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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06454253
Other study ID # IIT2023015
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2014
Est. completion date April 30, 2024

Study information

Verified date June 2024
Source Nanchang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to evaluate the short-term outcomes and long-term outcomes of robot-assisted right colon group for cancer compared to laparoscopic-assisted right colon group. This is a large sample study based on ten years of clinical data. The main question it aims to answer is: What are the advantages of da Vinci robot right hemicolectomy compared to laparoscopic right hemicolectomy, and is there a difference in long-term efficacy between the two methods.


Description:

Colorectal cancer (CRC) is highly prevalent worldwide. In China, CRC ranks high among the population of men and women with cancer. The incidence and mortality rates of CRC are rising quickly in developing countries, and it is the fourth most deadly cancer in the world. In particular, the right colon cancer (RCC) is continuously growing in China, and the early symptoms of RCC are not typical. one of the most useful ways for RCC is surgical is a surgical operation. Along with the development of minimally invasive surgery, the use of laparoscopy for colon cancer is widely accepted and has become one symbolic surgical technology. Studies have demonstrated that laparoscopic colonic surgery is related to reduced pain after operation, shorter rehabilitation time, shorter length of hospital stay, reduced the time of ileus after surgery, and reduced surgical site infection. Nevertheless, laparoscopic surgery also has its shortcoming, including a limited range of motion, slow learning and growth, and physiological tremor cannot be eliminated.The emergence of robots has broken the inherent disadvantage of laparoscopy. It has achieved similar or better results in previous studies. Based on these advantages, robotic surgery has received much attention from the surgeons. With the first robotic surgery in the field of colon cancer was reported in 2002, there are some studies proved the safety and feasibility by using robot,However, most studies with small sample sizes and with cases at a relatively early stage. Therefore, the purpose of this study is to compare the short-term and long-term outcomes between RARC and LARC in the treatment of right colon cancer in our center.


Recruitment information / eligibility

Status Completed
Enrollment 1879
Est. completion date April 30, 2024
Est. primary completion date March 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: 1. The age is more than 18 years old and less than or equal to 85 years old 2. No distant metastasis (including pelvic cavity, peritoneum, liver, lung, brain, bone, distant lymph node metastasis, etc.) is judged by ultrasound, CT, PET-CT, etc 3. Preoperative colonoscopy showing that the tumor was located in the ileocecal region, ascending colon, hepatic flexure, or transverse colon with pathology showing malignancy 4. signed informed consent. - Exclusion Criteria: 1. multiple primary colorectal cancer 2. recurrent right colon cancer 3. preoperative neoadjuvant chemotherapy 4. emergency surgery for intestinal obstruction, bleeding or perforation 5. incomplete data and missing follow-up data. -

Study Design


Intervention

Device:
Da Vinci Robot Surgical System
Performing surgery on right colon cancer patients using the da Vinci robotic surgical system or laparoscopic surgical system

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Taiyuan Li

Outcome

Type Measure Description Time frame Safety issue
Primary overall survival months 5 years after surgery
Primary disease-free survival months 5 years after surgery
Secondary the rate of postoperative complications rate 1 months after surgery
Secondary operative time minutes Intraoperative
Secondary estimation of blood loss milliliters Intraoperative
Secondary number of retrieved lymph nodes numbers Intraoperative
Secondary days after postoperative hospital stay days 1 months after surgery
Secondary time to first exhaust hours 1 weeks after surgery
Secondary time to liquid diet hours 1 weeks after surgery
Secondary the rate of intracorporeal anastomosis rate 1 months after surgery
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