Experimental design: This study is a multicenter, prospective, randomized, controlled phase III clinical trial that identifies, classifies, defines, and quantitatively analyzes technical errors between robotic and laparoscopic radical right hemicolectomy (D3 lymph node dissection), identifies surgical risk areas, compares intraoperative performance, and patient short-term and long-term clinical outcomes.

This experimental design was based on a 1:1 effective target case ratio between the experimental group and the control group for enrollment. The experimental group underwent robotic radical right hemicolectomy (D3 lymph node dissection), while the control group underwent laparoscopic radical right hemicolectomy (D3 lymph node dissection). The unedited surgical videos of patients were analyzed, and relevant indicators and adverse events were recorded. Patients were followed up in the outpatient department after discharge until 3 years after surgery or until death or recurrence.

Sample size calculation: In this study, the calculation of sample size was based on pre experiments and hypotheses, and a goodness test was conducted by selecting the means of two independent samples. Referring to the results of the pilot study, based on a 1:1 random (random number table method) ratio, assuming a significance level of unilateral α=0.025, a test power of 1- β=80%, and a superiority margin of 20% in reducing the number of errors, and considering the maximum dropout rate of 0.1 in this clinical study, the total sample size for this study was determined to be 368 patients (184 in the RRC group and 184 in the LRC group).

Primary endpoint: incidence of technical errors during right hemicolectomy. Secondary endpoint: incidence of intraoperative complications; The incidence of complications within 30 days after surgery; Total surgical time, robot/laparoscope time; Estimate the amount of blood loss; Conversion to open surgery rate; Postoperative hospitalization time; Total number of lymph nodes cleared and positive rate of lymph nodes; Early postoperative recovery process (time of first defecation and defecation); 30 day readmission rate and unplanned reoperation rate after surgery; Postoperative nutritional status, inflammation, and immune response; 3-year disease-free survival rate DFS; 3-year overall survival rate (OS).

Inclusion criteria: 1) 18 years old\

Right hemicolectomy and lymph node dissection scope: According to the Japanese Society for Colorectal Cancer Research (JSCCR) colon cancer treatment guidelines and the Chinese Society of Clinical Oncology (CSCO) colon cancer diagnosis and treatment guidelines, total mesorectal resection and D3 lymph node dissection are performed.

There are no requirements for digestive reconstruction methods, energy equipment, vascular ligation methods, gastrointestinal cutting and closure, digestive reconstruction instruments, or placement of abdominal drainage tubes.

Surgical task division

This study only records and analyzes the in vivo operation part (from Trocar insertion to CME release and vascular dissection), and does not require intestinal transverse and anastomosis methods, nor does it include statistical analysis. There are no specific requirements for the sequence of dissection and surgical operations. The main tasks can be divided into 5 parts:

1. Complete pneumoperitoneum - exposure of the surgical area.

2. Free posterior colon space (RRCS) and right colon:

   Find and open the Toldt gap, extend the gap until the dissociation of the right colon is completed. All operations in the RRCS area should belong to this recording section (right boundary: right colonic sulcus; left boundary: duodenal box; anterior: transverse mesentery; posterior: pre renal fascia).

3. Expose and ligate colon blood vessels or search for mesenteric blood vessels and open the vascular sheath, and clean lymph nodes:

   Expose and dissect the anterior part where the root of the colonic blood vessels merges into the SMV, ligate the colonic blood vessels, and perform root ligation on the right or main branch of the colonic blood vessels according to the tumor location. Expose the descending part of the duodenum and the head of the pancreas, dissect the SMV, and use the SMV as the inner boundary for lymph node dissection.

4. Open the gastrocolic ligament and search for the mesentery space:

   Open the root of the transverse colon mesentery and the gastrocolic ligament to fully free the transverse colon. During the process of drifting to the right, it is necessary to fully distinguish the gap between the transverse colon mesentery and the gastroduodenal mesentery.

5. Free transverse colon posterior space (TRCS) and anatomical Henle trunk:

Enter and maintain the TRCS until the branch dissection of the Henle trunk is completed. All operations involving the TRCS region (lateral boundary: descending segment of duodenum; medial boundary: superior mesenteric vein; head side: root of transverse mesentery; tail side boundary: horizontal part of duodenum; ventral boundary: dorsal side of transverse mesentery; dorsal side: anterior pancreatic fascia) and Henle trunk dissection should be included in this recording section.

Intraoperative bleeding grading Level 1: There is bleeding, but it does not affect the surgical operation and does not require any treatment; Level 2: Wound bleeding, unnamed vessel bleeding, clear surgical field of view, electrocoagulation, ultrasonic knife or compression hemostasis can all control bleeding without stopping the surgery; Grade III: Small vein bleeding, tear of liver, spleen, and pancreatic capsule, with no impact on hemodynamics. The surgical field of view is blurred, which affects the surgery, so it is necessary to stop the surgery to stop bleeding; Level 4: Bleeding from larger blood vessels and their branches, as well as the main blood vessels supplying the gastrointestinal tract, with hemodynamic fluctuations and ineffective compression hemostasis. Surgical hemostasis needs to be stopped, which can be controlled under the microscope and does not require conversion to open surgery; Grade 5: Bleeding from major blood vessels and their branches, as well as the main blood vessels supplying the gastrointestinal tract, with unstable hemodynamics, requiring a small amount of blood transfusion, uncontrollable under the microscope, and requiring conversion to open surgery for hemostasis. The patient's prognosis is good; Grade 6: Large abdominal blood vessels cause massive bleeding and have significant hemodynamic effects. A large amount of blood transfusion and vascular repair are required, which may lead to organ ischemia. The patient has a poor prognosis and may die.

Review of video footage. All unedited surgical videos are uploaded to the data platform of this study and handed over to two blind review expert reviewers with over 1000 hours of laparoscopic surgical video review experience in the surgical simulation laboratory of the Cuschieri Surgical Clinical Skills Training Center at the University of Dundee in the UK for identification, re coding, and analysis. Prior to the research, the reviewer completed 8 months of human factors engineering training under the guidance of clinical scientists at the University of Dundee's OC-HRA specialist (B.J.T.), which is a necessary prerequisite for proficient use of OC-HRA. Afterwards, reviewers and OC-HRA expert scientists independently analyzed ten videos of RRC and LRC. Ensure high inter rater reliability between the two reviewers. To ensure the accuracy of OC-HRA assessment video recordings, a research committee consisting of OC-HRA experts and experienced consultant surgeons conducted continuous inspections and supervision.

Inclusion Criteria:

1. 18 years old\

The specific items of IPD planned for sharing are as follows:

Demographic information: gender, age (years). Baseline characteristics: height, weight BMI、 Comorbidities (listed by ICD-10 code).

Primary endpoint indicator:

Number of intraoperative errors Secondary endpoint indicators;

Intervention information:

• Randomized grouping (experimental group/control group) Unshared data: directly identifiable personal information (name, address, phone number, complete date of birth, case number, original image files, etc.).

IPD First Sharing Start Date:

The main research results are expected to be published in a peer-reviewed journal on March 1, 2028.

End Date for IPD Sharing:

The results will remain open for 5 years after publication, and sharing will be closed on March 1, 2033.

Who: Qualified researchers with a scientifically valid proposal and documented approval from their local institutional review board (IRB) or ethics committee. Access is open to academic, non-profit, and regulatory entities; commercial organizations must provide a clear scientific rationale and sign the same data-use agreement (DUA).

What:A fully de-identified dataset containing all efficacy, safety, and demographic variables specified in the protocol. Accompanying documents: protocol, statistical analysis plan (SAP), informed-consent form, data dictionary, blank and annotated case-report forms, and variable-coding manuals.

How: Submit a brief research proposal plus IRB approval letter to the Data Sharing Committee via the secure portal. Data are downloaded as encrypted CSV/SAS transport files via a secure SFTP server; a remote virtual data enclave is also available for sensitive analyses. Data use is restricted to the approved project; any publication must cite the original trial.

Video reviewers: 2 blind reviewers with at least 1000 hours of experience in reviewing surgical videos; The inter rater reliability between the two reviewers is over 85%; Complete human factors engineering training; A research committee composed of OC-HRA experts and consultant surgeons with OC-HRA experience conducted continuous inspections and supervision.