Status:
NOT_YET_RECRUITING
The Intraoperative Technical Errors of Robotic vs. Laparoscopic Radical Right Hemiclectomy
Lead Sponsor:
The Affiliated Hospital of Qingdao University
Conditions:
Colorectal Carcinoma (CRC)
Right Hemicolectomy
Eligibility:
All Genders
18-80 years
Phase:
NA
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 betwee...
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 Onco...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
368 Patients enrolled
Trial Details
Trial ID
NCT07138859
Start Date
August 1 2025
End Date
December 1 2030
Last Update
August 24 2025
Active Locations (1)
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1
The Affiliated Hospital of Qingdao University
Shandong, Province, China, 266071