Robotic Surgical ProceduresNCT07029464
Comparison of Short- and Long-term Outcomes Between Robotic and Laparoscopic Hemicolectomy of Right Colon Cancer : A Multicenter Propensity Score Matching Analysis
An observational study of Robotic Surgical Procedures and Right Colon Tumors, run by The First Affiliated Hospital of Nanchang University.
Trial summary
This is a retrospective, multicenter cohort study to compare short- and long-term outcomes between robotic and laparoscopic hemicolectomy of right colon cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Robotic Surgical Procedures, Right Colon Tumors, Cancer
- How many people
- 4,000 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to May 2027
- 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 procedures were performed by 16 surgeons from 16 participating centers. Both primary surgeons and assistants completed standardized training in robotic and laparoscopic surgical techniques and obtained certification. Each center performs over 100 robotic- or laparoscopic-assisted radical right hemicolectomies annually. Primary surgeons had performed at least 50 cases of both robotic and laparoscopic-assisted radical right hemicolectomy.
Who may be able to join
- 1.Underwent radical right hemicolectomy by Da Vinci robotic or laparoscopic surgery 2.Postoperative pathology confirmed right colon adenocarcinoma (pT2-T4aNxM0; including cecal adenocarcinoma, ascending colon adenocarcinoma, hepatic flexure colon adenocarcinoma, and proximal transverse colon adenocarcinoma) 3.Complete clinical data and pathological results available
Who cannot join
- 1.Received neoadjuvant therapy prior to surgery 2.History of other malignancies in the past 5 years (except cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin) 3.Distant metastases (e.g., liver, lung) or extensive abdominal/pelvic metastases confirmed by contrast-enhanced CT, PET-CT, or intraoperative exploration 4.Comorbid neurological/psychiatric disorders impairing ability to express informed consent 5.Poor systemic condition with contraindications to general anesthesia 6.Severe obesity (BMI >35 kg/m²) 7.Severe widespread abdominal adhesions precluding safe pneumoperitoneum establishment 8.Emergency surgery due to tumor perforation or obstruction 9.Refusal to provide informed consent
About this study
This is a retrospective, multicenter cohort study to compare short- and long-term outcomes between robotic and laparoscopic hemicolectomy of right colon cancer.
- Keywords
- right colon cancer, robotic surgery
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| R Group | robotic surgery | |
| L Group | Laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year overall survival (OS) rate and 3-year disease-free survival (DFS) rate
Measured: （OS）From post-operation until death or the 3-year study endpoint （DFS）From post-operation to tumor recurrence or the 3-year study endpoint
Secondary outcomes (10)
Operative time
Measured: Periprocedural
Intraoperative blood loss
Measured: Periprocedural
Time to first flatus/bowel movement
Measured: Periprocedural
Time to liquid diet initiation
Measured: Periprocedural
Time to ambulation
Measured: Periprocedural
Postoperative hospital stay duration
Measured: Up to 30 days
Postoperative complications
Surgery-related adverse events within 30 days, graded via the Clavien-Dindo classification system
Measured: From end of surgery to 30 days postoperatively
Postoperative white blood cell (WBC) count
Measured on postoperative days 1, 3, and 5
Measured: On postoperative days 1, 3, and 5
Postoperative C-reactive protein (CRP) level
Measured on postoperative days 1, 3, and 5
Measured: On postoperative days 1, 3, and 5
Pain score
Assessed using the Visual Analog Scale (VAS) on postoperative days 1, 3, and 5
Measured: On postoperative days 1, 3, and 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Robotic Surgical ProceduresStudies 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
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Nanchang University
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Fudan University, The Second Affiliated Hospital of Harbin Medical University, Three Gorges Hospital of Chongqing University, The Affiliated Hospital of Qingdao University, The First Affiliated Hospital of Zhengzhou University, Tianjin Third Central Hospital, Shandong University Second Hospital, Nanfang Hospital, Southern Medical University, Huadong Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, Second Xiangya Hospital of Central South University, Jiangxi Provincial People's Hopital, Pingxiang People 's Hospital, Ganzhou City People's Hospital
- Responsible party
- Principal investigator, Taiyuan Li, The First Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029464
- Sponsor's protocol ID
- IITS2025462
- Status last verified
- Jun 2025
- First submitted
- 26 May 2025
- Last updated
- 19 Jun 2025
- 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 19 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Short- and Long-term Outcomes Between Robotic and Laparoscopic Hemicolectomy of Right Colon Cancer : A Multicenter Propensity Score Matching Analysis
- ClinicalTrials.gov ID
- NCT07029464
- Acronym / sponsor ID
- IITS2025462
- Keywords
- right colon cancer, robotic surgery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Fudan University, The Second Affiliated Hospital of Harbin Medical University, Three Gorges Hospital of Chongqing University, The Affiliated Hospital of Qingdao University, The First Affiliated Hospital of Zhengzhou University, Tianjin Third Central Hospital, Shandong University Second Hospital, Nanfang Hospital, Southern Medical University, Huadong Hospital, Second Affiliated Hospital, Zhejiang University, School of Medicine, Second Xiangya Hospital of Central South University, Jiangxi Provincial People's Hopital, Pingxiang People 's Hospital, Ganzhou City People's Hospital
- Study start
- Jun 2025 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 19 Jun 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 is a retrospective, multicenter cohort study to compare short- and long-term outcomes between robotic and laparoscopic hemicolectomy of right colon cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| R Group | – | –robotic surgery |
| L Group | – | –Laparoscopic surgery |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The procedures were performed by 16 surgeons from 16 participating centers. Both primary surgeons and assistants completed standardized training in robotic and laparoscopic surgical techniques and obtained certification. Each center performs over 100 robotic- or laparoscopic-assisted radical right hemicolectomies annually. Primary surgeons had performed at least 50 cases of both robotic and laparoscopic-assisted radical right hemicolectomy.
Key inclusion criteria (1 listed)
- 1.Underwent radical right hemicolectomy by Da Vinci robotic or laparoscopic surgery 2.Postoperative pathology confirmed right colon adenocarcinoma (pT2-T4aNxM0; including cecal adenocarcinoma, ascending colon adenocarcinoma, hepatic flexure colon adenocarcinoma, and proximal transverse colon adenocarcinoma) 3.Complete clinical data and pathological results available
Key exclusion criteria (1 listed)
- 1.Received neoadjuvant therapy prior to surgery 2.History of other malignancies in the past 5 years (except cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin) 3.Distant metastases (e.g., liver, lung) or extensive abdominal/pelvic metastases confirmed by contrast-enhanced CT, PET-CT, or intraoperative exploration 4.Comorbid neurological/psychiatric disorders impairing ability to express informed consent 5.Poor systemic condition with contraindications to general anesthesia 6.Severe obesity (BMI >35 kg/m²) 7.Severe widespread abdominal adhesions precluding safe pneumoperitoneum establishment 8.Emergency surgery due to tumor perforation or obstruction 9.Refusal to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
3-year overall survival (OS) rate and 3-year disease-free survival (DFS) rate
Time frame: （OS）From post-operation until death or the 3-year study endpoint （DFS）From post-operation to tumor recurrence or the 3-year study endpoint
10 secondary outcomes
Operative time
Time frame: Periprocedural
Intraoperative blood loss
Time frame: Periprocedural
Time to first flatus/bowel movement
Time frame: Periprocedural
Time to liquid diet initiation
Time frame: Periprocedural
Time to ambulation
Time frame: Periprocedural
Postoperative hospital stay duration
Time frame: Up to 30 days
Postoperative complications
Time frame: From end of surgery to 30 days postoperatively
Postoperative white blood cell (WBC) count
Time frame: On postoperative days 1, 3, and 5
Postoperative C-reactive protein (CRP) level
Time frame: On postoperative days 1, 3, and 5
Pain score
Time frame: On postoperative days 1, 3, and 5
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 19 Jun 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.
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 Surgical Procedures and Right Colon Tumors, run by The First Affiliated Hospital of Nanchang University.
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 1 inclusion and 1 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 19 Jun 2025. 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?
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 overall survival (OS) rate and 3-year disease-free survival (DFS) rate (time frame: （OS）From post-operation until death or the 3-year study endpoint （DFS）From post-operation to tumor recurrence or the 3-year study endpoint). 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 19 Jun 2025.