 | Day |
Last modified on
| 2025 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067155
