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

NCT07138859 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: ROBOGEON 2501 study
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 1

Brief 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, 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.

Conditions

Colorectal Carcinoma (CRC); Right Hemicolectomy

Keywords

Colorectal Carcinoma (CRC); right hemicolectomy; Robotic surgery; Errors; Intraoperative bleeding; Dangerous areas; Clinical outcome

Outcome Measures

Primary Outcomes (1)

• Total number of technical errors during right hemicolectomy

  Perioperative

Secondary Outcomes (13)

• Incidence of intraoperative complications

  Perioperative

• Postoperative hospitalization time

  Perioperative

• Incidence of complications within 30 days after surgery

  Within 30 days after surgery

• 3-year disease-free survival rate DFS

  Within 3 years after surgery

• Surgical time

  Perioperative

Study Arms (2)

Robot right hemicolectomy group

EXPERIMENTAL

Perform robot assisted radical right hemicolectomy (D3 lymph node dissection)

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)

Device: Laparoscopic assisted radical right hemicolectomy (D3 lymph node dissection)

Interventions

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)

Robot right hemicolectomy group

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)

Laparoscopic right hemicolectomy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

The Affiliated Hospital of Qingdao University

Shandong, Province, 266071, China

Location

Related Publications (29)

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MeSH Terms

Conditions

Colorectal Neoplasms; Blood Loss, Surgical

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Intraoperative Complications

Study Officials

• Yanbing Zhou

  The Affiliated Hospital of Qingdao University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kun Wang

CONTACT

+86 15621138120; wangkun180930@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: August 24, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2030
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 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.
• Access Criteria: 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.

Locations

CN (1)