Rectal CancerNCT06814093
Robotic Versus Laparoscopic Surgery for Middle and Low Rectal Cancer: a Target Trial Emulation
An observational study of Rectal Cancer, run by Xu jianmin at 1 site in China.
Trial summary
This study aims to compare the effectiveness of robotic surgery versus laparoscopic surgery in treating low rectal cancer. While robotic surgery has gained popularity, there is limited long-term evidence regarding its outcomes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Robotic surgery and Laparoscopic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 2,702 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 30 Apr 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The data is sourced from the Colorectal Cancer Specialty Cohort Database and Biobank, established through the "Construction and Application of the Shanghai Colorectal Cancer Specialty Cohort Database and Biobank" project. The research will utilize cohort data collected from January 2021 to May 2022 (17 months). This specialized database was led by Zhongshan Hospital, Fudan University, in collaboration with Shanghai Tenth People's Hospital, Fudan University Shanghai Cancer Center, First Affiliated Hospital of Naval Medical University (Changhai Hospital), Renji Hospital, Shanghai Jiao Tong University School of Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, and Shanghai First People's Hospital.
Who may be able to join
- Age from 18 years to 80 years;
- American Society of Anesthesiologists (ASA) class I - III;
- Histologically proved rectal adenocarcinoma;
- Inferior tumor edge ≤ 10 cm from anal verge, measured by rigid rectoscopy;
- Tumor assessed as cT1-T3 (mesorectal fascia not involved) N0-1, or ycT1-T3 Nx after preoperative radio- or chemoradiotherapy, measured by pelvic MRI;
- No evidence of distant metastases (including pelvis, peritoneum, liver, lung, brain, bone, distant lymph node, etc), according to ultrasound, CT, MRI, PET-CT, etc;
Show all 9Show fewer
- No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri;
- Received either robotic or laparoscopic surgery; 9） Surgery with radical intent;
- 10) Informed consent.
Who cannot join
- Emergency surgery for acute intestinal obstruction, bleeding, perforation, etc;
- Synchronous colon surgery for multiple colorectal tumors or other schedules;
- Hereditary colorectal cancer (familial adenomatosis polyposis, Lynch Syndrome, etc.);
- Co-existent inflammatory bowel disease;
- Pregnancy or lactation;
- Patients received treatment other than preoperative radio- or chemoradiotherapy.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital, Fudan University, Shanghai, China
Shanghai, Shanghai Municipality, 200000
About this study
Official title: Robotic Versus Laparoscopic Surgery for Middle and Low Rectal Cancer: A Retrospective Cohort Study Emulating the Target Trial
This study aims to compare the effectiveness of robotic surgery versus laparoscopic surgery in treating low rectal cancer. While robotic surgery has gained popularity, there is limited long-term evidence regarding its outcomes. By using real-world data from a specialized multicenter colorectal cancer database in Shanghai, China, this retrospective cohort study will emulate the target trial to evaluate whether robotic surgery offers advantages over laparoscopic surgery. Key factors such as disease-free survival, locoregional recurrence, circumferential margin positivity, and postoperative complications will be examined. The goal is to provide stronger, evidence-based support for the clinical use of robotic surgery in treating low rectal cancer.
- Conditions
- Rectal Cancer
- Being tested
- Robotic surgery, Laparoscopic surgery
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic surgeryProcedure or surgery
Robotic surgery for radical resection of middle and low rectal cancer
Laparoscopic surgeryProcedure or surgery
Laparoscopic surgery for radical resection of middle and low rectal cancer
| Study group | Role | What they receive |
|---|---|---|
| Robotic group | Patients received robotic surgery for middle and low rectal cancer Receives: Procedure: Robotic surgery | |
| Laparoscopic group | Patients received laparoscopic surgery for middle and low rectal cancer Receives: Procedure: Laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year postoperative disease-free survival rate
Disease-free survival event is defined as any death or locoregional recurrence or distant metastases.
Measured: From surgery to three years postoperatively
Secondary outcomes (4)
Circumferential resection margin positivity rate
Circumferential resection margin positivity is defined as 1 mm or less from the tumor.
Measured: 14 days during postoperative pathological examination
30-day postoperative complication rate (Clavien-Dindo grade 2 or higher grade)
30-day postoperative complication rate is defined according to the Clavien-Dindo grade system. Only complications in grade 2 or higher grade will be calculated.
Measured: From surgery to 30 days postoperatively
rate of abdominoperineal resection
percentage of patients received abdominoperineal resection
Measured: 30 days after surgery
3-year postoperative locoregional recurrence rate
Locoregional recurrence is defined as any cancer recurrence in the pelvic or perineal area.
Measured: From surgery to three years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 Jan 2021
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,702 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xu jianmin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xu jianmin, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814093
- Sponsor's protocol ID
- CCS-DASET-TTE-REAL
- Status last verified
- May 2025
- First submitted
- 3 Feb 2025
- Last updated
- 9 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Versus Laparoscopic Surgery for Middle and Low Rectal Cancer: A Retrospective Cohort Study Emulating the Target Trial
- ClinicalTrials.gov ID
- NCT06814093
- Acronym / sponsor ID
- CCS-DASET-TTE-REAL
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,702 participants (actual)
- Lead sponsor
- Xu jianminUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the effectiveness of robotic surgery versus laparoscopic surgery in treating low rectal cancer. While robotic surgery has gained popularity, there is limited long-term evidence regarding its outcomes. By using real-world data from a specialized multicenter colorectal cancer database in Shanghai, China, this retrospective cohort study will emulate the target trial to evaluate whether robotic surgery offers advantages over laparoscopic surgery. Key factors such as disease-free survival, locoregional recurrence, circumferential margin positivity, and postoperative complications will be examined. The goal is to provide stronger, evidence-based support for the clinical use of robotic surgery in treating low rectal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic group | – | Procedure: Robotic surgeryPatients received robotic surgery for middle and low rectal cancer |
| Laparoscopic group | – | Procedure: Laparoscopic surgeryPatients received laparoscopic surgery for middle and low rectal cancer |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The data is sourced from the Colorectal Cancer Specialty Cohort Database and Biobank, established through the "Construction and Application of the Shanghai Colorectal Cancer Specialty Cohort Database and Biobank" project. The research will utilize cohort data collected from January 2021 to May 2022 (17 months). This specialized database was led by Zhongshan Hospital, Fudan University, in collaboration with Shanghai Tenth People's Hospital, Fudan University Shanghai Cancer Center, First Affiliated Hospital of Naval Medical University (Changhai Hospital), Renji Hospital, Shanghai Jiao Tong University School of Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, and Shanghai First People's Hospital.
Key inclusion criteria (9 listed)
- Age from 18 years to 80 years;
- American Society of Anesthesiologists (ASA) class I - III;
- Histologically proved rectal adenocarcinoma;
- Inferior tumor edge ≤ 10 cm from anal verge, measured by rigid rectoscopy;
- Tumor assessed as cT1-T3 (mesorectal fascia not involved) N0-1, or ycT1-T3 Nx after preoperative radio- or chemoradiotherapy, measured by pelvic MRI;
Key exclusion criteria (6 listed)
- Emergency surgery for acute intestinal obstruction, bleeding, perforation, etc;
- Synchronous colon surgery for multiple colorectal tumors or other schedules;
- Hereditary colorectal cancer (familial adenomatosis polyposis, Lynch Syndrome, etc.);
- Co-existent inflammatory bowel disease;
- Pregnancy or lactation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic surgeryRobotic surgery for radical resection of middle and low rectal cancer | Procedure or surgery | Robotic group |
| Laparoscopic surgeryLaparoscopic surgery for radical resection of middle and low rectal cancer | Procedure or surgery | Laparoscopic group |
Primary outcome
3-year postoperative disease-free survival rate
Time frame: From surgery to three years postoperatively
Disease-free survival event is defined as any death or locoregional recurrence or distant metastases.
4 secondary outcomes
Circumferential resection margin positivity rate
Time frame: 14 days during postoperative pathological examination
30-day postoperative complication rate (Clavien-Dindo grade 2 or higher grade)
Time frame: From surgery to 30 days postoperatively
rate of abdominoperineal resection
Time frame: 30 days after surgery
3-year postoperative locoregional recurrence rate
Time frame: From surgery to three years postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by Xu jianmin at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year postoperative disease-free survival rate (time frame: From surgery to three years postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2025.