Short- and Long-term Outcomes of Robotic vs Laparoscopic Right Colon Cancer: a 10-year Single-center Retrospective Study

the Ethics Committee of the First Affiliated Hospital of Nanchang University

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.

Study Overview

• Status: Completed
• Conditions: Colon Cancer; Laparoscopic; Robotic; Long-term Outcomes; Short-term Outcomes
• Intervention / Treatment: Device: Da Vinci Robot Surgical System

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.

• Study Type: Observational
• Enrollment (Actual): 1879

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
robot-assisted right colon group; Robot assisted radical surgery for right colon cancer	Device: Da Vinci Robot Surgical System; Performing surgery on right colon cancer patients using the da Vinci robotic surgical system or laparoscopic surgical system; Other Names: Laparoscopic surgical system
laparoscopic-assisted right colon group; Laparoscopic assisted radical surgery for right colon cancer	Device: Da Vinci Robot Surgical System; Performing surgery on right colon cancer patients using the da Vinci robotic surgical system or laparoscopic surgical system; Other Names: Laparoscopic surgical system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	months	5 years after surgery
disease-free survival	months	5 years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
operative time	minutes	Intraoperative
estimation of blood loss	milliliters	Intraoperative
the rate of postoperative complications	rate	1 months after surgery
number of retrieved lymph nodes	numbers	Intraoperative
days after postoperative hospital stay	days	1 months after surgery
time to first exhaust	hours	1 weeks after surgery
time to liquid diet	hours	1 weeks after surgery
the rate of intracorporeal anastomosis	rate	1 months after surgery

Collaborators and Investigators

• Sponsor: Taiyuan Li

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: June 8, 2024
• First Posted (Actual): June 12, 2024

Study Record Updates

• Last Update Posted (Actual): June 12, 2024
• Last Update Submitted That Met QC Criteria: June 8, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: IIT2023015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Access to the database can be obtained from the corresponding author on reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No