RoboticNCT06454253
Short- and Long-term Outcomes of Robotic vs Laparoscopic Right Colon Cancer: a 10-year Single-center Retrospective Study
An observational study of Robotic and Laparoscopic, run by Taiyuan Li.
Trial summary
The goal of this observational study is to evaluate the short-term outcomes and long-term outcomes of robot-assisted right colon group for cancer compared to laparoscopic-assisted right colon group. This is a large sample study based on ten years of clinical data. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Robotic, Laparoscopic, Colon Cancer
- What is being tested?
- Da Vinci Robot Surgical System
- Type of treatment
- Medical device
- How many people
- 1,879 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2014to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The consecutive cases of robotic-assisted or laparoscopic-assisted right colectomy between December 2014 and March 2024. All cases derived from the First Affiliated Hospital of Nanchang University.
Who may be able to join
- The age is more than 18 years old and less than or equal to 85 years old
- No distant metastasis (including pelvic cavity, peritoneum, liver, lung, brain, bone, distant lymph node metastasis, etc.) is judged by ultrasound, CT, PET-CT, etc
- Preoperative colonoscopy showing that the tumor was located in the ileocecal region, ascending colon, hepatic flexure, or transverse colon with pathology showing malignancy
- signed informed consent. -
Who cannot join
- multiple primary colorectal cancer
- recurrent right colon cancer
- preoperative neoadjuvant chemotherapy
- emergency surgery for intestinal obstruction, bleeding or perforation
- incomplete data and missing follow-up data. -
About this study
Official title: the Ethics Committee of the First Affiliated Hospital of Nanchang University
The goal of this observational study is to evaluate the short-term outcomes and long-term outcomes of robot-assisted right colon group for cancer compared to laparoscopic-assisted right colon group. This is a large sample study based on ten years of clinical data. The main question it aims to answer is: What are the advantages of da Vinci robot right hemicolectomy compared to laparoscopic right hemicolectomy, and is there a difference in long-term efficacy between the two methods.
Read the detailed description
Colorectal cancer (CRC) is highly prevalent worldwide. In China, CRC ranks high among the population of men and women with cancer. The incidence and mortality rates of CRC are rising quickly in developing countries, and it is the fourth most deadly cancer in the world. In particular, the right colon cancer (RCC) is continuously growing in China, and the early symptoms of RCC are not typical. one of the most useful ways for RCC is surgical is a surgical operation. Along with the development of minimally invasive surgery, the use of laparoscopy for colon cancer is widely accepted and has become one symbolic surgical technology. Studies have demonstrated that laparoscopic colonic surgery is related to reduced pain after operation, shorter rehabilitation time, shorter length of hospital stay, reduced the time of ileus after surgery, and reduced surgical site infection.
Nevertheless, laparoscopic surgery also has its shortcoming, including a limited range of motion, slow learning and growth, and physiological tremor cannot be eliminated.The emergence of robots has broken the inherent disadvantage of laparoscopy. It has achieved similar or better results in previous studies. Based on these advantages, robotic surgery has received much attention from the surgeons. With the first robotic surgery in the field of colon cancer was reported in 2002, there are some studies proved the safety and feasibility by using robot,However, most studies with small sample sizes and with cases at a relatively early stage.
Therefore, the purpose of this study is to compare the short-term and long-term outcomes between RARC and LARC in the treatment of right colon cancer in our center.
- Conditions
- Robotic, Laparoscopic, Colon Cancer, Long-term Outcomes, Short-term Outcomes
- Being tested
- Da Vinci Robot Surgical System
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Da Vinci Robot Surgical SystemDevice
Also called Laparoscopic surgical system
Performing surgery on right colon cancer patients using the da Vinci robotic surgical system or laparoscopic surgical system
| Study group | Role | What they receive |
|---|---|---|
| robot-assisted right colon group | Robot assisted radical surgery for right colon cancer Receives: Device: Da Vinci Robot Surgical System | |
| laparoscopic-assisted right colon group | Laparoscopic assisted radical surgery for right colon cancer Receives: Device: Da Vinci Robot Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
months
Measured: 5 years after surgery
disease-free survival
months
Measured: 5 years after surgery
Secondary outcomes (8)
the rate of postoperative complications
rate
Measured: 1 months after surgery
operative time
minutes
Measured: Intraoperative
estimation of blood loss
milliliters
Measured: Intraoperative
number of retrieved lymph nodes
numbers
Measured: Intraoperative
days after postoperative hospital stay
days
Measured: 1 months after surgery
time to first exhaust
hours
Measured: 1 weeks after surgery
time to liquid diet
hours
Measured: 1 weeks after surgery
the rate of intracorporeal anastomosis
rate
Measured: 1 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 Dec 2014
- Primary completion31 Mar 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RoboticStudies 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
- 1,879 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiyuan Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Taiyuan Li, Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454253
- Sponsor's protocol ID
- IIT2023015
- Status last verified
- Jun 2024
- First submitted
- 29 May 2024
- Last updated
- 12 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Access to the database can be obtained from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Ethics Committee of the First Affiliated Hospital of Nanchang University
- ClinicalTrials.gov ID
- NCT06454253
- Acronym / sponsor ID
- IIT2023015
- Conditions
- Robotic, Laparoscopic, Colon Cancer, Long-term Outcomes, Short-term Outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,879 participants (actual)
- Lead sponsor
- Taiyuan LiUniversity, hospital or other
- Study start
- 1 Dec 2014 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 12 Jun 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.
The goal of this observational study is to evaluate the short-term outcomes and long-term outcomes of robot-assisted right colon group for cancer compared to laparoscopic-assisted right colon group. This is a large sample study based on ten years of clinical data. The main question it aims to answer is: What are the advantages of da Vinci robot right hemicolectomy compared to laparoscopic right hemicolectomy, and is there a difference in long-term efficacy between the two methods.
Detailed description
Colorectal cancer (CRC) is highly prevalent worldwide. In China, CRC ranks high among the population of men and women with cancer. The incidence and mortality rates of CRC are rising quickly in developing countries, and it is the fourth most deadly cancer in the world. In particular, the right colon cancer (RCC) is continuously growing in China, and the early symptoms of RCC are not typical. one of the most useful ways for RCC is surgical is a surgical operation. Along with the development of minimally invasive surgery, the use of laparoscopy for colon cancer is widely accepted and has become one symbolic surgical technology. Studies have demonstrated that laparoscopic colonic surgery is related to reduced pain after operation, shorter rehabilitation time, shorter length of hospital stay, reduced the time of ileus after surgery, and reduced surgical site infection.
Nevertheless, laparoscopic surgery also has its shortcoming, including a limited range of motion, slow learning and growth, and physiological tremor cannot be eliminated.The emergence of robots has broken the inherent disadvantage of laparoscopy. It has achieved similar or better results in previous studies. Based on these advantages, robotic surgery has received much attention from the surgeons. With the first robotic surgery in the field of colon cancer was reported in 2002, there are some studies proved the safety and feasibility by using robot,However, most studies with small sample sizes and with cases at a relatively early stage.
Therefore, the purpose of this study is to compare the short-term and long-term outcomes between RARC and LARC in the treatment of right colon cancer in our center.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| robot-assisted right colon group | – | Device: Da Vinci Robot Surgical SystemRobot assisted radical surgery for right colon cancer |
| laparoscopic-assisted right colon group | – | Device: Da Vinci Robot Surgical SystemLaparoscopic assisted radical surgery for right colon cancer |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The consecutive cases of robotic-assisted or laparoscopic-assisted right colectomy between December 2014 and March 2024. All cases derived from the First Affiliated Hospital of Nanchang University.
Key inclusion criteria (4 listed)
- The age is more than 18 years old and less than or equal to 85 years old
- No distant metastasis (including pelvic cavity, peritoneum, liver, lung, brain, bone, distant lymph node metastasis, etc.) is judged by ultrasound, CT, PET-CT, etc
- Preoperative colonoscopy showing that the tumor was located in the ileocecal region, ascending colon, hepatic flexure, or transverse colon with pathology showing malignancy
- signed informed consent. -
Key exclusion criteria (5 listed)
- multiple primary colorectal cancer
- recurrent right colon cancer
- preoperative neoadjuvant chemotherapy
- emergency surgery for intestinal obstruction, bleeding or perforation
- incomplete data and missing follow-up data. -
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 |
|---|---|---|
| Da Vinci Robot Surgical SystemAlso: Laparoscopic surgical systemPerforming surgery on right colon cancer patients using the da Vinci robotic surgical system or laparoscopic surgical system | Device | laparoscopic-assisted right colon group, robot-assisted right colon group |
Primary outcome
overall survival
Time frame: 5 years after surgery
months
disease-free survival
Time frame: 5 years after surgery
months
8 secondary outcomes
the rate of postoperative complications
Time frame: 1 months after surgery
operative time
Time frame: Intraoperative
estimation of blood loss
Time frame: Intraoperative
number of retrieved lymph nodes
Time frame: Intraoperative
days after postoperative hospital stay
Time frame: 1 months after surgery
time to first exhaust
Time frame: 1 weeks after surgery
time to liquid diet
Time frame: 1 weeks after surgery
the rate of intracorporeal anastomosis
Time frame: 1 months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2024.
- Individual participant dataSharing planned: Undecided. Access to the database can be obtained from the corresponding author on reasonable request.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Robotic and Laparoscopic, run by Taiyuan Li.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 12 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
overall survival (time frame: 5 years after surgery). The study lists 2 primary outcomes in all. 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 12 Jun 2024.