Voice of China What are the benefits of robotic surgery for patients with low- and middle-grade rectal cancer? Chinese data gives the answer!

Coloral cancer is one of the most common malignancies in the world, and surgical resection is an important radical means
of curing colorectal cancer.
With the advancement of surgical technology, minimally invasive surgery has been widely recognized clinically
because of its advantages of small trauma and fast recovery.
In recent years, in addition to traditional laparoscopic surgery, the application of robotic surgery has become more and more extensive, but there are no large-scale studies comparing the impact of robotic surgery and traditional laparoscopic surgery on the survival benefits of colorectal cancer patients, coupled with the more expensive medical costs of robotic surgery than traditional laparoscopic surgery, some doctors and patients still have doubts about
the application of robotic surgery 。 Therefore, the team of Professor Xu Jianmin of Zhongshan Hospital affiliated to Fudan University designed the REAL study to compare the surgical quality and long-term oncology results of robotic surgery in low- and medium-grade rectal cancer compared to traditional laparoscopic surgery
, and the short-term results of the study were published in Lancet Gastroenterology & Hepatology (IF:45.
042).

Minimally invasive surgery is one of the directions of contemporary surgical development, because rectal tumors are located in the deep pelvic cavity, and the maneuverable space is small, so the operation of traditional laparoscopic surgery is more
difficult.
The advent of robotic surgery has greatly improved this situation, especially for low- and medium-grade rectal cancer, and a robotic platform with three-dimensional vision, stable camera equipment and flexible arms can effectively help improve
the quality of laparoscopic surgery.
However, there is no high-quality evidence-based medical evidence to judge
the merits of robotic surgery and traditional laparoscopic surgery in terms of patient survival benefits.
Against this background, the researchers initiated the REAL trial in 2016 and here reports a preliminary analysis
of the study's short-term results.

The REAL study is a national, multicenter, randomized, controlled, nonblind clinical study in which patients with low and middle rectal cancer with cT1-T3 N0-1 or ycT1-T3 Nx after neoadjuvant therapy and no distant metastases are included in the inclusion criteria of the study as low and middle rectal cancer defined as the lower margin of the tumor ≤ 10 cm
from the margin.
Patients are randomly assigned (1:1) to undergo robotic surgery or traditional laparoscopic surgery, all following the principles
of mesangial resection or partial mesangial resection.
The primary endpoints of the study were 3-year local recurrence rate, and the positive rate of circumferential margin (CRM) and the complication rate of 30 days postoperative were the two key secondary endpoints of the study, and other secondary endpoints included intraoperative outcomes, pathological outcomes, and postoperative recovery
.

From July 2016 to December 2020, a total of 1240 patients were included in the study, of which 1171 patients were included in the intending treatment analysis population, including 586 cases in the robotic surgery group and 585 cases in the laparoscopic surgery group
.

Figure 1 Patient enrollment

Because data on the local recurrence rate of the primary endpoint of the study are not yet mature, the researchers analyzed the secondary endpoint results here, which included two key secondary endpoints, CRM positive rate and complication rate
at 30 days postoperatively.

Analysis of pathological results showed that the complete resection rate of tumors under the naked eye was higher in the robotic surgery group than in the laparoscopic surgery group (95.
4% vs.
91.
8%, P=0.
042), and the CRM positive rate was lower than that in the laparoscopic surgery group (4.
0% vs.
7.
2%, p=0.
023).

The median lymph node acquisition in the robotic surgery group was 15, significantly higher than the 14 lymph nodes in the laparoscopic surgery group (p=0.
006), and other pathological results were shown in
Table 1.

Table 1 Analysis of pathological results of patients

An analysis of postoperative complications is shown in Table 3, with one patient in each of the two groups dying
within 30 days of surgery.
The incidence of postoperative complications of Clavien-Dindo grade II and above in the robotic surgery group within 30 days after surgery was 16.
2%, which was significantly lower than that in the laparoscopic surgery group of 23.
1% (p=0.
003).

A hierarchical analysis of complications showed that the incidence of postoperative complications in the robotic surgery group was also lower than that in the laparoscopic surgery group (13.
3% vs.
18.
3%)
.

Anastomotic fistula occurred in 5.
1% and 8.
2% of patients in the robotic surgery group and 8.
2% of patients in the laparoscopic surgery group, respectively, of which the incidence of Clavien-Dindo grade II anastomotic fistula was 4.
3% and 4.
5%, respectively, and the incidence of grade III anastomotic fistula was 0.
6% and 2.
9%,
respectively.

The postoperative recovery rate in the robotic surgery group was better than that in the laparoscopic surgery group, regardless of the median first exhaust time (38.
0h vs.
44.
0h; p=0.
003), median time to first bowel movement (72.
0h vs.
83.
9h; p<0.
0001) or median postoperative hospital stay (7.
0 days vs 8.
0 days; p=0.
0001), the robotic surgery group performed better
.

Table 2 Analysis of the incidence and recovery of postoperative complications in patients

The analysis of the surgical results is shown in Table 3, and all procedures are completed within 5 days of randomization
.
In terms of surgical type, the combined abdominal perineal resection was performed in the robotic surgery group (16.
9% vs.
22.
7%), and the proportion of patients who switched to open surgery was even lower (1.
7% vs.
3.
9%)
.
In addition, the median expected blood loss for robotic surgery was lower (400 mL vs.
500 mL; p<0.
0001), the incidence of intraoperative complications was lower (5.
5% vs.
8.
7%; p=0.
030）
。

Table 3 Analysis of surgical results

For patients with low- to medium-grade rectal cancer, the REAL trial is the first randomized controlled study to suggest the benefits of robotic surgery versus traditional laparoscopic surgery in terms of surgical quality and postoperative complications, with fewer surgical traumas and better postoperative recovery after robotic surgery, and the long-term survival analysis of the study is expected to be published in December 2023, and Yimaitong will continue to pay attention to the progress
of the study.

References

Feng Q, Yuan W, Li T, et al.
Robotic versus laparoscopic surgery for middle and low rectal cancer (REAL): short-term outcomes of a multicentre randomised controlled trial [published online ahead of print, 2022 Sep 7].
Lancet Gastroenterol Hepatol.
2022; S2468-1253(22)00248-5.

Reviewer: Traveler

Typesetting: Youshi

Executive: Tourist