Clinical trial NCT06454253: Short- and Long-term Outcomes of Robotic vs Laparoscopic Right Colon Cancer: a 10-year Single-center Retrospective Study
Official title: the Ethics Committee of the First Affiliated Hospital of Nanchang University
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Robotic
Laparoscopic
Colon Cancer
Long-term Outcomes
Short-term Outcomes
Lead sponsor: Nanchang University
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 1879
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The consecutive cases of robotic-assisted or laparoscopic-assisted right colectomy between December 2014 and March 2024. All cases derived from the First Affiliated Hospital of Nanchang University.

Brief 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.

Detailed 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.

Eligibility criteria: 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. -

Primary outcomes:
measure: overall survival
timeFrame: 5 years after surgery
measure: disease-free survival
timeFrame: 5 years after surgery
Secondary outcomes:
measure: the rate of postoperative complications
timeFrame: 1 months after surgery
measure: operative time
timeFrame: Intraoperative
measure: estimation of blood loss
timeFrame: Intraoperative
measure: number of retrieved lymph nodes
timeFrame: Intraoperative
measure: days after postoperative hospital stay
timeFrame: 1 months after surgery
measure: time to first exhaust
timeFrame: 1 weeks after surgery
measure: time to liquid diet
timeFrame: 1 weeks after surgery
measure: the rate of intracorporeal anastomosis
timeFrame: 1 months after surgery
Other outcomes:
Locations:
Study officials:
References: