Colon CancerNCT06421974
Effectiveness of Robotic Surgery for Right Colon Cancer
A study testing DaVinci si or xi system and laparoscopic radical resection in people with Colon Cancer and Robotic Surgery, run by Sir Run Run Shaw Hospital at 1 site in China.
Trial summary
This study aims to explore through a multi-center, randomized controlled clinical study whether robot-assisted radical resection of right colon cancer is superior to laparoscopic surgery in terms of surgical quality and oncological prognosis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colon Cancer, Robotic Surgery
- What is being tested?
- DaVinci si or xi system and laparoscopic radical resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 610 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 30 May 2027
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years old.
- ASA classification ≤ Level III.
- Colon adenocarcinoma was confirmed by colonoscopy and biopsy pathology.
- Transabdominal enhanced CT showed that the distal and proximal ends of the primary tumor were located in the right colon (cecum to the proximal 1/3 of the transverse colon).
- Preoperative clinical stage: TanyNanyM0.
- The patient's condition meets the indications for robotic surgery and is willing to accept the robotic surgery treatment plan.
- Voluntarily participate in this study and sign the informed consent form. If the subject is unable to read and sign the informed consent form due to incapacity or other reasons, his or her guardian must be responsible for the informed process and sign the informed consent form. If the subject is unable to read the informed consent form (such as illiterate subjects), a witness must witness the informed process and sign the informed consent form.
Who cannot join
- Preoperative examination indicates synchronous multiple primary colorectal cancers or other diseases requiring intestinal segmental resection.
- The results of preoperative imaging examination or intraoperative exploration suggest: 1) The tumor involves surrounding organs and requires combined organ resection; 2) There is distant metastasis; 3) R0 resection cannot be performed.
- Additional radical surgery after emr and esd surgery.
- Have a history of any other malignant tumor or familial adenomatous polyposis in the past 5 years, except for cured cervical carcinoma in situ, basal cell carcinoma, papillary thyroid carcinoma or cutaneous squamous cell carcinoma.
- Combined intestinal obstruction, intestinal perforation, intestinal bleeding, etc. require emergency surgery.
- Patients who are not suitable for or cannot tolerate robotic or laparoscopic surgery.
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- Pregnant or lactating women.
- Patients with a history of mental illness.
- Patients who have received neoadjuvant treatment before surgery.
- MDT discusses patients who are not suitable for entering the study.
- Patients who refuse to undergo either robotic or laparoscopic surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Trial of the Effectiveness of Robotic Versus Laparoscopic Surgery for Right Colon Cancer
This study aims to explore through a multi-center, randomized controlled clinical study whether robot-assisted radical resection of right colon cancer is superior to laparoscopic surgery in terms of surgical quality and oncological prognosis.
Read the detailed description
The incidence rate of colorectal cancer has risen to the second place in my country, highlighting its significant impact on public health. It is a high-incidence malignant tumor that seriously threatens the health of our people. Surgery is the core treatment method for curing colorectal cancer. With the promotion of multidisciplinary comprehensive treatment models, in-depth understanding of abdominal and pelvic anatomy, and innovations in surgical instruments and techniques, colorectal cancer surgery is gradually developing in the direction of minimally invasive and organ function preservation. This advancement not only improves the safety and effectiveness of surgery, but also improves patients' postoperative quality of life. Laparoscopic surgery has obvious minimally invasive advantages in the treatment of right colon cancer. Compared with traditional laparotomy, laparoscopic surgery has the advantages of less trauma, less postoperative pain, faster recovery, and shorter hospital stay.
Since Hohenberger proposed the concept of complete mesocolic excision (CME), the principle of CME has become a key technique in colon cancer surgery, which emphasizes thorough lymph node dissection and precise tumor resection. In radical resection of right colon cancer, CME technology ensures complete resection of surrounding tissue by performing surgery along the natural anatomical plane of blood vessels and nerve plexuses, thereby reducing the local recurrence rate of the tumor. A retrospective cohort study of 1395 cases included in the Danish Colorectal Cancer Study Group showed that the 4-year disease-free survival rate of patients of all stages after CME surgery was 85.8% (95% CI 81.4-90.1), and that after non-CME surgery, the 4-year disease-free survival rate was 85.8% (95% CI 81.4-90.1). The 4-year disease-free survival rate was 75.9% (95% CI 72.2-79.7) (log-rank p=0.0010), which preliminarily proved that the CME principle can significantly improve the disease recurrence-free survival (DFS) rate. This method aims to achieve better tumor cure results through more extensive and complete resection.
However, with the continuous innovation of surgical instruments and technologies, laparoscopic surgery is also facing some challenges. Laparoscopic surgery often provides a two-dimensional field of view, which may limit the surgeon's depth perception and accuracy when performing complex procedures. In addition, the operating rods of traditional laparoscopic tools are relatively long and the operating space is limited, which may lead to difficulties in gesture amplification and fine motor control during surgery, resulting in certain defects in surgical operation accuracy and visual field stability.
The robot-assisted surgical system provides a new technical platform for improving the quality of surgical operations with its enhanced visual capabilities, stable field of view and flexibility of surgical instruments. The stability of the three-dimensional stereo vision system and camera platform can significantly improve the surgical field of view, while the high flexibility of the robotic arm optimizes surgical operations. Existing clinical studies show that compared with traditional laparoscopic surgery, robot-assisted surgical systems have potential advantages in reducing the proportion of conversions to laparotomy, reducing the occurrence of postoperative complications, and shortening postoperative recovery time.
When considering the economic burden of robotic-assisted surgical systems relative to conventional laparoscopic surgery, more rigorous and quantitative evidence is necessary to assess their economic benefits in daily clinical practice. Although robot-assisted surgical systems offer operational advantages, their high equipment investment and maintenance costs remain a major obstacle to their adoption. Therefore, a comprehensive cost-effectiveness analysis, combined with an assessment of surgical outcomes, patient recovery, and long-term health-related quality, is critical to determine its suitability in the healthcare system. The REAL randomized controlled study led by Professor Xu Jianmin compared the surgical quality and long-term tumor prognosis of robot-assisted surgery and conventional laparoscopic surgery in patients with middle and low rectal cancer. The primary endpoint of the study was the 3-year local recurrence rate, while the secondary endpoints focused on the positive circumferential margin rate and the 30-day postoperative complication rate. The short-term secondary endpoint data that have been published so far are encouraging. However, there is still a lack of multicenter randomized controlled clinical studies on the long-term oncological outcomes of robotic surgery for right colon cancer.
This study aims to compare the 3-year disease recurrence-free survival (DFS) between robot-assisted radical right hemicolectomy (RA-LSRHC) and conventional laparoscopic radical right hemicolectomy (LSRHC) through a multicenter, randomized controlled study. The non-inferiority in terms of surgery provides high-quality evidence-based medical evidence for robot-assisted right colon cancer surgery, further optimizes treatment strategies, and improves patients' quality of life.
- Conditions
- Colon Cancer, Robotic Surgery
- Being tested
- DaVinci si or xi system, laparoscopic radical resection
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaVinci si or xi systemProcedure or surgery
In this study, subjects were randomly divided into an experimental group (robot-assisted radical resection of right colon cancer group, referred to as robotic surgery group) and a control group (laparoscopic radical resection of right colon cancer group, referred to as laparoscopic surgery group).
laparoscopic radical resectionProcedure or surgery
In this study, subjects were randomly divided into an experimental group (robot-assisted radical resection of right colon cancer group, referred to as robotic surgery group) and a control group (laparoscopic radical resection of right colon cancer group, referred to as laparoscopic surgery group).
| Study group | Role | What they receive |
|---|---|---|
| Robotic surgery for right colon cancer | Experimental | Robot-assisted right colon cancer radical resection group, referred to as robotic surgery group Receives: Procedure: DaVinci si or xi system |
| laparoscopic surgery for right colon cancer | Active comparator | Laparoscopic right colon cancer radical resection group, referred to as laparoscopic surgery group Receives: Procedure: laparoscopic radical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year disease-free survival rate
The time from randomization to first tumor recurrence/metastasis or death from any cause was defined as the time of last follow-up for patients lost to follow-up(Patients still alive at the end of the study, the end of follow-up).
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes (2)
30-day perioperative complications
Perioperative complications were classified according to the Clavien-Dindo system, including intraoperative, short-term and long-term postoperative complications.
Measured: up to 1 month.
Overall survival
5-year overall survival rate
Measured: 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2024
- Study start1 Jun 2024 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Sir Run Run Shaw HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 610 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sir Run Run Shaw Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Zhejiang Cancer Hospital, Zhejiang Provincial People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Ningbo No. 1 Hospital
- Responsible party
- Principal investigator, Zhangfa Song, Sir Run Run Shaw Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06421974
- Sponsor's protocol ID
- SRRS-ERSRCC
- Status last verified
- May 2024
- First submitted
- 3 May 2024
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Trial of the Effectiveness of Robotic Versus Laparoscopic Surgery for Right Colon Cancer
- ClinicalTrials.gov ID
- NCT06421974
- Acronym / sponsor ID
- SRRS-ERSRCC
- Conditions
- Colon Cancer, Robotic Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 610 participants (estimated)
- Lead sponsor
- Sir Run Run Shaw HospitalUniversity, hospital or other
- Collaborators
- Zhejiang University, Second Affiliated Hospital, Zhejiang University, School of Medicine, Zhejiang Cancer Hospital, Zhejiang Provincial People's Hospital, First Affiliated Hospital of Wenzhou Medical University, Ningbo No. 1 Hospital
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 20 May 2024 (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 explore through a multi-center, randomized controlled clinical study whether robot-assisted radical resection of right colon cancer is superior to laparoscopic surgery in terms of surgical quality and oncological prognosis.
Detailed description
The incidence rate of colorectal cancer has risen to the second place in my country, highlighting its significant impact on public health. It is a high-incidence malignant tumor that seriously threatens the health of our people. Surgery is the core treatment method for curing colorectal cancer. With the promotion of multidisciplinary comprehensive treatment models, in-depth understanding of abdominal and pelvic anatomy, and innovations in surgical instruments and techniques, colorectal cancer surgery is gradually developing in the direction of minimally invasive and organ function preservation. This advancement not only improves the safety and effectiveness of surgery, but also improves patients' postoperative quality of life. Laparoscopic surgery has obvious minimally invasive advantages in the treatment of right colon cancer. Compared with traditional laparotomy, laparoscopic surgery has the advantages of less trauma, less postoperative pain, faster recovery, and shorter hospital stay.
Since Hohenberger proposed the concept of complete mesocolic excision (CME), the principle of CME has become a key technique in colon cancer surgery, which emphasizes thorough lymph node dissection and precise tumor resection. In radical resection of right colon cancer, CME technology ensures complete resection of surrounding tissue by performing surgery along the natural anatomical plane of blood vessels and nerve plexuses, thereby reducing the local recurrence rate of the tumor. A retrospective cohort study of 1395 cases included in the Danish Colorectal Cancer Study Group showed that the 4-year disease-free survival rate of patients of all stages after CME surgery was 85.8% (95% CI 81.4-90.1), and that after non-CME surgery, the 4-year disease-free survival rate was 85.8% (95% CI 81.4-90.1). The 4-year disease-free survival rate was 75.9% (95% CI 72.2-79.7) (log-rank p=0.0010), which preliminarily proved that the CME principle can significantly improve the disease recurrence-free survival (DFS) rate. This method aims to achieve better tumor cure results through more extensive and complete resection.
However, with the continuous innovation of surgical instruments and technologies, laparoscopic surgery is also facing some challenges. Laparoscopic surgery often provides a two-dimensional field of view, which may limit the surgeon's depth perception and accuracy when performing complex procedures. In addition, the operating rods of traditional laparoscopic tools are relatively long and the operating space is limited, which may lead to difficulties in gesture amplification and fine motor control during surgery, resulting in certain defects in surgical operation accuracy and visual field stability.
The robot-assisted surgical system provides a new technical platform for improving the quality of surgical operations with its enhanced visual capabilities, stable field of view and flexibility of surgical instruments. The stability of the three-dimensional stereo vision system and camera platform can significantly improve the surgical field of view, while the high flexibility of the robotic arm optimizes surgical operations. Existing clinical studies show that compared with traditional laparoscopic surgery, robot-assisted surgical systems have potential advantages in reducing the proportion of conversions to laparotomy, reducing the occurrence of postoperative complications, and shortening postoperative recovery time.
When considering the economic burden of robotic-assisted surgical systems relative to conventional laparoscopic surgery, more rigorous and quantitative evidence is necessary to assess their economic benefits in daily clinical practice. Although robot-assisted surgical systems offer operational advantages, their high equipment investment and maintenance costs remain a major obstacle to their adoption. Therefore, a comprehensive cost-effectiveness analysis, combined with an assessment of surgical outcomes, patient recovery, and long-term health-related quality, is critical to determine its suitability in the healthcare system. The REAL randomized controlled study led by Professor Xu Jianmin compared the surgical quality and long-term tumor prognosis of robot-assisted surgery and conventional laparoscopic surgery in patients with middle and low rectal cancer. The primary endpoint of the study was the 3-year local recurrence rate, while the secondary endpoints focused on the positive circumferential margin rate and the 30-day postoperative complication rate. The short-term secondary endpoint data that have been published so far are encouraging. However, there is still a lack of multicenter randomized controlled clinical studies on the long-term oncological outcomes of robotic surgery for right colon cancer.
This study aims to compare the 3-year disease recurrence-free survival (DFS) between robot-assisted radical right hemicolectomy (RA-LSRHC) and conventional laparoscopic radical right hemicolectomy (LSRHC) through a multicenter, randomized controlled study. The non-inferiority in terms of surgery provides high-quality evidence-based medical evidence for robot-assisted right colon cancer surgery, further optimizes treatment strategies, and improves patients' quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic surgery for right colon cancer | Experimental | Procedure: DaVinci si or xi systemRobot-assisted right colon cancer radical resection group, referred to as robotic surgery group |
| laparoscopic surgery for right colon cancer | Active comparator | Procedure: laparoscopic radical resectionLaparoscopic right colon cancer radical resection group, referred to as laparoscopic surgery group |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18-75 years old.
- ASA classification ≤ Level III.
- Colon adenocarcinoma was confirmed by colonoscopy and biopsy pathology.
- Transabdominal enhanced CT showed that the distal and proximal ends of the primary tumor were located in the right colon (cecum to the proximal 1/3 of the transverse colon).
- Preoperative clinical stage: TanyNanyM0.
Key exclusion criteria (11 listed)
- Preoperative examination indicates synchronous multiple primary colorectal cancers or other diseases requiring intestinal segmental resection.
- The results of preoperative imaging examination or intraoperative exploration suggest: 1) The tumor involves surrounding organs and requires combined organ resection; 2) There is distant metastasis; 3) R0 resection cannot be performed.
- Additional radical surgery after emr and esd surgery.
- Have a history of any other malignant tumor or familial adenomatous polyposis in the past 5 years, except for cured cervical carcinoma in situ, basal cell carcinoma, papillary thyroid carcinoma or cutaneous squamous cell carcinoma.
- Combined intestinal obstruction, intestinal perforation, intestinal bleeding, etc. require emergency surgery.
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 |
|---|---|---|
| DaVinci si or xi systemIn this study, subjects were randomly divided into an experimental group (robot-assisted radical resection of right colon cancer group, referred to as robotic surgery group) and a control group (laparoscopic radical resection of right colon cancer group, referred to as laparoscopic surgery group). | Procedure or surgery | Robotic surgery for right colon cancer |
| laparoscopic radical resectionIn this study, subjects were randomly divided into an experimental group (robot-assisted radical resection of right colon cancer group, referred to as robotic surgery group) and a control group (laparoscopic radical resection of right colon cancer group, referred to as laparoscopic surgery group). | Procedure or surgery | laparoscopic surgery for right colon cancer |
Primary outcome
3-year disease-free survival rate
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
The time from randomization to first tumor recurrence/metastasis or death from any cause was defined as the time of last follow-up for patients lost to follow-up(Patients still alive at the end of the study, the end of follow-up).
2 secondary outcomes
30-day perioperative complications
Time frame: up to 1 month.
Overall survival
Time frame: 5-year
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 20 May 2024.
- 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.
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?
A study testing DaVinci si or xi system and laparoscopic radical resection in people with Colon Cancer and Robotic Surgery, run by Sir Run Run Shaw Hospital 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 7 inclusion and 11 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: opening soon, as of the sponsor's last update on 20 May 2024. 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 disease-free survival rate (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months). 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 20 May 2024.