UMIN-CTR Clinical Trial

Public title

Is robotic surgery safe and effective for advanced (T4) colorectal cancer? A multicenter retrospective study

Acronym

Robotic surgery for T4 colorectal cancer study

Scientific Title

Robotic Surgery for pT4 Colorectal Cancer Is Safe and Oncologically Non-Inferior: A Multicenter Retrospective Study

Scientific Title:Acronym

pT4-ROBOT study

Region

Japan

Condition

Pathologically confirmed T4 colorectal cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the perioperative safety and minimal invasiveness of robotic-assisted surgery compared with laparoscopic and open surgery in pT4 colorectal cancer.

Basic objectives2

Others

Basic objectives -Others

To compare long-term oncologic outcomes (OS/DFS) across surgical approaches and assess whether outcomes with robotic surgery are comparable to those with laparoscopic/open surgery.

Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

Postoperative complications(Clavien-Dindo grade>=2)

Key secondary outcomes

conversion to open surgery; Operative time; estimated blood loss; postoperative length of stay; overall survival (OS); disease-free survival (DFS).

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who underwent curative-intent resection between 2016-01-01 and 2024-12-31 at the 7 participating institutions.
Pathologically confirmed pT4 colorectal cancer (colon or rectum). Surgical approach: robotic-assisted, laparoscopic, or open.
Essential perioperative and follow-up data available for analysis.

Key exclusion criteria

Stage IV disease (distant metastasis), R2 resection, Synchronous or metachronous multiple colorectal cancers, Stoma creation only without resection of the primary tumor

Recurrent tumors, Incomplete clinical data for key variables

Target sample size

427

Name of lead principal investigator

1st name	Kaido
Middle name
Last name	Oishi

Organization

National Hospital Organization Nagasaki Medical Center

Division name

Department of Surgery

Zip code

856-8562

Address

2-1001-1 Kubara, Omura, Nagasaki 856-8562, Japan

TEL

+81-957-52-3121

Email

kaido.ars@gmail.com

Name of contact person

1st name	Kaido
Middle name
Last name	Oishi

Organization

National Hospital Organization Nagasaki Medical Center

Division name

Department of Surgery

Zip code

856-8562

Address

2-1001-1 Kubara, Omura, Nagasaki 856-8562, Japan

TEL

+81-957-52-3121

Homepage URL

Email

kaido.ars@gmail.com

Institute

National Hospital Organization Nagasaki Medical Center

Institute

Department

Personal name

Organization

Funding organization: None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

The Clinical Research Review Board in Nagasaki University

Address

1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken 852-8501, Japan

Tel

+81-95-819-7229

Email

gaibushikin@ml.nagasaki-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2025

Year

10

Month

29

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

427

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

Recruitment status

Completed

Date of protocol fixation

2025

Year

04

Month

01

Day

Date of IRB

2020

Year

11

Month

17

Day

Anticipated trial start date

2025

Year

04

Month

01

Day

Last follow-up date

2025

Year

06

Month

14

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This is a multicenter retrospective observational cohort study (non-interventional, consecutive sampling) across seven institutions. Eligible patients underwent curative-intent resection between 2016 and 2024 and had pathologically confirmed pT4 colorectal cancer. Primary outcomes are postoperative complications within 30 days or during index hospitalization (Clavien-Dindo grade II or higher) and conversion to open surgery (robotic vs laparoscopic only). Secondary outcomes include operative time, estimated blood loss, postoperative length of stay, overall survival (OS), and disease-free survival (DFS). All consecutive eligible cases are included (target ~427 patients). No new enrollment or interventions are conducted; therefore, no additional participant risk is anticipated. The study was conducted under central IRB approval with opt-out consent on institutional websites; data were de-identified prior to analysis. This is a retrospective registration. No funding organization.

Registered date

2025

Year

10

Month

29

Day

Last modified on

2025

Year

10

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068138