Colorectal Carcinoma (CRC)NCT07138859
The Intraoperative Technical Errors of Robotic vs. Laparoscopic Radical Right Hemiclectomy
A study testing Robot assisted radical right hemicolectomy (D3 lymph node dissection) and Laparoscopic assisted radical right hemicolectomy (D3 lymph node dissection) in people with Colorectal Carcinoma (CRC) and Right Hemicolectomy, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Carcinoma (CRC), Right Hemicolectomy
- What is being tested?
- Robot assisted radical right hemicolectomy (D3 lymph node dissection) and Laparoscopic assisted radical right hemicolectomy (D3 lymph node dissection)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 368 participants
- Where
- 1 siteChina
- Study dates
- Aug 2025to Dec 2030
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old<age<80 years old, regardless of gender;
- The primary lesion of the colon was diagnosed as colon adenocarcinoma (well differentiated adenocarcinoma, moderately differentiated adenocarcinoma, poorly differentiated adenocarcinoma, mucinous adenocarcinoma) through endoscopic biopsy tissue pathology;
- The preoperative clinical staging was cStage I-III (cT1-4a, N0/+, M0) (according to UICC/AJCC-8thTNM tumor staging);
- The primary lesions of the colon are located in the cecum, ascending colon, hepatic flexure of the colon, and right half of the transverse colon. It is expected that right-sided colectomy and D3 lymph node dissection can achieve R0 surgical results (excluding multiple primary cancers);
- Preoperative examination showed no distant metastasis, and the tumor did not directly invade adjacent organs;
- Preoperative ECOG physical status score ≤ 2;
- Preoperative ASA scores I-III;
- Patient informed consent.
Who cannot join
- History of colon surgery (excluding ESD/EMR for colon cancer);
- History of major abdominal surgery (excluding laparoscopic cholecystectomy and appendectomy);
- Preoperative body temperature ≥ 38 ℃ or complicated with infectious diseases requiring systematic treatment;
- Pregnant or lactating women;
- Suffering from severe mental illness;
- Multiple primary cancers;
Show all 12Show fewer
- History of other malignant diseases within 5 years;
- Any neoadjuvant therapy such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc. has been implemented;
- History of unstable angina or myocardial infarction within 6 months;
- Heart, lung, liver, kidney dysfunction or history of cerebral infarction;
- Simultaneous surgical treatment is required for other diseases;
- Colorectal cancer complications (bleeding, perforation, obstruction) require emergency surgery.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Affiliated Hospital of Qingdao University
Shandong, Province, 266071
About this study
Official title: Prospective, Multiceter, Randomized, Controlled Study on the Intraoperative Technical Errors of Robotic vs. Laparoscopic Radical Right Hemiclectomy (Superiority Design，ROBOGEON® 2501study)
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.
Read more
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<age<80 years old, regardless of gender; 2) The primary lesion of the colon was diagnosed as colon adenocarcinoma (well differentiated adenocarcinoma, moderately differentiated adenocarcinoma, poorly differentiated adenocarcinoma, mucinous adenocarcinoma) through endoscopic biopsy tissue pathology; 3) The preoperative clinical staging was cStage I-III (cT1-4a, N0/+, M0) (according to UICC/AJCC-8thTNM tumor staging); 4) The primary lesions of the colon are located in the cecum, ascending colon, hepatic flexure of the colon, and right half of the transverse colon. It is expected that right-sided colectomy and D3 lymph node dissection can achieve R0 surgical results (excluding multiple primary cancers); 5) Preoperative examination showed no distant metastasis, and the tumor did not directly invade adjacent organs; 6) Preoperative ECOG physical status score ≤ 2; 7) Preoperative ASA scores I-III; 8) Patient informed consent.
Exclusion criteria: 1) History of colon surgery (excluding ESD/EMR for colon cancer); 2) History of major abdominal surgery (excluding laparoscopic cholecystectomy and appendectomy); 3) Preoperative body temperature ≥ 38 ℃ or complicated with infectious diseases requiring systematic treatment; 4) Pregnant or lactating women; 5) Suffering from severe mental illness; 6) Multiple primary cancers; 7) History of other malignant diseases within 5 years; 8) Any neoadjuvant therapy such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc. has been implemented; 9) History of unstable angina or myocardial infarction within 6 months; 10) Heart, lung, liver, kidney dysfunction or history of cerebral infarction; 11) Simultaneous surgical treatment is required for other diseases; 12) Colorectal cancer complications (bleeding, perforation, obstruction) require emergency surgery.
Read the detailed description
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:
- Complete pneumoperitoneum - exposure of the surgical area.
- 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).
- 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.
- 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.
- 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.
- Conditions
- Colorectal Carcinoma (CRC), Right Hemicolectomy
- Being tested
- Robot assisted radical right hemicolectomy (D3 lymph node dissection), Laparoscopic assisted radical right hemicolectomy (D3 lymph node dissection)
- Keywords
- Colorectal Carcinoma (CRC), right hemicolectomy, Robotic surgery, Errors, Intraoperative bleeding, Dangerous areas, Clinical outcome
- Medical subject headings
- Colorectal Neoplasms, Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot assisted radical right hemicolectomy (D3 lymph node dissection)Device
RRH (Robotic Right Hemicolectomy) group: Experimental group: Performing robotic radical right hemicolectomy (D3 lymph node dissection)
Laparoscopic assisted radical right hemicolectomy (D3 lymph node dissection)Device
LRH (Laparoscopic Right Hemicolectomy) group: control group: underwent laparoscopic radical right hemicolectomy (D3 lymph node dissection)
| Study group | Role | What they receive |
|---|---|---|
| Robot right hemicolectomy group | Experimental | Perform robot assisted radical right hemicolectomy (D3 lymph node dissection) Receives: Device: Robot assisted radical right hemicolectomy (D3 lymph node dissection) |
| Laparoscopic right hemicolectomy group | Active comparator | Performing traditional laparoscopic radical right hemicolectomy (D3 lymph node dissection) Receives: Device: Laparoscopic assisted radical right hemicolectomy (D3 lymph node dissection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of technical errors during right hemicolectomy
Measured: Perioperative
Secondary outcomes (13)
Incidence of intraoperative complications
Measured: Perioperative
Postoperative hospitalization time
Measured: Perioperative
Incidence of complications within 30 days after surgery
Measured: Within 30 days after surgery
3-year disease-free survival rate DFS
Measured: Within 3 years after surgery
Surgical time
Measured: Perioperative
estimated blood loss
Measured: Perioperative
conversion rate to open surgery
Measured: Perioperative
Early postoperative recovery process (time of first exhaust and defecation)
Measured: Perioperative
Postoperative nutritional status, inflammation, and immune response
Measured: Perioperative
Total number of lymph nodes cleared, positive rate of lymph nodes
Measured: Perioperative
readmission rate within 30 days after surgery
Measured: Within 30 days after surgery
unplanned reoperation rate within 30 days after surgery
Measured: Within 30 days after surgery
3-year overall survival rate OS
Measured: Within 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (29)Papers the sponsor has linked to this study.
- Other trials for Colorectal Carcinoma (CRC)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 368 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhou Yanbing, The Affiliated Hospital of Qingdao University
- Investigators
- Yanbing Zhou, Principal investigator, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138859
- Sponsor's protocol ID
- ROBOGEON 2501 study
- Status last verified
- Aug 2025
- First submitted
- 17 Jul 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.).
Publications
Tejedor P, Francis N, Jayne D, Hohenberger W, Khan J; on behalf the CME Project Working Group. Consensus statements on complete mesocolic excision for right-sided colon cancer-technical steps and training implications. Surg Endosc. 2022 Aug;36(8):5595-5601. doi: 10.1007/s00464-021-08395-0. Epub 2022 Jul 5.
PubMed 35790593Lu J, Xing J, Zang L, Zhang C, Xu L, Zhang G, He Z, Sun Y, Feng Y, Du X, Hu S, Chi P, Huang Y, Wang Z, Zhong M, Wu A, Zhu A, Li F, Xu J, Kang L, Suo J, Deng H, Ye Y, Ding K, Xu T, Zhang Y, Zhang Z, Zheng M, Su X, Xiao Y; RELARC study group. Extent of Lymphadenectomy for Surgical Management of Right-Sided Colon Cancer: The Randomized Phase III RELARC Trial. J Clin Oncol. 2024 Nov 20;42(33):3957-3966. doi: 10.1200/JCO.24.00393. Epub 2024 Aug 27.
PubMed 39190853Ahadi M, Sokolova A, Brown I, Chou A, Gill AJ. The 2019 World Health Organization Classification of appendiceal, colorectal and anal canal tumours: an update and critical assessment. Pathology. 2021 Jun;53(4):454-461. doi: 10.1016/j.pathol.2020.10.010. Epub 2021 Jan 16.
PubMed 33461799Gorard J, Boal M, Swamynathan V, Ghamrawi W, Francis N. The application of objective clinical human reliability analysis (OCHRA) in the assessment of basic robotic surgical skills. Surg Endosc. 2024 Jan;38(1):116-128. doi: 10.1007/s00464-023-10510-2. Epub 2023 Nov 6.
PubMed 37932602Tang B, Hanna GB, Joice P, Cuschieri A. Identification and categorization of technical errors by Observational Clinical Human Reliability Assessment (OCHRA) during laparoscopic cholecystectomy. Arch Surg. 2004 Nov;139(11):1215-20. doi: 10.1001/archsurg.139.11.1215.
PubMed 15545569Foster JD, Miskovic D, Allison AS, Conti JA, Ockrim J, Cooper EJ, Hanna GB, Francis NK. Application of objective clinical human reliability analysis (OCHRA) in assessment of technical performance in laparoscopic rectal cancer surgery. Tech Coloproctol. 2016 Jun;20(6):361-367. doi: 10.1007/s10151-016-1444-4. Epub 2016 May 6.
PubMed 27154295Dyreborg J, Lipscomb HJ, Nielsen K, Torner M, Rasmussen K, Frydendall KB, Bay H, Gensby U, Bengtsen E, Guldenmund F, Kines P. Safety interventions for the prevention of accidents at work: A systematic review. Campbell Syst Rev. 2022 Jun 1;18(2):e1234. doi: 10.1002/cl2.1234. eCollection 2022 Jun.
PubMed 36911341Miskovic D, Ni M, Wyles SM, Parvaiz A, Hanna GB. Observational clinical human reliability analysis (OCHRA) for competency assessment in laparoscopic colorectal surgery at the specialist level. Surg Endosc. 2012 Mar;26(3):796-803. doi: 10.1007/s00464-011-1955-z. Epub 2011 Nov 1.
PubMed 22042584Jia Z, Cao S, Wang D, Tang C, Tan X, Liu S, Liu X, Li Z, Tian Y, Niu Z, Tang B, Zhou Y. Identification and Categorization of Technical Errors and Hazard Zones of Robotic Versus Laparoscopic Total Gastrectomy for Gastric Cancer: A Single-center Prospective Randomized Controlled Study. Ann Surg. 2025 Jul 1;282(1):37-45. doi: 10.1097/SLA.0000000000006585. Epub 2024 Nov 8.
PubMed 39513271Kitz J, Fokas E, Beissbarth T, Strobel P, Wittekind C, Hartmann A, Ruschoff J, Papadopoulos T, Rosler E, Ortloff-Kittredge P, Kania U, Schlitt H, Link KH, Bechstein W, Raab HR, Staib L, Germer CT, Liersch T, Sauer R, Rodel C, Ghadimi M, Hohenberger W; German Rectal Cancer Study Group. Association of Plane of Total Mesorectal Excision With Prognosis of Rectal Cancer: Secondary Analysis of the CAO/ARO/AIO-04 Phase 3 Randomized Clinical Trial. JAMA Surg. 2018 Aug 1;153(8):e181607. doi: 10.1001/jamasurg.2018.1607. Epub 2018 Aug 15.
PubMed 29874375Curtis NJ, Dennison G, Brown CSB, Hewett PJ, Hanna GB, Stevenson ARL, Francis NK. Clinical Evaluation of Intraoperative Near Misses in Laparoscopic Rectal Cancer Surgery. Ann Surg. 2021 Apr 1;273(4):778-784. doi: 10.1097/SLA.0000000000003452.
PubMed 31274657Zhang Y, Feng H, Wang S, Gu Y, Shi Y, Song Z, Deng Y, Ji X, Cheng X, Zhang T, Zhao R. Short- and long-term outcomes of robotic- versus laparoscopic-assisted right hemicolectomy: A propensity score-matched retrospective cohort study. Int J Surg. 2022 Sep;105:106855. doi: 10.1016/j.ijsu.2022.106855. Epub 2022 Aug 24.
PubMed 36030038Clarke EM, Rahme J, Larach T, Rajkomar A, Jain A, Hiscock R, Warrier S, Smart P. Robotic versus laparoscopic right hemicolectomy: a retrospective cohort study of the Binational Colorectal Cancer Database. J Robot Surg. 2022 Aug;16(4):927-933. doi: 10.1007/s11701-021-01319-z. Epub 2021 Oct 28.
PubMed 34709537de'Angelis N, Schena CA, Espin-Basany E, Piccoli M, Alfieri S, Aisoni F, Coccolini F, Frontali A, Kraft M, Lakkis Z, Le Roy B, Luzzi AP, Milone M, Pattacini GC, Pellino G, Petri R, Piozzi GN, Quero G, Ris F, Winter DC, Khan J; MERCY Study Collaborating Group Members. Robotic versus laparoscopic right colectomy for nonmetastatic pT4 colon cancer: A European multicentre propensity score-matched analysis. Colorectal Dis. 2024 Aug;26(8):1569-1583. doi: 10.1111/codi.17089. Epub 2024 Jul 8.
PubMed 38978153Formisano G, Misitano P, Giuliani G, Calamati G, Salvischiani L, Bianchi PP. Laparoscopic versus robotic right colectomy: technique and outcomes. Updates Surg. 2016 Mar;68(1):63-9. doi: 10.1007/s13304-016-0353-4. Epub 2016 Mar 18.
PubMed 26992927
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multiceter, Randomized, Controlled Study on the Intraoperative Technical Errors of Robotic vs. Laparoscopic Radical Right Hemiclectomy (Superiority Design，ROBOGEON® 2501study)
- ClinicalTrials.gov ID
- NCT07138859
- Acronym / sponsor ID
- ROBOGEON 2501 study
- Conditions
- Colorectal Carcinoma (CRC), Right Hemicolectomy
- Keywords
- Colorectal Carcinoma (CRC), right hemicolectomy, Robotic surgery, Errors, Intraoperative bleeding, Dangerous areas, Clinical outcome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 368 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 24 Aug 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.
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<age<80 years old, regardless of gender; 2) The primary lesion of the colon was diagnosed as colon adenocarcinoma (well differentiated adenocarcinoma, moderately differentiated adenocarcinoma, poorly differentiated adenocarcinoma, mucinous adenocarcinoma) through endoscopic biopsy tissue pathology; 3) The preoperative clinical staging was cStage I-III (cT1-4a, N0/+, M0) (according to UICC/AJCC-8thTNM tumor staging); 4) The primary lesions of the colon are located in the cecum, ascending colon, hepatic flexure of the colon, and right half of the transverse colon. It is expected that right-sided colectomy and D3 lymph node dissection can achieve R0 surgical results (excluding multiple primary cancers); 5) Preoperative examination showed no distant metastasis, and the tumor did not directly invade adjacent organs; 6) Preoperative ECOG physical status score ≤ 2; 7) Preoperative ASA scores I-III; 8) Patient informed consent.
Exclusion criteria: 1) History of colon surgery (excluding ESD/EMR for colon cancer); 2) History of major abdominal surgery (excluding laparoscopic cholecystectomy and appendectomy); 3) Preoperative body temperature ≥ 38 ℃ or complicated with infectious diseases requiring systematic treatment; 4) Pregnant or lactating women; 5) Suffering from severe mental illness; 6) Multiple primary cancers; 7) History of other malignant diseases within 5 years; 8) Any neoadjuvant therapy such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc. has been implemented; 9) History of unstable angina or myocardial infarction within 6 months; 10) Heart, lung, liver, kidney dysfunction or history of cerebral infarction; 11) Simultaneous surgical treatment is required for other diseases; 12) Colorectal cancer complications (bleeding, perforation, obstruction) require emergency surgery.
Detailed description
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:
- Complete pneumoperitoneum - exposure of the surgical area.
- 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).
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot right hemicolectomy group | Experimental | Device: Robot assisted radical right hemicolectomy (D3 lymph node dissection)Perform robot assisted radical right hemicolectomy (D3 lymph node dissection) |
| Laparoscopic right hemicolectomy group | Active comparator | Device: Laparoscopic assisted radical right hemicolectomy (D3 lymph node dissection)Performing traditional laparoscopic radical right hemicolectomy (D3 lymph node dissection) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years old<age<80 years old, regardless of gender;
- The primary lesion of the colon was diagnosed as colon adenocarcinoma (well differentiated adenocarcinoma, moderately differentiated adenocarcinoma, poorly differentiated adenocarcinoma, mucinous adenocarcinoma) through endoscopic biopsy tissue pathology;
- The preoperative clinical staging was cStage I-III (cT1-4a, N0/+, M0) (according to UICC/AJCC-8thTNM tumor staging);
- The primary lesions of the colon are located in the cecum, ascending colon, hepatic flexure of the colon, and right half of the transverse colon. It is expected that right-sided colectomy and D3 lymph node dissection can achieve R0 surgical results (excluding multiple primary cancers);
- Preoperative examination showed no distant metastasis, and the tumor did not directly invade adjacent organs;
Key exclusion criteria (12 listed)
- History of colon surgery (excluding ESD/EMR for colon cancer);
- History of major abdominal surgery (excluding laparoscopic cholecystectomy and appendectomy);
- Preoperative body temperature ≥ 38 ℃ or complicated with infectious diseases requiring systematic treatment;
- Pregnant or lactating women;
- Suffering from severe mental illness;
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 |
|---|---|---|
| Robot assisted radical right hemicolectomy (D3 lymph node dissection)RRH (Robotic Right Hemicolectomy) group: Experimental group: Performing robotic radical right hemicolectomy (D3 lymph node dissection) | Device | Robot right hemicolectomy group |
| Laparoscopic assisted radical right hemicolectomy (D3 lymph node dissection)LRH (Laparoscopic Right Hemicolectomy) group: control group: underwent laparoscopic radical right hemicolectomy (D3 lymph node dissection) | Device | Laparoscopic right hemicolectomy group |
Primary outcome
Total number of technical errors during right hemicolectomy
Time frame: Perioperative
13 secondary outcomes
Incidence of intraoperative complications
Time frame: Perioperative
Postoperative hospitalization time
Time frame: Perioperative
Incidence of complications within 30 days after surgery
Time frame: Within 30 days after surgery
3-year disease-free survival rate DFS
Time frame: Within 3 years after surgery
Surgical time
Time frame: Perioperative
estimated blood loss
Time frame: Perioperative
conversion rate to open surgery
Time frame: Perioperative
Early postoperative recovery process (time of first exhaust and defecation)
Time frame: Perioperative
Postoperative nutritional status, inflammation, and immune response
Time frame: Perioperative
Total number of lymph nodes cleared, positive rate of lymph nodes
Time frame: Perioperative
readmission rate within 30 days after surgery
Time frame: Within 30 days after surgery
unplanned reoperation rate within 30 days after surgery
Time frame: Within 30 days after surgery
3-year overall survival rate OS
Time frame: Within 3 years after surgery
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 24 Aug 2025.
- Results publication: PubMed 35790593Tejedor P, Francis N, Jayne D, Hohenberger W, Khan J; on behalf the CME Project Working Group. Consensus statements on complete mesocolic excision for right-sided colon cancer-technical steps and training implications. Surg Endosc. 2022 Aug;36(8):5595-5601. doi: 10.1007/s00464-021-08395-0. Epub 2022 Jul 5.
- Results publication: PubMed 39190853Lu J, Xing J, Zang L, Zhang C, Xu L, Zhang G, He Z, Sun Y, Feng Y, Du X, Hu S, Chi P, Huang Y, Wang Z, Zhong M, Wu A, Zhu A, Li F, Xu J, Kang L, Suo J, Deng H, Ye Y, Ding K, Xu T, Zhang Y, Zhang Z, Zheng M, Su X, Xiao Y; RELARC study group. Extent of Lymphadenectomy for Surgical Management of Right-Sided Colon Cancer: The Randomized Phase III RELARC Trial. J Clin Oncol. 2024 Nov 20;42(33):3957-3966. doi: 10.1200/JCO.24.00393. Epub 2024 Aug 27.
- Results publication: PubMed 33461799Ahadi M, Sokolova A, Brown I, Chou A, Gill AJ. The 2019 World Health Organization Classification of appendiceal, colorectal and anal canal tumours: an update and critical assessment. Pathology. 2021 Jun;53(4):454-461. doi: 10.1016/j.pathol.2020.10.010. Epub 2021 Jan 16.
- Results publication: PubMed 37932602Gorard J, Boal M, Swamynathan V, Ghamrawi W, Francis N. The application of objective clinical human reliability analysis (OCHRA) in the assessment of basic robotic surgical skills. Surg Endosc. 2024 Jan;38(1):116-128. doi: 10.1007/s00464-023-10510-2. Epub 2023 Nov 6.
- Results publication: PubMed 15545569Tang B, Hanna GB, Joice P, Cuschieri A. Identification and categorization of technical errors by Observational Clinical Human Reliability Assessment (OCHRA) during laparoscopic cholecystectomy. Arch Surg. 2004 Nov;139(11):1215-20. doi: 10.1001/archsurg.139.11.1215.
- Results publication: PubMed 27154295Foster JD, Miskovic D, Allison AS, Conti JA, Ockrim J, Cooper EJ, Hanna GB, Francis NK. Application of objective clinical human reliability analysis (OCHRA) in assessment of technical performance in laparoscopic rectal cancer surgery. Tech Coloproctol. 2016 Jun;20(6):361-367. doi: 10.1007/s10151-016-1444-4. Epub 2016 May 6.
- Results publication: PubMed 36911341Dyreborg J, Lipscomb HJ, Nielsen K, Torner M, Rasmussen K, Frydendall KB, Bay H, Gensby U, Bengtsen E, Guldenmund F, Kines P. Safety interventions for the prevention of accidents at work: A systematic review. Campbell Syst Rev. 2022 Jun 1;18(2):e1234. doi: 10.1002/cl2.1234. eCollection 2022 Jun.
- Results publication: PubMed 22042584Miskovic D, Ni M, Wyles SM, Parvaiz A, Hanna GB. Observational clinical human reliability analysis (OCHRA) for competency assessment in laparoscopic colorectal surgery at the specialist level. Surg Endosc. 2012 Mar;26(3):796-803. doi: 10.1007/s00464-011-1955-z. Epub 2011 Nov 1.
- Results publication: PubMed 39513271Jia Z, Cao S, Wang D, Tang C, Tan X, Liu S, Liu X, Li Z, Tian Y, Niu Z, Tang B, Zhou Y. Identification and Categorization of Technical Errors and Hazard Zones of Robotic Versus Laparoscopic Total Gastrectomy for Gastric Cancer: A Single-center Prospective Randomized Controlled Study. Ann Surg. 2025 Jul 1;282(1):37-45. doi: 10.1097/SLA.0000000000006585. Epub 2024 Nov 8.
- Results publication: PubMed 29874375Kitz J, Fokas E, Beissbarth T, Strobel P, Wittekind C, Hartmann A, Ruschoff J, Papadopoulos T, Rosler E, Ortloff-Kittredge P, Kania U, Schlitt H, Link KH, Bechstein W, Raab HR, Staib L, Germer CT, Liersch T, Sauer R, Rodel C, Ghadimi M, Hohenberger W; German Rectal Cancer Study Group. Association of Plane of Total Mesorectal Excision With Prognosis of Rectal Cancer: Secondary Analysis of the CAO/ARO/AIO-04 Phase 3 Randomized Clinical Trial. JAMA Surg. 2018 Aug 1;153(8):e181607. doi: 10.1001/jamasurg.2018.1607. Epub 2018 Aug 15.
- Results publication: PubMed 31274657Curtis NJ, Dennison G, Brown CSB, Hewett PJ, Hanna GB, Stevenson ARL, Francis NK. Clinical Evaluation of Intraoperative Near Misses in Laparoscopic Rectal Cancer Surgery. Ann Surg. 2021 Apr 1;273(4):778-784. doi: 10.1097/SLA.0000000000003452.
- Results publication: PubMed 36030038Zhang Y, Feng H, Wang S, Gu Y, Shi Y, Song Z, Deng Y, Ji X, Cheng X, Zhang T, Zhao R. Short- and long-term outcomes of robotic- versus laparoscopic-assisted right hemicolectomy: A propensity score-matched retrospective cohort study. Int J Surg. 2022 Sep;105:106855. doi: 10.1016/j.ijsu.2022.106855. Epub 2022 Aug 24.
- Individual participant dataSharing planned: Yes. 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.).
Related trials for Colorectal Carcinoma (CRC)
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Not yet recruitingPhase 2
Phase II Clinical Study of RC148 (ABBV-1480) in Combination With Telisotuzumab Adizutecan (With or Without Chemotherapy) for Unresectable Colorectal Cancer
Patients With Unresectable Colorectal Cancer Requiring First-Line or Second-Line Therapy
RecruitingPhase 1
A Study to Learn About Study Medicine ALTA3263 in Adults With Advanced Solid Tumors With KRAS Mutations
Cancer, PDAC - Pancreatic Ductal Adenocarcinoma
RecruitingObservational study
Biopsy-Resection Agreement of Peritoneal Histopathological Growth Patterns in Colorectal Peritoneal Metastases: A Prospective Observational Pilot Study
Peritoneal (Metastatic) Cancer, Colorectal Cancer
RecruitingObservational study
Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
Solid Tumor, Adult, Colorectal Cancer
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.
Yanbing Zhou principal investigator
The Affiliated Hospital of Qingdao University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robot assisted radical right hemicolectomy (D3 lymph node dissection) and Laparoscopic assisted radical right hemicolectomy (D3 lymph node dissection) in people with Colorectal Carcinoma (CRC) and Right Hemicolectomy, run by The Affiliated Hospital of Qingdao University 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 8 inclusion and 12 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 24 Aug 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?
Contact Kun Wang (+86 15621138120, wangkun180930@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of technical errors during right hemicolectomy (time frame: Perioperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07138859, which also lists 29 linked publications.
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 24 Aug 2025.