Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07138859

The Intraoperative Technical Errors of Robotic vs. Laparoscopic Radical Right Hemiclectomy

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;
  • 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.

Treatment and study plan

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)

Primary outcomes

  1. Total number of technical errors during right hemicolectomy

    Time frame: Perioperative

Secondary outcomes

  1. Incidence of intraoperative complications

    Time frame: Perioperative

  2. Postoperative hospitalization time

    Time frame: Perioperative

  3. Incidence of complications within 30 days after surgery

    Time frame: Within 30 days after surgery

  4. 3-year disease-free survival rate DFS

    Time frame: Within 3 years after surgery

  5. Surgical time

    Time frame: Perioperative

  6. estimated blood loss

    Time frame: Perioperative

  7. conversion rate to open surgery

    Time frame: Perioperative

  8. Early postoperative recovery process (time of first exhaust and defecation)

    Time frame: Perioperative

  9. Postoperative nutritional status, inflammation, and immune response

    Time frame: Perioperative

  10. Total number of lymph nodes cleared, positive rate of lymph nodes

    Time frame: Perioperative

  11. readmission rate within 30 days after surgery

    Time frame: Within 30 days after surgery

  12. unplanned reoperation rate within 30 days after surgery

    Time frame: Within 30 days after surgery

  13. 3-year overall survival rate OS

    Time frame: Within 3 years after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Registry information

Official study title

Prospective, Multiceter, Randomized, Controlled Study on the Intraoperative Technical Errors of Robotic vs. Laparoscopic Radical Right Hemiclectomy (Superiority Design,ROBOGEON® 2501study)

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Aug 24, 2025
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.