# Short-term Outcomes of Laparoscopy-Assisted vs Open Surgery for Patients With Low Rectal Cancer: The LASRE Randomized Clinical Trial

## TL;DR

This study found that laparoscopic surgery for low rectal cancer is as safe and effective as open surgery in the short term, with better recovery and sphincter preservation.

## Contribution

Demonstrated that laparoscopic surgery is non-inferior to open surgery for low rectal cancer in short-term oncologic outcomes.

## Key findings

- Laparoscopic surgery had comparable complete mesorectal excision and resection margin rates to open surgery.
- Laparoscopic surgery showed a higher sphincter preservation rate and shorter hospitalization.
- Postoperative complication rates were similar between the two surgical methods.

## Abstract

This randomized clinical trial compares the short-term efficacy of laparoscopic surgery vs open surgery for treatment of low rectal cancer.

Is laparoscopic surgery safe for treatment of low rectal cancer in terms of short-term oncologic outcomes?

In this randomized clinical trial including 1039 patients, laparoscopic surgery had a comparable rate of complete total mesorectal excision (85.3% vs 85.8% in open surgery). The rate of negative circumferential and distal resection margins was 98.2% vs 99.7% and 99.4% vs 100%, respectively, and the median number of lymph nodes retrieved was 13.0 vs 12.0, respectively; laparoscopic surgery had a higher sphincter preservation rate and favorable postoperative recovery.

Compared with open surgery, laparoscopic surgery was shown to be safe for treatment of low rectal cancer in terms of short-term oncologic outcomes.

The efficacy of laparoscopic vs open surgery for patients with low rectal cancer has not been established.

To compare the short-term efficacy of laparoscopic surgery vs open surgery for treatment of low rectal cancer.

This multicenter, noninferiority randomized clinical trial was conducted in 22 tertiary hospitals across China. Patients scheduled for curative-intent resection of low rectal cancer were randomized at a 2:1 ratio to undergo laparoscopic or open surgery. Between November 2013 and June 2018, 1070 patients were randomized to laparoscopic (n = 712) or open (n = 358) surgery. The planned follow-up was 5 years. Data analysis was performed from April 2021 to March 2022.

Eligible patients were randomized to receive either laparoscopic or open surgery.

The short-term outcomes included pathologic outcomes, surgical outcomes, postoperative recovery, and 30-day postoperative complications and mortality.

A total of 1039 patients (685 in laparoscopic and 354 in open surgery) were included in the modified intention-to-treat analysis (median [range] age, 57 [20-75] years; 620 men [59.7%]; clinical TNM stage II/III disease in 659 patients). The rate of complete mesorectal excision was 85.3% (521 of 685) in the laparoscopic group vs 85.8% (266 of 354) in the open group (difference, −0.5%; 95% CI, −5.1% to 4.5%; P = .78). The rate of negative circumferential and distal resection margins was 98.2% (673 of 685) vs 99.7% (353 of 354) (difference, −1.5%; 95% CI, −2.8% to 0.0%; P = .09) and 99.4% (681 of 685) vs 100% (354 of 354) (difference, −0.6%; 95% CI, −1.5% to 0.5%; P = .36), respectively. The median number of retrieved lymph nodes was 13.0 vs 12.0 (difference, 1.0; 95% CI, 0.1-1.9; P = .39). The laparoscopic group had a higher rate of sphincter preservation (491 of 685 [71.7%] vs 230 of 354 [65.0%]; difference, 6.7%; 95% CI, 0.8%-12.8%; P = .03) and shorter duration of hospitalization (8.0 vs 9.0 days; difference, −1.0; 95% CI, −1.7 to −0.3; P = .008). There was no significant difference in postoperative complications rate between the 2 groups (89 of 685 [13.0%] vs 61 of 354 [17.2%]; difference, −4.2%; 95% CI, −9.1% to −0.3%; P = .07). No patient died within 30 days.

In this randomized clinical trial of patients with low rectal cancer, laparoscopic surgery performed by experienced surgeons was shown to provide pathologic outcomes comparable to open surgery, with a higher sphincter preservation rate and favorable postoperative recovery.

ClinicalTrials.gov Identifier: NCT01899547