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Effectiveness of Robotic Surgery for Right Colon Cancer
Condition(s) studied
Colon CancerRobotic Surgery
Investigational drug(s) / intervention(s)
DaVinci si or xi systemlaparoscopic radical resection
DaVinci si or xi system: In this study, subjects were randomly divided into an experimental group (robot-assisted radical resection of right colon cancer group, referred to as robotic surgery group) and a control group (laparoscopic radical resection of right colon cancer group, referred to as laparoscopic surgery group).
laparoscopic radical resection: In this study, subjects were randomly divided into an experimental group (robot-assisted radical resection of right colon cancer group, referred to as robotic surgery group) and a control group (laparoscopic radical resection of right colon cancer group, referred to as laparoscopic surgery group).
Study summary
This study aims to explore through a multi-center, randomized controlled clinical study whether robot-assisted radical resection of right colon cancer is superior to laparoscopic surgery in terms of surgical quality and oncological prognosis.
Eligibility
Inclusion Criteria:
1. Age 18-75 years old.
2. ASA classification ≤ Level III.
3. Colon adenocarcinoma was confirmed by colonoscopy and biopsy pathology.
4. Transabdominal enhanced CT showed that the distal and proximal ends of the primary tumor were located in the right colon (cecum to the proximal 1/3 of the transverse colon).
5. Preoperative clinical stage: TanyNanyM0.
6. The patient's condition meets the indications for robotic surgery and is willing to accept the robotic surgery treatment plan.
7. Voluntarily participate in this study and sign the informed consent form. If the subject is unable to read and sign the informed consent form due to incapacity or other reasons, his or her guardian must be responsible for the informed process and sign the informed consent form. If the subject is unable to read the informed consent form (such as illiterate subjects), a witness must witness the informed process and sign the informed consent form.
Exclusion Criteria:
1. Preoperative examination indicates synchronous multiple primary colorectal cancers or other diseases requiring intestinal segmental resection.
2. The results of preoperative imaging examination or intraoperative exploration suggest: 1) The tumor involves surrounding organs and requires combined organ resection; 2) There is distant metastasis; 3) R0 resection cannot be performed.
3. Additional radical surgery after emr and esd surgery.
4. Have a history of any other malignant tumor or familial adenomatous polyposis in the past 5 years, except for cured cervical carcinoma in situ, basal cell carcinoma, papillary thyroid carcinoma or cutaneous squamous cell carcinoma.
5. Combined intestinal obstruction, intestinal perforation, intestinal bleeding, etc. require emergency surgery.
6. Patients who are not suitable for or cannot tolerate robotic or laparoscopic surgery.
7. Pregnant or lactating women.
8. Patients with a history of mental illness.
9. Patients who have received neoadjuvant treatment before surgery.
10. MDT discusses patients who are not suitable for entering the study.
11. Patients who refuse to undergo either robotic or laparoscopic surgery.
Primary outcome measure(s)
- 3-year disease-free survival rate — From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
The time from randomization to first tumor recurrence/metastasis or death from any cause was defined as the time of last follow-up for patients lost to follow-up(Patients still alive at the end of the study, the end of follow-up).
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Sir Run Run Shao hospital |
Hanzhou |
Zhejiang |
|
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